Clinical trial NCT00687193: Comparison Of 5 CP-690,550 Doses Vs. Placebo, 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 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Phase 2 monotherapy in Japan
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-30
Enrollment: 318
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: To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.


Eligibility criteria: Inclusion Criteria:

* Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion Criteria:

* Current therapy with any DMARD

Primary outcomes:
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8
timeFrame: Week 2, 4, and 8
measure: Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 2, 4, 8 and 12
measure: Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 2, 4, 8 and 12
measure: Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response
timeFrame: Week 2, 4, 8 and 12
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)]
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Painful and Tender Joint Counts
timeFrame: Baseline, Weeks 2, 4, 8 and 12
measure: Change From Baseline in Swollen Joint Count (SJC)
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Patient's Assessment of Pain
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Patient's Global Assessment of Arthritis
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in Physician's Global Assessment of Arthritis
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Change From Baseline in C- Reactive Protein (CRP) (mg/L)
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Euro Quality of Life (EQ-5D)
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS)
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Narashino
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Yotukaidou
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Iiduka
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Sawara-ku
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Higashihiroshima
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Hiroshima-city
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Asahikawa
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Tsukuba
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Koushi
country: Japan
facility: Pfizer Investigational Site
state: Kumamoto
city: Tsu
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Ohmura
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Sasebo
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Kashihara
country: Japan
facility: Pfizer Investigational Site
state: Nara
city: Kawachinagano
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Ureshino-shi
country: Japan
facility: Pfizer Investigational Site
state: Saga
city: Kawagoe-shi
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kitamoto
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Arakawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Musashimurayama-shi
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjyuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Takaoka
country: Japan
facility: Pfizer Investigational Site
state: Toyama
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukusima
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Nagasaki
country: Japan
facility: Pfizer Investigational Site
city: Oita
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Saitama
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: Suzuki M, Shoji S, Miyoshi S, Krishnaswami S. Model-Based Comparison of Dose-Response Profiles of Tofacitinib in Japanese Versus Western Rheumatoid Arthritis Patients. J Clin Pharmacol. 2020 Feb;60(2):198-208. doi: 10.1002/jcph.1514. Epub 2019 Sep 12.
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: Tanaka Y, Takeuchi T, Yamanaka H, Nakamura H, Toyoizumi S, Zwillich S. Efficacy and safety of tofacitinib as monotherapy in Japanese patients with active rheumatoid arthritis: a 12-week, randomized, phase 2 study. Mod Rheumatol. 2015 Jul;25(4):514-21. doi: 10.3109/14397595.2014.995875.
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.