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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01877668




Registration number
NCT01877668
Ethics application status
Date submitted
12/06/2013
Date registered
14/06/2013
Date last updated
6/07/2017

Titles & IDs
Public title
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
Secondary ID [1] 0 0
2011-003668-55
Secondary ID [2] 0 0
A3921091
Universal Trial Number (UTN)
Trial acronym
OPAL BROADEN
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 5 mg BID
Treatment: Drugs - Tofacitinib 10 mg BID
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: Tofacitinib 5 mgBID x 12 months -

Experimental: Tofacitinib 10 mg BID x 12 months -

Active comparator: Adalimumab 40 mg q2 weeks x 12 months -

Placebo comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months -

Placebo comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months -


Treatment: Drugs: Tofacitinib 5 mg BID
Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months

Treatment: Drugs: Tofacitinib 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months

Treatment: Drugs: Adalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months

Treatment: Drugs: Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months

Treatment: Drugs: Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =20% (ACR20): Month 3
Timepoint [1] 0 0
At end of Month 3
Primary outcome [2] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Timepoint [2] 0 0
From Baseline to Month 3
Secondary outcome [1] 0 0
Change From Baseline in the Van Der Heijdel Modified Total Sharp Score (mTSS) for Psoriatic Arthritis
Timepoint [1] 0 0
From Baseline to Month 12
Secondary outcome [2] 0 0
Percentage of Participants With Progressed Modified Total Sharp Score (mTSS) at Month 12
Timepoint [2] 0 0
At Month 12
Secondary outcome [3] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =50% (ACR50) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Timepoint [3] 0 0
At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Secondary outcome [4] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =70% (ACR70) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Timepoint [4] 0 0
At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Secondary outcome [5] 0 0
Percentage of Participants Meeting American College of Rheumatology Response Criteria =20% (ACR20) at Week 2 and Months 1, 2, 4, 6, 9, and 12
Timepoint [5] 0 0
At Week 2 and Months 1, 2, 4, 6, 9, and 12
Secondary outcome [6] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Timepoint [6] 0 0
From Baseline to Week 2 and Months 1, 2, 4, 6, 9, and 12
Secondary outcome [7] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components: C-reactive Protein Levels
Timepoint [7] 0 0
From Baseline to end of Month 3
Secondary outcome [8] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Assessment of Arthritis Pain
Timepoint [8] 0 0
From Baseline to end of Month 3
Secondary outcome [9] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Patient's Global Assessment of Arthritis
Timepoint [9] 0 0
From Baseline to end of Month 3
Secondary outcome [10] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Physician's Global Assessment of Arthritis
Timepoint [10] 0 0
From Baseline to end of Month 3
Secondary outcome [11] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Swollen Joint Count
Timepoint [11] 0 0
From Baseline to end of Month 3
Secondary outcome [12] 0 0
Change From Baseline in American College of Rheumatology Response Criteria Components Score: Tender/Painful Joint Count
Timepoint [12] 0 0
From Baseline to end of Month 3
Secondary outcome [13] 0 0
Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC) at Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Timepoint [13] 0 0
At Week 2 and Months 1, 2, 3, 4, 6, 9, and 12
Secondary outcome [14] 0 0
Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response
Timepoint [14] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [15] 0 0
Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Months 1, 3, 6, 9, and 12
Timepoint [15] 0 0
At Months 1, 3, 6, 9, and 12
Secondary outcome [16] 0 0
Change From Baseline in Dactylitis Severity Score (DSS)
Timepoint [16] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [17] 0 0
Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Timepoint [17] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [18] 0 0
Change From Baseline in the Leeds Enthesitis Index (LEI)
Timepoint [18] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [19] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2) Acute, Physical Component Summary Score
Timepoint [19] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [20] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute, Mental Component Summary Score
Timepoint [20] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [21] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Physical Functioning Domain
Timepoint [21] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [22] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Physical Domain
Timepoint [22] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [23] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Bodily Pain Domain
Timepoint [23] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [24] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: General Health Domain
Timepoint [24] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [25] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Vitality Domain
Timepoint [25] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [26] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Social Functioning Domain
Timepoint [26] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [27] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Role-Emotional Domain
Timepoint [27] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [28] 0 0
Change From Baseline in the Short-Form-36 Health Survey Version 2 (SF-36v2), Acute Components: Mental Health Domain
Timepoint [28] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
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): Mobility
Timepoint [29] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
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): Self-care
Timepoint [30] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
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): Usual Activities
Timepoint [31] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
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 a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort
Timepoint [32] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [33] 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
Timepoint [33] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [34] 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): Patient's Health State Today
Timepoint [34] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [35] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score
Timepoint [35] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [36] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score
Timepoint [36] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [37] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score
Timepoint [37] 0 0
From Baseline to Months 1, 3, 6, 9, and 12
Secondary outcome [38] 0 0
Change From Baseline in Scores Evaluating Spondylitis Using the Bath Anklyosing Spondylitis Disease Activity Index (BASDAI)
Timepoint [38] 0 0
From Baseline to Months 1, 3, 6, 9, and 12

Eligibility
Key inclusion criteria
* Males or females, aged >= 18 years at time of consent.
* Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
* Meet the Classification Criteria of PsA (CASPAR) at time of screening
* Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
* Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
* Must not have taken a biologic Tumour Necrosis Factor Inhibitor
* Must have 3 or more swollen joints AND 3 or more tender joints
* Must have active psoriasis skin lesions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
* Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
* New York Heart Association Class III and IV congestive heart failure
* History of hypersensitivity or infusion reaction to biologic agents
* Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

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 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
20/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/12/2015
Sample size
Target
Accrual to date
Final
422
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Rheumatology Research Unit - Maroochydore
Recruitment hospital [2] 0 0
Pacific Private Clinic - Southport
Recruitment hospital [3] 0 0
Monash Health, Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Pharmacy Clinical Trials - Clayton
Recruitment hospital [5] 0 0
St. Vincent's Hospital (Melbourne) - Fitzroy
Recruitment hospital [6] 0 0
Emeritus Research Pty Ltd - Malvern East
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Nebraska
Country [9] 0 0
United States of America
State/province [9] 0 0
New Hampshire
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Belgium
State/province [16] 0 0
Brussels
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Pleven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Plovdiv
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sofia
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Stara Zagora
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
Czechia
State/province [25] 0 0
Czech Republic
Country [26] 0 0
Czechia
State/province [26] 0 0
Brno
Country [27] 0 0
Czechia
State/province [27] 0 0
Ostrava
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 1- Nove Mesto
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 2
Country [30] 0 0
Czechia
State/province [30] 0 0
Uherske Hradiste
Country [31] 0 0
France
State/province [31] 0 0
Corbeil Essonnes cedex
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Koeln
Country [34] 0 0
Germany
State/province [34] 0 0
Schwerin
Country [35] 0 0
Hungary
State/province [35] 0 0
Budapest
Country [36] 0 0
Hungary
State/province [36] 0 0
Veszprem
Country [37] 0 0
Mexico
State/province [37] 0 0
Jalisco
Country [38] 0 0
Mexico
State/province [38] 0 0
Sinaloa
Country [39] 0 0
Mexico
State/province [39] 0 0
Yucatan
Country [40] 0 0
Mexico
State/province [40] 0 0
Chihuahua
Country [41] 0 0
Mexico
State/province [41] 0 0
Mexico City
Country [42] 0 0
Poland
State/province [42] 0 0
Bialystok
Country [43] 0 0
Poland
State/province [43] 0 0
Bydgoszcz
Country [44] 0 0
Poland
State/province [44] 0 0
Elblag
Country [45] 0 0
Poland
State/province [45] 0 0
Grodzisk Mazowiecki
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Nadarzyn
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Torun
Country [50] 0 0
Poland
State/province [50] 0 0
Warsaw
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Poland
State/province [52] 0 0
Wroclaw
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Karelia Republic
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Moscow
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Novosibirsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saratov
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Tomsk
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Yaroslavl
Country [59] 0 0
Slovakia
State/province [59] 0 0
Slovak Republic
Country [60] 0 0
Slovakia
State/province [60] 0 0
Bratislava
Country [61] 0 0
Slovakia
State/province [61] 0 0
Rimavska Sobota
Country [62] 0 0
Spain
State/province [62] 0 0
A Coruna
Country [63] 0 0
Spain
State/province [63] 0 0
Barcelona
Country [64] 0 0
Spain
State/province [64] 0 0
Cantabria
Country [65] 0 0
Spain
State/province [65] 0 0
Sevilla
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taiwan Roc
Country [68] 0 0
Taiwan
State/province [68] 0 0
Chia-Yi
Country [69] 0 0
Taiwan
State/province [69] 0 0
Kaohsiung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taichung
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Essex
Country [72] 0 0
United Kingdom
State/province [72] 0 0
West Midlands
Country [73] 0 0
United Kingdom
State/province [73] 0 0
West Yorkshire
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Wirral
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
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Trial website
https://clinicaltrials.gov/study/NCT01877668
Trial related presentations / publications
de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.
Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.
Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.
Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.
Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.
de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.
Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.
Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2021 Sep;66(9):3214-3215. doi: 10.1007/s10620-020-06638-z.
Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01877668