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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01882439




Registration number
NCT01882439
Ethics application status
Date submitted
18/06/2013
Date registered
20/06/2013
Date last updated
15/09/2017

Titles & IDs
Public title
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
Secondary ID [1] 0 0
2013-001368-46
Secondary ID [2] 0 0
A3921125
Universal Trial Number (UTN)
Trial acronym
OPAL BEYOND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

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

Experimental: Treatment Sequence A - Tofacitinib 5 mg BID for 6 months

Experimental: Treatment Sequence B - Tofacitinib 10 mg BID for 6 months

Placebo comparator: Treatment Sequence C - Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Placebo comparator: Treatment Sequence D - Placebo for 3 months then tofacitinib 10 mg BID for 3 months


Treatment: Drugs: Tofacitinib
tablets, 5 mg BID x 6 months

Treatment: Drugs: Tofacitinib
tablets, 10 mg BID x 6 months

Other interventions: Placebo
tablets, to match tofacitinib 5 mg BID x 3 months

Treatment: Drugs: Tofacitinib
tablets, 5 mg BID x 3 months

Other interventions: Placebo
tablets, to match tofacitinib 10 mg BID x 3 months

Treatment: Drugs: Tofacitinib
tablets, 10 mg BID x 3 months
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (=) 20% (ACR20): Month 3
Timepoint [1] 0 0
Month 3
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3
Timepoint [2] 0 0
Month 3
Secondary outcome [1] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6
Timepoint [1] 0 0
Week 2 and Months 1, 2, 3, 4, and 6
Secondary outcome [2] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6
Timepoint [2] 0 0
Week 2 and Months 1, 2, 3, 4, and 6
Secondary outcome [3] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (=) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6
Timepoint [3] 0 0
Week 2 and Months 1, 2, 4, and 6
Secondary outcome [4] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6
Timepoint [4] 0 0
Week 2 and Months 1, 2, 4, and 6
Secondary outcome [5] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3
Timepoint [5] 0 0
Month 3
Secondary outcome [6] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3
Timepoint [6] 0 0
Month 3
Secondary outcome [7] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3
Timepoint [7] 0 0
Month 3
Secondary outcome [8] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3
Timepoint [8] 0 0
Month 3
Secondary outcome [9] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3
Timepoint [9] 0 0
Month 3
Secondary outcome [10] 0 0
Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3
Timepoint [10] 0 0
Month 3
Secondary outcome [11] 0 0
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6
Timepoint [11] 0 0
Week 2, Months 1, 2, 3, 4, and 6
Secondary outcome [12] 0 0
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6
Timepoint [12] 0 0
Months 1, 3, and 6
Secondary outcome [13] 0 0
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6
Timepoint [13] 0 0
Months 1, 3, and 6
Secondary outcome [14] 0 0
Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6
Timepoint [14] 0 0
Months 1, 3, and 6
Secondary outcome [15] 0 0
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6
Timepoint [15] 0 0
Months 1, 3, and 6
Secondary outcome [16] 0 0
Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6
Timepoint [16] 0 0
Months 1, 3, and 6
Secondary outcome [17] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6
Timepoint [17] 0 0
Months 1, 3, 6
Secondary outcome [18] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6
Timepoint [18] 0 0
Months 1, 3, 6
Secondary outcome [19] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6
Timepoint [19] 0 0
Months 1, 3, 6
Secondary outcome [20] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6
Timepoint [20] 0 0
Months 1, 3, 6
Secondary outcome [21] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6
Timepoint [21] 0 0
Months 1, 3, 6
Secondary outcome [22] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6
Timepoint [22] 0 0
Months 1, 3, 6
Secondary outcome [23] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6
Timepoint [23] 0 0
Months 1, 3, 6
Secondary outcome [24] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6
Timepoint [24] 0 0
Months 1, 3, 6
Secondary outcome [25] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6
Timepoint [25] 0 0
Months 1, 3, 6
Secondary outcome [26] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6
Timepoint [26] 0 0
Months 1, 3, 6
Secondary outcome [27] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6
Timepoint [27] 0 0
Months 1, 3, 6
Secondary outcome [28] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6
Timepoint [28] 0 0
Months 1, 3, 6
Secondary outcome [29] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6
Timepoint [29] 0 0
Months 1, 3, 6
Secondary outcome [30] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6
Timepoint [30] 0 0
Months 1, 3, 6
Secondary outcome [31] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6
Timepoint [31] 0 0
Months 1, 3, 6
Secondary outcome [32] 0 0
Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6
Timepoint [32] 0 0
Months 1, 3, 6
Secondary outcome [33] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6
Timepoint [33] 0 0
Months 1, 3, 6
Secondary outcome [34] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6
Timepoint [34] 0 0
Months 1, 3, 6
Secondary outcome [35] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6
Timepoint [35] 0 0
Months 1, 3, 6
Secondary outcome [36] 0 0
Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6
Timepoint [36] 0 0
Months 1, 3, 6

Eligibility
Key inclusion criteria
* Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
* Active plaque psoriasis at screening
* Inadequate efficacy or lack of toleration to previously administered TNF inhibitor
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-plaque forms of psoriasis (with exception of nail psoriasis)
* History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
395
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Rheumatology Department - Camperdown
Recruitment hospital [2] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [3] 0 0
Emeritus Research Pty Ltd - Malvern East
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
3145 - Malvern East
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
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
New Hampshire
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
South Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Genk
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Belgium
State/province [25] 0 0
Merksem
Country [26] 0 0
Brazil
State/province [26] 0 0
MG
Country [27] 0 0
Brazil
State/province [27] 0 0
PR
Country [28] 0 0
Brazil
State/province [28] 0 0
RS
Country [29] 0 0
Brazil
State/province [29] 0 0
SP
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Czechia
State/province [31] 0 0
Uherske Hradiste
Country [32] 0 0
France
State/province [32] 0 0
Cedex
Country [33] 0 0
France
State/province [33] 0 0
Bobigny
Country [34] 0 0
Germany
State/province [34] 0 0
Bad Doberan
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
Erlangen
Country [37] 0 0
Germany
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Frankfurt am Main
Country [38] 0 0
Germany
State/province [38] 0 0
Freiburg
Country [39] 0 0
Germany
State/province [39] 0 0
Homburg
Country [40] 0 0
Germany
State/province [40] 0 0
Koeln
Country [41] 0 0
Germany
State/province [41] 0 0
Olsberg
Country [42] 0 0
Mexico
State/province [42] 0 0
D.F
Country [43] 0 0
Mexico
State/province [43] 0 0
Distrito Federal
Country [44] 0 0
Mexico
State/province [44] 0 0
Jalisco
Country [45] 0 0
Mexico
State/province [45] 0 0
Sinaloa
Country [46] 0 0
Mexico
State/province [46] 0 0
Yucatan
Country [47] 0 0
Mexico
State/province [47] 0 0
Chihuahua
Country [48] 0 0
Poland
State/province [48] 0 0
Elblag
Country [49] 0 0
Poland
State/province [49] 0 0
Grodzisk Mazowiecki
Country [50] 0 0
Poland
State/province [50] 0 0
Lodz
Country [51] 0 0
Poland
State/province [51] 0 0
Nadarzyn
Country [52] 0 0
Poland
State/province [52] 0 0
Poznan
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Karelia Republic
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Republic of Tatarstan, Russia
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Moscow
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Novosibirsk
Country [58] 0 0
Russian Federation
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Tomsk
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Russian Federation
State/province [59] 0 0
Yaroslavl
Country [60] 0 0
Slovakia
State/province [60] 0 0
Martin
Country [61] 0 0
Spain
State/province [61] 0 0
A Coruna
Country [62] 0 0
Spain
State/province [62] 0 0
Barcelona
Country [63] 0 0
Spain
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Cantabria
Country [64] 0 0
Spain
State/province [64] 0 0
Sevilla
Country [65] 0 0
Spain
State/province [65] 0 0
Valencia
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taiwan Roc
Country [67] 0 0
Taiwan
State/province [67] 0 0
Chia-Yi
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung City
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Essex
Country [71] 0 0
United Kingdom
State/province [71] 0 0
West Midlands
Country [72] 0 0
United Kingdom
State/province [72] 0 0
West Yorkeshire
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Bath
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Bradford
Country [75] 0 0
United Kingdom
State/province [75] 0 0
York

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01882439