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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03104400
Registration number
NCT03104400
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017
Titles & IDs
Public title
A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
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Scientific title
A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1
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Secondary ID [1]
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2016-004130-24
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Secondary ID [2]
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M15-572
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Universal Trial Number (UTN)
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Trial acronym
SELECT - PsA 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo to Upadacitinib
Treatment: Drugs - Placebo to Adalimumab
Experimental: Upadacitinib 15 mg - Period 1: Participants receive upadacitinib 15 mg orally once a day (QD) and matching placebo to adalimumab by subcutaneous injection every other week (EOW) for 56 weeks.
Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Experimental: Upadacitinib 30 mg - Period 1: Participants receive upadacitinib 30 mg orally once a day and matching placebo to adalimumab by subcutaneous injection every other week for 56 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Active comparator: Adalimumab - Period 1: Participants receive adalimumab 40 mg by subcutaneous injection every other week and matching placebo to upadacitinib orally QD for 56 weeks.
Period 2: Participants continue to receive adalimumab 40 mg every other week.
Placebo comparator: Placebo / Upadacitinib 15 mg - Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 15 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.
Period 2: Participants will continue to receive upadacitinib 15 mg once daily.
Placebo comparator: Placebo / Upadacitinib 30 mg - Period 1: Participants receive matching placebo to upadacitinib orally once a day for 24 weeks then upadacitinib 30 mg once daily for 32 weeks, and matching placebo to adalimumab by subcutaneous injection EOW for the entire 56 weeks.
Period 2: Participants will continue to receive upadacitinib 30 mg once daily.
Treatment: Drugs: Adalimumab
Administered by subcutaneous injection
Treatment: Drugs: Upadacitinib
Oral tablet
Treatment: Drugs: Placebo to Upadacitinib
Oral tablet
Treatment: Drugs: Placebo to Adalimumab
Administered by subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
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Assessment method [1]
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Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 20% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
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Assessment method [1]
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The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving a Static Investigator Global Assessment (sIGA) of Psoriasis of 0 or 1 and at Least a 2-point Improvement From Baseline (sIGA 0/1) at Week 16
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Assessment method [2]
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The sIGA is a 5 point scale ranging from 0 to 4, based on the investigator's assessment of the average elevation, erythema, and scaling of all psoriatic lesions at the current visit. A lower score indicates less severe psoriasis (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe).
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Timepoint [2]
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Baseline and Week 16
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Secondary outcome [3]
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Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response at Week 16
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Assessment method [3]
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PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).
The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement = 3%.
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Timepoint [3]
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Baseline and Week 16
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Secondary outcome [4]
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Change From Baseline in Modified PsA Total Sharp/Van Der Heijde Score (mTSS) at Week 24
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Assessment method [4]
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The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.
Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).
Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).
Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.
The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst). A negative change from Baseline indicates improvement in joint damage.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
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Assessment method [5]
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A participant was classified as achieving MDA if 5 of the following 7 criteria were met:
* Tender joint count (out of 68 joints) = 1
* Swollen joint count (out of 66 joints) = 1
* PASI score = 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis = 3%
* Patient's assessment of pain = 1.5 (NRS from 0 to 10)
* Patient's Global Assessment of disease activity = 2 (NRS from 0 to 10)
* HAQ-DI score = 0.5 (index score ranges from 0 to 3)
* Leeds Enthesitis Index = 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Percentage of Participants With Resolution of Enthesitis at Week 24
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Assessment method [6]
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Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.
LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Percentage of Participants With an ACR20 Response at Week 12 - Non-inferiority Versus Adalimumab
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Assessment method [7]
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Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 20% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [7]
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Baseline and Week 12
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Secondary outcome [8]
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Change From Baseline in Short-Form 36 (SF-36) Physical Component Score (PCS) at Week 12
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Assessment method [8]
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The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).
The physical component score is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The PCS was calculated using norm-based scoring so that 50 is the average score and the standard deviation equals 10. Higher scores are associated with better functioning/quality of life; a positive change from Baseline score indicates an improvement.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 12
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Assessment method [9]
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The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 'not at all' to 4 'very much'. The FACIT Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
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Timepoint [9]
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Baseline and Week 12
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Secondary outcome [10]
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Percentage of Participants With an ACR20 Response at Week 12 - Superiority Versus Adalimumab
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Assessment method [10]
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Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 20% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [10]
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Baseline and Week 12
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Secondary outcome [11]
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Percentage of Participants With Resolution of Dactylitis at Week 24
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Assessment method [11]
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Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.
The Leeds Dactylitis Index (LDI) is a score based on finger circumference and tenderness, assessed and summed across all dactylitic digits (fingers and toes). The presence of a dactylitic digit is defined as at least one affected AND tender digit with circumference increase over reference digit = 10%. The reference digit circumference is either the contralateral digit (unaffected digit on opposite hand or foot) if available, or from a standard reference table if otherwise. Tenderness of affected digits is assessed on a scale from 0 \[none\] to 3 \[worst\].
The ratio of circumference between an affected digit and reference digit is multiplied by the tenderness score for each affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.
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Timepoint [11]
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Week 24
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Secondary outcome [12]
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Change From Baseline in Patient's Assessment of Pain - Superiority Versus Adalimumab
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Assessment method [12]
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Participants were asked to indicate the severity of their arthritis pain within the previous week on a numerical rating scale (NRS) from 0 to 10. A score of 0 indicates "no pain" and a score of 10 indicates "worst possible pain." A negative change from Baseline indicates improvement.
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Timepoint [12]
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Baseline and Week 12
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Secondary outcome [13]
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Change From Baseline in HAQ-DI - Superiority Versus Adalimumab
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Assessment method [13]
0
0
The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.
A negative change from Baseline in the overall score indicates improvement.
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Timepoint [13]
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Baseline and Week 12
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Secondary outcome [14]
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Change From Baseline in Self-Assessment of Psoriasis Symptoms (SAPS) Questionnaire at Week 16
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Assessment method [14]
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The SAPS is an 11-item self-assessment of psoriasis symptoms that includes questions on: pain, itching, redness, scaling, flaking, bleeding, burning, stinging, tenderness, pain due to skin cracking, and joint pain. Each item is scored from 0 to 10, with 0 being least severe and 10 being most severe. The total score is generated by summing the 11 items and ranges from 0 to 110 (worst). A negative change from Baseline in the total score indicates improvement.
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Timepoint [14]
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Baseline and Week 16
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Secondary outcome [15]
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Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
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Assessment method [15]
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Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:
1. = 50% improvement in 68-tender joint count;
2. = 50% improvement in 66-swollen joint count; and
3. = 50% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [15]
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Baseline and Week 12
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Secondary outcome [16]
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Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12
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Assessment method [16]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:
1. = 70% improvement in 68-tender joint count;
2. = 70% improvement in 66-swollen joint count; and
3. = 70% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [16]
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Baseline and Week 12
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Secondary outcome [17]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2
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Assessment method [17]
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Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:
1. = 20% improvement in 68-tender joint count;
2. = 20% improvement in 66-swollen joint count; and
3. = 20% improvement in at least 3 of the 5 following parameters:
* Physician global assessment of disease activity
* Patient global assessment of disease activity
* Patient assessment of pain
* Health Assessment Questionnaire - Disability Index (HAQ-DI)
* High-sensitivity C-reactive protein (hsCRP).
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Timepoint [17]
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Baseline and Week 2
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Eligibility
Key inclusion criteria
* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
* Participant has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
* Presence of either at Screening:
1. >= 1 erosion on x-ray as determined by central imaging review or;
2. high-sensitivity C-reactive protein (hs-CRP) > laboratory defined upper limit of normal (ULN).
* Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
* Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
* Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for >= 12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:
1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
2. >= 4 weeks for all others.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib).
* Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/04/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1705
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 166780 - Botany
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Recruitment hospital [2]
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The Queen Elizabeth Hospital /ID# 169333 - Woodville
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Recruitment hospital [3]
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Barwon Rheumatology /ID# 166782 - Geelong
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Recruitment hospital [4]
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Heidelberg Repatriation Hospital /ID# 167450 - Heidelberg West
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Recruitment postcode(s) [1]
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2019 - Botany
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Recruitment postcode(s) [2]
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5011 - Woodville
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3081 - Heidelberg West
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Idaho
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Illinois
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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United States of America
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State/province [30]
0
0
Texas
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Washington
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
West Virginia
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Wisconsin
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Ciuadad Autonoma De Buenos Aires
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Tucuman
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Buenos Aires
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Caba
Query!
Country [39]
0
0
Argentina
Query!
State/province [39]
0
0
Rosario, Santa FE
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
SAN Miguel DE Tucuman, Latam
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Santa Fe
Query!
Country [42]
0
0
Belarus
Query!
State/province [42]
0
0
Brest
Query!
Country [43]
0
0
Belarus
Query!
State/province [43]
0
0
Grodno
Query!
Country [44]
0
0
Belarus
Query!
State/province [44]
0
0
Minsk
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Genk
Query!
Country [46]
0
0
Bosnia and Herzegovina
Query!
State/province [46]
0
0
Republika Srpska
Query!
Country [47]
0
0
Bosnia and Herzegovina
Query!
State/province [47]
0
0
Mostar
Query!
Country [48]
0
0
Bosnia and Herzegovina
Query!
State/province [48]
0
0
Sarajevo
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Goias
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Minas Gerais
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Parana
Query!
Country [52]
0
0
Brazil
Query!
State/province [52]
0
0
Rio Grande Do Sul
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Sao Paulo
Query!
Country [54]
0
0
Bulgaria
Query!
State/province [54]
0
0
Plovdiv
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Sofia
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Stara Zagora
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Varna
Query!
Country [58]
0
0
Canada
Query!
State/province [58]
0
0
British Columbia
Query!
Country [59]
0
0
Canada
Query!
State/province [59]
0
0
Manitoba
Query!
Country [60]
0
0
Canada
Query!
State/province [60]
0
0
Ontario
Query!
Country [61]
0
0
Canada
Query!
State/province [61]
0
0
Quebec
Query!
Country [62]
0
0
Chile
Query!
State/province [62]
0
0
Region Metropolitana De Santiago
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Providencia
Query!
Country [64]
0
0
Chile
Query!
State/province [64]
0
0
Santiago
Query!
Country [65]
0
0
Chile
Query!
State/province [65]
0
0
Vitacura Santiago
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Anhui
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Beijing
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Guangdong
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Hunan
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Inner Mongolia
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Shandong
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Shanghai
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Sichuan
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Zhejiang
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Huhehaote
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Kunming
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Nantong
Query!
Country [78]
0
0
China
Query!
State/province [78]
0
0
Soochow
Query!
Country [79]
0
0
China
Query!
State/province [79]
0
0
Urumqi
Query!
Country [80]
0
0
Colombia
Query!
State/province [80]
0
0
Cundinamarca
Query!
Country [81]
0
0
Colombia
Query!
State/province [81]
0
0
Antioquia
Query!
Country [82]
0
0
Colombia
Query!
State/province [82]
0
0
Barranquilla
Query!
Country [83]
0
0
Colombia
Query!
State/province [83]
0
0
Chia
Query!
Country [84]
0
0
Colombia
Query!
State/province [84]
0
0
Medellín
Query!
Country [85]
0
0
Croatia
Query!
State/province [85]
0
0
Grad Zagreb
Query!
Country [86]
0
0
Croatia
Query!
State/province [86]
0
0
Primorsko-goranska Zupanija
Query!
Country [87]
0
0
Croatia
Query!
State/province [87]
0
0
Zagreb
Query!
Country [88]
0
0
Czechia
Query!
State/province [88]
0
0
Praha 4
Query!
Country [89]
0
0
Czechia
Query!
State/province [89]
0
0
Bruntál
Query!
Country [90]
0
0
Czechia
Query!
State/province [90]
0
0
Ostrava
Query!
Country [91]
0
0
Czechia
Query!
State/province [91]
0
0
Uherské Hradište
Query!
Country [92]
0
0
Estonia
Query!
State/province [92]
0
0
Harjumaa
Query!
Country [93]
0
0
Estonia
Query!
State/province [93]
0
0
Tartumaa
Query!
Country [94]
0
0
Estonia
Query!
State/province [94]
0
0
Tallinn
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Nordrhein-Westfalen
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Berlin-buch
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Dresden
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Duesseldorf
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Frankfurt
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Hamburg
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Rendsburg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Tuebingen
Query!
Country [103]
0
0
Greece
Query!
State/province [103]
0
0
Attiki
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Athens
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Heraklion
Query!
Country [106]
0
0
Greece
Query!
State/province [106]
0
0
Larisa
Query!
Country [107]
0
0
Hong Kong
Query!
State/province [107]
0
0
Hong Kong
Query!
Country [108]
0
0
Hong Kong
Query!
State/province [108]
0
0
Tuen Mun
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Bekes
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Pest
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Szabolcs-Szatmar-Bereg
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Zala
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Budapest
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Debrecen
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Veszprem
Query!
Country [116]
0
0
Ireland
Query!
State/province [116]
0
0
Dublin
Query!
Country [117]
0
0
Ireland
Query!
State/province [117]
0
0
Limerick
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Tel-Aviv
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Haifa
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Ramat Gan
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Campania
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Emilia-Romagna
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Lazio
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Ancona
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Catania
Query!
Country [126]
0
0
Japan
Query!
State/province [126]
0
0
Aichi
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Fukuoka
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Mie
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Osaka
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Tokyo
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Gyeonggido
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Incheon Gwang Yeogsi
Query!
Country [133]
0
0
Latvia
Query!
State/province [133]
0
0
Adazi
Query!
Country [134]
0
0
Latvia
Query!
State/province [134]
0
0
Liepaja
Query!
Country [135]
0
0
Latvia
Query!
State/province [135]
0
0
Riga
Query!
Country [136]
0
0
Lithuania
Query!
State/province [136]
0
0
Kaunas
Query!
Country [137]
0
0
Lithuania
Query!
State/province [137]
0
0
Klaipeda
Query!
Country [138]
0
0
Lithuania
Query!
State/province [138]
0
0
Siauliai
Query!
Country [139]
0
0
Lithuania
Query!
State/province [139]
0
0
Vilnius
Query!
Country [140]
0
0
Malaysia
Query!
State/province [140]
0
0
Perak
Query!
Country [141]
0
0
Malaysia
Query!
State/province [141]
0
0
Seremban
Query!
Country [142]
0
0
Mexico
Query!
State/province [142]
0
0
Ciudad De Mexico
Query!
Country [143]
0
0
Mexico
Query!
State/province [143]
0
0
Jalisco
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
Chihuahua
Query!
Country [145]
0
0
Netherlands
Query!
State/province [145]
0
0
Leeuwarden
Query!
Country [146]
0
0
Netherlands
Query!
State/province [146]
0
0
Rotterdam
Query!
Country [147]
0
0
New Zealand
Query!
State/province [147]
0
0
Waikato
Query!
Country [148]
0
0
New Zealand
Query!
State/province [148]
0
0
Auckland
Query!
Country [149]
0
0
New Zealand
Query!
State/province [149]
0
0
Nelson
Query!
Country [150]
0
0
New Zealand
Query!
State/province [150]
0
0
Timaru
Query!
Country [151]
0
0
Norway
Query!
State/province [151]
0
0
Sogn Og Fjordane
Query!
Country [152]
0
0
Norway
Query!
State/province [152]
0
0
Sor-Trondelag
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Dolnoslaskie
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Kujawsko-pomorskie
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Lodzkie
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Malopolskie
Query!
Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Pomorskie
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Slaskie
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Warminsko-mazurskie
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Elblag
Query!
Country [161]
0
0
Poland
Query!
State/province [161]
0
0
Krakow
Query!
Country [162]
0
0
Poland
Query!
State/province [162]
0
0
Poznan
Query!
Country [163]
0
0
Poland
Query!
State/province [163]
0
0
Warsaw
Query!
Country [164]
0
0
Portugal
Query!
State/province [164]
0
0
Lisboa
Query!
Country [165]
0
0
Portugal
Query!
State/province [165]
0
0
Porto
Query!
Country [166]
0
0
Portugal
Query!
State/province [166]
0
0
Lisbon
Query!
Country [167]
0
0
Portugal
Query!
State/province [167]
0
0
Loures
Query!
Country [168]
0
0
Portugal
Query!
State/province [168]
0
0
Viana Do Castelo
Query!
Country [169]
0
0
Puerto Rico
Query!
State/province [169]
0
0
Carolina
Query!
Country [170]
0
0
Puerto Rico
Query!
State/province [170]
0
0
Ponce
Query!
Country [171]
0
0
Puerto Rico
Query!
State/province [171]
0
0
San Juan
Query!
Country [172]
0
0
Russian Federation
Query!
State/province [172]
0
0
Moskva
Query!
Country [173]
0
0
Russian Federation
Query!
State/province [173]
0
0
Novosibirskaya Oblast
Query!
Country [174]
0
0
Russian Federation
Query!
State/province [174]
0
0
Tatarstan, Respublika
Query!
Country [175]
0
0
Russian Federation
Query!
State/province [175]
0
0
Moscow
Query!
Country [176]
0
0
Russian Federation
Query!
State/province [176]
0
0
St. Petersburg
Query!
Country [177]
0
0
Serbia
Query!
State/province [177]
0
0
Beograd
Query!
Country [178]
0
0
Singapore
Query!
State/province [178]
0
0
Central Singapore
Query!
Country [179]
0
0
Singapore
Query!
State/province [179]
0
0
Singapore
Query!
Country [180]
0
0
Slovakia
Query!
State/province [180]
0
0
Martin
Query!
Country [181]
0
0
Slovakia
Query!
State/province [181]
0
0
Nové Mesto Nad Váhom
Query!
Country [182]
0
0
Slovakia
Query!
State/province [182]
0
0
Pieštany
Query!
Country [183]
0
0
Slovenia
Query!
State/province [183]
0
0
Ljubljana
Query!
Country [184]
0
0
Slovenia
Query!
State/province [184]
0
0
Maribor
Query!
Country [185]
0
0
Slovenia
Query!
State/province [185]
0
0
Murska Sobota
Query!
Country [186]
0
0
South Africa
Query!
State/province [186]
0
0
Eastern Cape
Query!
Country [187]
0
0
South Africa
Query!
State/province [187]
0
0
Gauteng
Query!
Country [188]
0
0
South Africa
Query!
State/province [188]
0
0
Western Cape
Query!
Country [189]
0
0
Spain
Query!
State/province [189]
0
0
A Coruna
Query!
Country [190]
0
0
Spain
Query!
State/province [190]
0
0
Granada
Query!
Country [191]
0
0
Spain
Query!
State/province [191]
0
0
Madrid
Query!
Country [192]
0
0
Switzerland
Query!
State/province [192]
0
0
Sankt Gallen
Query!
Country [193]
0
0
Switzerland
Query!
State/province [193]
0
0
Fribourg
Query!
Country [194]
0
0
Taiwan
Query!
State/province [194]
0
0
Taichung
Query!
Country [195]
0
0
Taiwan
Query!
State/province [195]
0
0
Taipei City
Query!
Country [196]
0
0
Taiwan
Query!
State/province [196]
0
0
Taoyuan City
Query!
Country [197]
0
0
Turkey
Query!
State/province [197]
0
0
Adana
Query!
Country [198]
0
0
Turkey
Query!
State/province [198]
0
0
Ankara
Query!
Country [199]
0
0
Turkey
Query!
State/province [199]
0
0
Istanbul
Query!
Country [200]
0
0
Turkey
Query!
State/province [200]
0
0
Meram Konya
Query!
Country [201]
0
0
Turkey
Query!
State/province [201]
0
0
Sakarya
Query!
Country [202]
0
0
Ukraine
Query!
State/province [202]
0
0
Kharkivska Oblast
Query!
Country [203]
0
0
Ukraine
Query!
State/province [203]
0
0
Lvivska Oblast
Query!
Country [204]
0
0
Ukraine
Query!
State/province [204]
0
0
Kharkiv
Query!
Country [205]
0
0
Ukraine
Query!
State/province [205]
0
0
Kiev
Query!
Country [206]
0
0
Ukraine
Query!
State/province [206]
0
0
Kyiv
Query!
Country [207]
0
0
Ukraine
Query!
State/province [207]
0
0
Odesa
Query!
Country [208]
0
0
Ukraine
Query!
State/province [208]
0
0
Vinnytsia
Query!
Country [209]
0
0
United Kingdom
Query!
State/province [209]
0
0
London, City Of
Query!
Country [210]
0
0
United Kingdom
Query!
State/province [210]
0
0
Christchurch
Query!
Country [211]
0
0
United Kingdom
Query!
State/province [211]
0
0
Coventry
Query!
Country [212]
0
0
United Kingdom
Query!
State/province [212]
0
0
Glasgow
Query!
Country [213]
0
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United Kingdom
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Luton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.
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Trial website
https://clinicaltrials.gov/study/NCT03104400
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Trial related presentations / publications
McInnes IB, Kato K, Magrey M, Merola JF, Kishimoto M, Haaland D, Chen L, Duan Y, Liu J, Lippe R, Wung P. Efficacy and Safety of Upadacitinib in Patients with Psoriatic Arthritis: 2-Year Results from the Phase 3 SELECT-PsA 1 Study. Rheumatol Ther. 2023 Feb;10(1):275-292. doi: 10.1007/s40744-022-00499-w. Epub 2022 Oct 15. Mease P, Kavanaugh A, Gladman D, FitzGerald O, Soriano ER, Nash P, Feng D, Lertratanakul A, Douglas K, Lippe R, Gossec L. Disease Control with Upadacitinib in Patients with Psoriatic Arthritis: A Post Hoc Analysis of the Randomized, Placebo-Controlled SELECT-PsA 1 and 2 Phase 3 Trials. Rheumatol Ther. 2022 Aug;9(4):1181-1191. doi: 10.1007/s40744-022-00449-6. Epub 2022 May 23. Burmester GR, Winthrop K, Blanco R, Nash P, Goupille P, Azevedo VF, Salvarani C, Rubbert-Roth A, Lesser E, Lippe R, Lertratanakul A, Mccaskill RM, Liu J, Ruderman EM. Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials. Rheumatol Ther. 2022 Apr;9(2):521-539. doi: 10.1007/s40744-021-00410-z. Epub 2021 Dec 30. Nash P, Richette P, Gossec L, Marchesoni A, Ritchlin C, Kato K, McDearmon-Blondell EL, Lesser E, McCaskill R, Feng D, Anderson JK, Ruderman EM. Upadacitinib as monotherapy and in combination with non-biologic disease-modifying antirheumatic drugs for psoriatic arthritis. Rheumatology (Oxford). 2022 Aug 3;61(8):3257-3268. doi: 10.1093/rheumatology/keab905. Strand V, Mease PJ, Soriano ER, Kishimoto M, Salvarani C, Saffore CD, Zueger P, McDearmon-Blondell E, Kato K, Gladman DD. Improvement in Patient-Reported Outcomes in Patients with Psoriatic Arthritis Treated with Upadacitinib Versus Placebo or Adalimumab: Results from SELECT-PsA 1. Rheumatol Ther. 2021 Dec;8(4):1789-1808. doi: 10.1007/s40744-021-00379-9. Epub 2021 Oct 12. Muensterman E, Engelhardt B, Gopalakrishnan S, Anderson JK, Mohamed MF. Upadacitinib pharmacokinetics and exposure-response analyses of efficacy and safety in psoriatic arthritis patients - Analyses of phase III clinical trials. Clin Transl Sci. 2022 Jan;15(1):267-278. doi: 10.1111/cts.13146. Epub 2021 Oct 27. McInnes IB, Anderson JK, Magrey M, Merola JF, Liu Y, Kishimoto M, Jeka S, Pacheco-Tena C, Wang X, Chen L, Zueger P, Liu J, Pangan AL, Behrens F. Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis. N Engl J Med. 2021 Apr 1;384(13):1227-1239. doi: 10.1056/NEJMoa2022516.
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Public notes
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Contacts
Principal investigator
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AbbVie Inc.
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AbbVie
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/00/NCT03104400/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/00/NCT03104400/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03104400