Clinical trial NCT00603512: Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Phase II MTX add-on study in Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-29
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria:

* Current therapy with any DMARD or biologic other than methotrexate

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 1, 2, 4, 8
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 1, 2, 4, 8, 12/End of Treatment (EOT)
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 1, 2, 4, 8, 12/EOT
measure: Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response
timeFrame: Week 1, 2, 4, 8, 12/EOT
measure: Tender Joint Count (TJC)
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Tender Joint Count (TJC) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Swollen Joint Count (SJC)
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Patient Assessment of Arthritis Pain
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Patient Global Assessment (PtGA) of Arthritis
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Patient Global Assessment of Arthritis (PtGA) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Physician Global Assessment (PGA) of Arthritis
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Physician Global Assessment of Arthritis (PGA) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12/EOT
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Numeric Index of American College of Rheumatology Response (ACR-n)
timeFrame: Week 1, 2, 4, 8, 12/EOT
measure: Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
timeFrame: Baseline up to Week 12
measure: Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Baseline, Week 1, 2, 4, 8, 12/EOT
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, Week 12/EOT
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline, Week 12/EOT
measure: Medical Outcome Study- Sleep Scale (MOS-SS)
timeFrame: Baseline, Week 2, 12/EOT
measure: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
timeFrame: Baseline, Week 2, 12/EOT
Other outcomes:
Locations:
city: Hitachi-shi
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yahatanishi-ku
country: Japan
facility: Pfizer Investigational Site
state: Kitakyusyu
city: Koushi
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Kawachinagano
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kitamoto
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Bunkyo-k
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashimurayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Niigata
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
citation: 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.
citation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
citation: Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14.
citation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.