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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02198651




Registration number
NCT02198651
Ethics application status
Date submitted
22/07/2014
Date registered
24/07/2014

Titles & IDs
Public title
A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects
Scientific title
A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)
Secondary ID [1] 0 0
2014-001114-26
Secondary ID [2] 0 0
M14-500
Universal Trial Number (UTN)
Trial acronym
PREDICTRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Musculoskeletal and Connective Tissue Diseases 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adalimumab
Other interventions - Placebo

Experimental: Adalimumab 40 mg eow - 40 mg adalimumab administered subcutaneously every other week (eow) from Week 0 to Week 4 (Lead-in Period)

Active comparator: Adalimumab Tapering - 40 mg adalimumab administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

Placebo comparator: Adalimumab Withdrawal Arm - Placebo administered subcutaneously every three weeks from Week 4 to Week 40 (Double-blind Period)

Experimental: Adalimumab 40 mg eow Rescue Arm - 40 mg adalimumab administered subcutaneously every other week from Flare Week 0 to Flare Week 16 (Open-label Rescue Period)


Treatment: Other: Adalimumab
Pre-filled syringe, administered by subcutaneous injection

Other interventions: Placebo
Pre-filled syringe, administered by subcutaneous injection in the Double-blind period
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Association Between Baseline Hand and Wrist Synovitis Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score and Flare up to Week 40 in the Tapering Arm
Timepoint [1] 0 0
From Week 4 to Week 40
Primary outcome [2] 0 0
Association Between Baseline Bone Marrow Edema RAMRIS Score and Flare up to Week 40 in the Tapering Arm
Timepoint [2] 0 0
From Week 4 to Week 40
Primary outcome [3] 0 0
Association Between a Composite of Baseline Hand and Wrist Synovitis and Bone Marrow Edema RAMRIS Scores and Flare up to Week 40 in the Tapering Arm
Timepoint [3] 0 0
From Week 4 to Week 40
Secondary outcome [1] 0 0
Median Time to Flare
Timepoint [1] 0 0
From Week 4 to Week 40
Secondary outcome [2] 0 0
Physicians' Assessment of Flare Severity
Timepoint [2] 0 0
At the Flare Week 0 Visit
Secondary outcome [3] 0 0
Participants' Assessment of Flare Severity
Timepoint [3] 0 0
At the Flare Week 0 Visit
Secondary outcome [4] 0 0
Percentage of Participants With a Flare
Timepoint [4] 0 0
From Week 4 to Week 40
Secondary outcome [5] 0 0
Number of Participants Who Regained Clinical Remission in the Open-Label Rescue Arm Over Time
Timepoint [5] 0 0
From Flare Week 0 to Flare Week 16
Secondary outcome [6] 0 0
Median Time to Clinical Remission From the Occurrence of Flare
Timepoint [6] 0 0
From Flare Week 0 to Flare Week 16
Secondary outcome [7] 0 0
Mean Change From Double-blind Baseline in Disease Activity Score 28 (DAS28)
Timepoint [7] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [8] 0 0
Mean Change From Double-blind Baseline in Clinical Disease Activity Index (CDAI) Score
Timepoint [8] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [9] 0 0
Mean Change From Double-blind Baseline in Simplified Disease Activity Index (SDAI) Score
Timepoint [9] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [10] 0 0
Number of Participants Maintaining Clinical Remission Defined By DAS28 (ESR) < 2.6, SDAI = 3.3, and CDAI = 2.8 at Each Visit By Treatment Arm
Timepoint [10] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [11] 0 0
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Magnetic Resonance Imaging (MRI) Synovitis Score
Timepoint [11] 0 0
From Week 4 to Week 40 or Final visit
Secondary outcome [12] 0 0
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Marrow Edema (BME) Score
Timepoint [12] 0 0
From Week 4 to Week 40 or Final visit
Secondary outcome [13] 0 0
Mean Change From Double-blind Baseline to Week 40 or Final Visit in Bone Erosions Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Score
Timepoint [13] 0 0
From Week 4 to Week 40 or Final Visit
Secondary outcome [14] 0 0
Mean Change From Double-blind Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score Over Time
Timepoint [14] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [15] 0 0
Number of Participants With Health Assessment Questionnaire- Disability Index (HAQ-DI) Score = 0.5 at Double-blind Baseline and at Week 40
Timepoint [15] 0 0
Week 4 and Week 40
Secondary outcome [16] 0 0
Mean Change From Double-blind Baseline in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed During In-office Visits
Timepoint [16] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [17] 0 0
Mean Change From Flare Week 0 in Routine Assessment of Patient Index Data (RAPID3) Questionnaire Scores Assessed at Home
Timepoint [17] 0 0
Flare Week 0 and Flare Weeks 1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15
Secondary outcome [18] 0 0
Mean Change From Double-blind Baseline in Swollen Joint Count 28
Timepoint [18] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [19] 0 0
Mean Change From Double-blind Baseline in Swollen Joint Count 66
Timepoint [19] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [20] 0 0
Mean Change From Double-blind Baseline in Tender Joint Count 28
Timepoint [20] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [21] 0 0
Mean Change From Double-blind Baseline in Tender Joint Count 68
Timepoint [21] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [22] 0 0
Mean Change From Double-blind Baseline in Participant's Global Assessment of Disease Activity
Timepoint [22] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [23] 0 0
Mean Change From Double-blind Baseline in Participant's Global Assessment of Rheumatoid Arthritis Pain
Timepoint [23] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [24] 0 0
Mean Change From Double-blind Baseline in Physician's Global Assessment of Disease Activity
Timepoint [24] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [25] 0 0
Mean Change From Double-blind Baseline in Morning Stiffness Duration
Timepoint [25] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [26] 0 0
Mean Change From Double-blind Baseline in Morning Stiffness Severity
Timepoint [26] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [27] 0 0
Mean Change From Double-blind Baseline in Participant's Assessment of Sleep Disturbance
Timepoint [27] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [28] 0 0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Effectiveness Score
Timepoint [28] 0 0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [29] 0 0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Side Effects Score
Timepoint [29] 0 0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [30] 0 0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Convenience Score
Timepoint [30] 0 0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [31] 0 0
Mean Change From Double-blind Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score
Timepoint [31] 0 0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [32] 0 0
Mean Change From Double-blind Baseline in Work Productivity and Activity Impairment (WPAI) Overall Work Impairment and Activity Impairment Scores
Timepoint [32] 0 0
At Weeks 4, 28, and 40 and Flare Weeks 0, 10, and 16
Secondary outcome [33] 0 0
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Score
Timepoint [33] 0 0
At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [34] 0 0
Mean Change From Double-blind Baseline in Short-Form 36 Version 2 Health Survey (SF-36v2) Mental Component Summary (MCS) Score
Timepoint [34] 0 0
At Weeks 4, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [35] 0 0
Mean Change From Double-blind Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale
Timepoint [35] 0 0
At Weeks 4, 16, 28, and 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [36] 0 0
Mean Change From Double-blind Baseline in Serum Levels of C-reactive Protein (CRP)
Timepoint [36] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16
Secondary outcome [37] 0 0
Mean Change From Double-blind Baseline in Serum Levels of Erythrocyte Sedimentation Rate (ESR)
Timepoint [37] 0 0
From Week 4 to Week 40 and from Flare Week 0 to Flare Week 16

Eligibility
Key inclusion criteria
1. Participant had a diagnosis of rheumatoid arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) classification criteria and/or the ACR /European League Against Rheumatism (EULAR) 2010 classification criteria (any duration since diagnosis).
2. Participant must have met the following criteria:

* Must have been treated with adalimumab 40 mg subcutaneously every other week (sc eow) for at least 12 months prior to Week 0 Visit
* Must have been treated with concomitant methotrexate (MTX) at a stable dose (oral, sc or intramuscular (im) at any dose) for at least 12 weeks prior to Week 0 Visit or if not on MTX, must have been treated with other allowed conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at a stable dose for at least 12 weeks prior to Week 0 Visit or if not treated with csDMARDs must maintain this regimen for at least 12 weeks prior to Week 0 Visit.
3. Participant must be in sustained clinical remission based on the following:

* At least one documented 4 or 3 (if Patient's Global Assessment ; PGA is not available) variables Disease Activity Score 28 Erythrocyte sedimentation rate (DAS28 ESR) or DAS28 C-reactive protein (CRP) < 2.6 (or calculated based on documented components of the DAS28) in the participant's chart 6 months or longer prior to the Screening Visit;
* 4 variables DAS28 (ESR) assessed at Screening < 2.6, with all components including ESR assessed at Screening.
4. If participant was receiving concomitant allowed csDMARDs (in addition or not to MTX) the dose must have been stable for at least 12 weeks prior to the Week 0 Visit (e.g., chloroquine, hydroxychloroquine, sulfasalazine, gold formulations [including auranofin, gold sodium thiomalate, and aurothioglucose] and/or leflunomide).
5. If participant was receiving concomitant oral corticosteroids, prednisone or equivalent must have been < 10 mg/day and the dose must have been stable for at least 4 weeks prior to the Week 0 Visit.
6. If participant was receiving concomitant non-steroidal anti-inflammatory drugs (NSAIDs), tramadol or other equivalent opioids and/or non-opioid analgesics, the dose and/or therapeutic scheme must have been stable for at least 4 weeks prior to the Week 0 Visit.
7. Participant must have been able and willing to provide written informed consent and comply with the requirements of this study protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any 4 or 3 (if PGA is not available) variables DAS28 (ESR) or DAS28 (CRP) (or calculated based on documented components of the DAS28) assessed within 6 months prior to the Screening Visit = 2.6.
2. Participant was on an additional concomitant biological disease-modifying anti-rheumatic drug (bDMARD) (including but not limited to abatacept, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab).
3. Participant had been treated with intra-articular or parenteral corticosteroids within the last four weeks before Screening.
4. Participant had undergone joint surgery within 12 weeks of Screening (at joints to be assessed by magnetic resonance imaging (MRI) and/or ultrasound).
5. Participant had a medical condition precluding an MRI (e.g. magnetic activated implanted devices - cardiac pace-maker, insulin pump, neuro stimulators, etc. and metallic devices or fragments or clips in the eye, brain or spinal canal and in the hand/wrist undergoing MRI)
6. Participant had a medical condition precluding a contrast MRI with gadolinium [e.g. nephrogenic systemic fibrosis, previous anaphylactic/anaphylactoid reaction to gadolinium containing contrast agent, pregnancy or breast feeding, severe renal insufficiency with an estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73m^2 at Screening, hepato-renal syndrome, severe chronic liver function impairment]
7. Participant had been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Screening Visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/08/2018
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 154649 - Camperdown
Recruitment hospital [2] 0 0
Optimus Clinical Research Pty. /ID# 133881 - Kogarah
Recruitment hospital [3] 0 0
John Hunter Hospital /ID# 133884 - Newcastle
Recruitment hospital [4] 0 0
Rheumatology Research Unit /ID# 133883 - Maroochydore
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2305 - Newcastle
Recruitment postcode(s) [4] 0 0
4558 - Maroochydore
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
France
State/province [17] 0 0
Poitou-Charentes
Country [18] 0 0
France
State/province [18] 0 0
Somme
Country [19] 0 0
France
State/province [19] 0 0
Chartres
Country [20] 0 0
France
State/province [20] 0 0
Grenoble
Country [21] 0 0
Germany
State/province [21] 0 0
Bad Abbach
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin-buch
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Cologne
Country [25] 0 0
Germany
State/province [25] 0 0
Hamburg
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Germany
State/province [27] 0 0
Ratingen
Country [28] 0 0
Germany
State/province [28] 0 0
Rendsburg
Country [29] 0 0
Greece
State/province [29] 0 0
Attiki
Country [30] 0 0
Greece
State/province [30] 0 0
Athens
Country [31] 0 0
Greece
State/province [31] 0 0
Heraklion
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
Hungary
State/province [33] 0 0
Debrecen
Country [34] 0 0
Ireland
State/province [34] 0 0
Dublin
Country [35] 0 0
Italy
State/province [35] 0 0
Lazio
Country [36] 0 0
Italy
State/province [36] 0 0
Bari
Country [37] 0 0
Italy
State/province [37] 0 0
Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Pavia
Country [39] 0 0
Italy
State/province [39] 0 0
Verona
Country [40] 0 0
Netherlands
State/province [40] 0 0
Amsterdam
Country [41] 0 0
Netherlands
State/province [41] 0 0
Arnhem
Country [42] 0 0
Netherlands
State/province [42] 0 0
Leeuwarden
Country [43] 0 0
Netherlands
State/province [43] 0 0
Utrecht
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Bilbao
Country [46] 0 0
Spain
State/province [46] 0 0
El Palmar
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Mostoles
Country [49] 0 0
Spain
State/province [49] 0 0
Santiago de Compostela
Country [50] 0 0
Spain
State/province [50] 0 0
Valencia
Country [51] 0 0
Sweden
State/province [51] 0 0
Uppsala Lan
Country [52] 0 0
Sweden
State/province [52] 0 0
Uppsala
Country [53] 0 0
Sweden
State/province [53] 0 0
Vasteras
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London, City Of
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Chelmsford
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Edinburgh
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Leeds
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Liverpool
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Portsmouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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), Analytic code
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.
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.
Available for what types of analyses?
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


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02198651