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Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

NCT ID: NCT00413660

Last Updated: 2013-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

509 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

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Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CP 690,550 1 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

4 blinded tablets administered BID

CP 690,550 10 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

4 blinded tablets administered BID

CP 690,550 15 mg

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

4 blinded tablets administered BID

CP 690,550 3 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

4 blinded tablets administered BID

CP 690,550 5 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

4 blinded tablets administered BID

CP-690,550 20 mg QD

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Oral tablets

Placebo

Dummy tablets

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Placebo

Interventions

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CP-690,550

4 blinded tablets administered BID

Intervention Type DRUG

CP-690,550

4 blinded tablets administered BID

Intervention Type DRUG

CP-690,550

4 blinded tablets administered BID

Intervention Type DRUG

CP-690,550

4 blinded tablets administered BID

Intervention Type DRUG

CP-690,550

4 blinded tablets administered BID

Intervention Type DRUG

CP-690,550

Oral tablets

Intervention Type DRUG

placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Active rheumatoid arthritis
* Inadequate response to stably dosed methotrexate

Exclusion Criteria

* Current therapy with any DMARD or biologic other than methotrexate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Gilbert, Arizona, United States

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Hot Springs, Arkansas, United States

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Upland, California, United States

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Denver, Colorado, United States

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Newark, Delaware, United States

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DeBary, Florida, United States

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Lake Mary, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Zephyrhills, Florida, United States

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Rockford, Illinois, United States

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Rockford, Illinois, United States

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Dubuque, Iowa, United States

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Frederick, Maryland, United States

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Boston, Massachusetts, United States

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Albany, New York, United States

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Binghamton, New York, United States

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Charlotte, North Carolina, United States

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Raleigh, North Carolina, United States

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Dayton, Ohio, United States

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Philladelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Greenville, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Mesquite, Texas, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Onalaska, Wisconsin, United States

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Capital Federal, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Goiânia, Goiás, Brazil

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Goiânia, Goiás, Brazil

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Curitiba, Paraná, Brazil

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Curitiba, Paraná, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Viña del Mar, Región de Valparaíso, Chile

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Providencia, RM, Chile

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Santiago, RM, Chile

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Santiago, Santiago Metropolitan, Chile

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Brno, , Czechia

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České Budějovice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Praha 11 - Chodov, , Czechia

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Zlín, , Czechia

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Budapest, , Hungary

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Komárom, , Hungary

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Szolnok, , Hungary

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Veszprém, , Hungary

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Mexico City, Mexico City, Mexico

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Morelia, Michoacán, Mexico

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Bialystok, , Poland

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Bialystok, , Poland

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Grudziądz, , Poland

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Poznan, , Poland

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Sopot, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bratislava, , Slovakia

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Piešťany, , Slovakia

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Žilina, , Slovakia

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Santiago de Compostela, A Coruña, Spain

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Guadalajara, Guadalajara, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Jönköping, , Sweden

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Umeå, , Sweden

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Countries

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United States Argentina Brazil Bulgaria Chile Czechia Hungary Mexico Poland Slovakia Spain Sweden Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 39192350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38958913 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36931693 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36601090 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36600185 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36526796 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34870800 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33127856 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32816215 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28941219 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28143815 (View on PubMed)

Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH. Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials. Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.

Reference Type DERIVED
PMID: 27156561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26275429 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25047021 (View on PubMed)

Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, Kanik KS, Krishnaswami S, Pascual-Ramos V, Wallenstein G, Zwillich SH. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012 Apr;64(4):970-81. doi: 10.1002/art.33419. Epub 2011 Oct 17.

Reference Type DERIVED
PMID: 22006202 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921025&StudyName=Comparison%20Of%206%20CP-690%2C550%20Doses%20Vs.Placebo%2C%20Each%20Combined%20With%20Methotrexate%2C%20For%20The%20Treatment%20Of%20Rheumatoid%20Arthritis

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

Other Identifiers

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A3921025

Identifier Type: -

Identifier Source: org_study_id

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