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Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

NCT ID: NCT00147498

Last Updated: 2013-01-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-06-30

Brief Summary

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The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).

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Detailed Description

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Conditions

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Rheumatoid Arthritis

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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5 mg BID

CP 690,550 5 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Oral tablets administered at a dose of 5 mg BID for 6 weeks

15 mg BID

CP 690,550 15 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

Oral tablets administered at a dose of 15 mg BID for 6 weeks

30 mg BID

Oral tablets administered at a dose of 30 mg BID for 6 weeks

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

30 mg BID for 6 weeks

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets

Interventions

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CP-690,550

Oral tablets administered at a dose of 5 mg BID for 6 weeks

Intervention Type DRUG

CP-690,550

Oral tablets administered at a dose of 15 mg BID for 6 weeks

Intervention Type DRUG

CP-690,550

30 mg BID for 6 weeks

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion Criteria

* Current Therapy With Any DMARD Or Biologic
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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

Upland, California, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Port Richey, Florida, United States

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Tampa, Florida, United States

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Dubuque, Iowa, United States

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Dubuque, Iowa, United States

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Concord, New Hampshire, United States

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Plainview, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Hickory, North Carolina, United States

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Dayton, Ohio, United States

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Ducansville, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Everett, Washington, United States

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Tacoma, Washington, United States

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Ghent, , Belgium

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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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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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St. John's, Newfoundland and Labrador, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Berlin, , Germany

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Dresden, , Germany

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Hamburg, , Germany

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Hildesheim, , Germany

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Leipzig, , Germany

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München, , Germany

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Neubrandenburg, , Germany

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Wiesbaden, , Germany

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Florence, , Italy

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Genova, , Italy

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Pavia, , Italy

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Aguascalientes, Aguascalientes, Mexico

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México, D.f., Mexico

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Guadalajara, Jalisco, Mexico

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Tlalpan Seccion 16, Mexico City, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Košice, , Slovakia

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Piešťany, , Slovakia

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Žilina, , Slovakia

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Barcelona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Guadalajara, Guadalajara, Spain

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Santiago de Compostela, La Coruña, Spain

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Madrid, Madrid, Spain

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Seville, Sevilla, Spain

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Countries

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United States Belgium Brazil Canada Germany Italy Mexico Slovakia Spain

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)

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, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567.

Reference Type DERIVED
PMID: 19565475 (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=A3921019&StudyName=Three%20Dose%20Levels%20of%20CP-690%2C550%20Monotherapy%20Versus%20Placebo%2C%20Administered%20Orally%20Twice%20Daily%20%28BID%29%20for%206%20Weeks

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

Other Identifiers

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A3921019

Identifier Type: -

Identifier Source: org_study_id

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