Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

NCT00687193 | Completed Phase 2 Results DMC

• 1 other identifier: A3921040
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 40

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.

Conditions

Arthritis, Rheumatoid

Keywords

Phase 2 monotherapy in Japan

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

  ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in painful and tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

  Week 12

Secondary Outcomes (25)

• Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8

  Week 2, 4, and 8

• Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response

  Week 2, 4, 8 and 12

• Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response

  Week 2, 4, 8 and 12

• Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response

  Week 2, 4, 8 and 12

• Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)]

  Baseline, Week 2, 4, 8 and 12

Study Arms (6)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CP-690,550, 10mg

EXPERIMENTAL

Drug: CP-690,550

CP-690,550, 15mg

EXPERIMENTAL

Drug: CP-690,550

CP-690,550, 1mg

EXPERIMENTAL

Drug: CP-690,550

CP-690,550, 3mg

EXPERIMENTAL

Drug: CP-690,550

CP-690,550, 5mg

EXPERIMENTAL

Drug: CP-690,550

Interventions

Placebo DRUG

Placebo BID, 3 blinded tablets administered BID for 12 weeks

Placebo

CP-690,550 DRUG

10mg BID, 3 blinded tablets administered BID for 12 weeks

CP-690,550, 10mg

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current therapy with any DMARD

Sponsors & Collaborators

• Pfizer: lead

Study Sites (40)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Chiba, Chiba, Japan

Location

Pfizer Investigational Site

Narashino, Chiba, Japan

Location

Pfizer Investigational Site

Yotukaidou, Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Iiduka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Kurume, Fukuoka, Japan

Location

Pfizer Investigational Site

Sawara-ku, Fukuoka, Japan

Location

Pfizer Investigational Site

Fukushima, Fukushima, Japan

Location

Pfizer Investigational Site

Takasaki, Gunma, Japan

Location

Pfizer Investigational Site

Higashihiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Nishinomiya, Hyōgo, Japan

Location

Pfizer Investigational Site

Tsukuba, Ibaraki, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Location

Pfizer Investigational Site

Koushi, Kumamoto, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, Japan

Location

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Nagasaki, Nagasaki, Japan

Location

Pfizer Investigational Site

Ohmura, Nagasaki, Japan

Location

Pfizer Investigational Site

Sasebo, Nagasaki, Japan

Location

Pfizer Investigational Site

Kashihara, Nara, Japan

Location

Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

Location

Pfizer Investigational Site

Kawachi-Nagano, Osaka, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Ureshino-shi, Saga-ken, Japan

Location

Pfizer Investigational Site

Kawagoe-shi, Saitama, Japan

Location

Pfizer Investigational Site

Kitamoto, Saitama, Japan

Location

Pfizer Investigational Site

Saitama, Saitama, Japan

Location

Pfizer Investigational Site

Arakawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Musashimurayama-shi, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Takaoka, Toyama, Japan

Location

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• Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.

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• Hansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.

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• Curtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.

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• Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 30, 2008
• Study Start: March 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 25, 2013
• Results First Posted: December 25, 2012

Record last verified: 2013-03

Locations

JP (40)