NCT00603512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

January 25, 2013

Completed
Last Updated

January 25, 2013

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

January 17, 2008

Results QC Date

November 14, 2012

Last Update Submit

December 16, 2012

Conditions

Arthritis, Rheumatoid

Keywords

Phase II MTX add-on study in Japan

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

    ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); 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 (26)

  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

    Week 1, 2, 4, 8

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

    Week 1, 2, 4, 8, 12/End of Treatment (EOT)

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

    Week 1, 2, 4, 8, 12/EOT

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

    Week 1, 2, 4, 8, 12/EOT

  • Tender Joint Count (TJC)

    Baseline, Week 1, 2, 4, 8, 12/EOT

  • +21 more secondary outcomes

Study Arms (5)

CP-690,550, 0mg

PLACEBO COMPARATOR
Drug: Placebo

CP-690,550, 10mg

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

PlaceboDRUG

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

CP-690,550, 0mg
CP-690,550DRUG

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

CP-690,550, 10mg

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active rheumatoid arthritis
  • Inadequate response to stably dosed methotrexate

You may not qualify if:

  • Current therapy with any DMARD or biologic other than methotrexate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Pfizer Investigational Site

Chiba, Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Hitachi-shi, Ibaraki, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Location

Pfizer Investigational Site

Yahatanishi-ku, Kitakyusyu, Japan

Location

Pfizer Investigational Site

Koushi, Kumamoto, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Niigata, Niigata, Japan

Location

Pfizer Investigational Site

Kawachi-Nagano, Osaka, Japan

Location

Pfizer Investigational Site

Kawagoe-shi, Saitama, Japan

Location

Pfizer Investigational Site

Kitamoto, Saitama, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Bunkyo-k, Tokyo, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Koto-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Musashimurayama-shi, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

Related Publications (13)

  • Hetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.

    PMID: 39192350DERIVED

  • Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.

    PMID: 38958913DERIVED

  • Kristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.

    PMID: 36931693DERIVED

  • 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.

    PMID: 36601090DERIVED

  • 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.

    PMID: 36600185DERIVED

  • 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.

    PMID: 36526796DERIVED

  • 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.

    PMID: 34870800DERIVED

  • 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.

    PMID: 33127856DERIVED

  • 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.

    PMID: 32816215DERIVED

  • 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.

    PMID: 28941219DERIVED

  • 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.

    PMID: 28143815DERIVED

  • 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.

    PMID: 26275429DERIVED

  • 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.

    PMID: 25047021DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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

January 17, 2008

First Posted

January 29, 2008

Study Start

January 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 25, 2013

Results First Posted

January 25, 2013

Record last verified: 2012-12

Locations

JP(18)