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

NCT00147498 | Completed Phase 2 Results

• 1 other identifier: A3921019
• Study Type: interventional
• Target: 264
• Locations: 9 countries
• Sites: 60

Brief Summary

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).

Conditions

Rheumatoid Arthritis

Keywords

oral JAK inhibitor; clinical trial; joint diseases; anti-Inflammatory agents; rheumatic diseases; DMARD; Antirheumatic Agents; Autoimmune Diseases; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6

  ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints 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 6

Secondary Outcomes (21)

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

  Week 1, 2, 4, and 8

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

  Week 1, 2, 4, 6, and 8

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

  Week 1, 2, 4, 6, and 8

• Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve

  Baseline up to Week 6

• Tender Joints Count (TJC)

  Baseline, Week 1, 2, 4, 6, and 8

Study Arms (4)

5 mg BID

EXPERIMENTAL

CP 690,550 5 mg BID

Drug: CP-690,550

15 mg BID

EXPERIMENTAL

CP 690,550 15 mg BID

Drug: CP-690,550

30 mg BID

EXPERIMENTAL

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

Drug: CP-690,550

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CP-690,550 DRUG

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

5 mg BID

Placebo OTHER

Placebo tablets

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Current Therapy With Any DMARD Or Biologic

Sponsors & Collaborators

• Pfizer: lead

Study Sites (60)

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33765, United States

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Pfizer Investigational Site

Miami, Florida, 33173, United States

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New Port Richey, Florida, 34652, United States

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Pfizer Investigational Site

Ocala, Florida, 34474-7455, United States

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Pfizer Investigational Site

Orlando, Florida, 32804, United States

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Pfizer Investigational Site

Port Richey, Florida, 34668, United States

Location

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Tampa, Florida, 33614, United States

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Pfizer Investigational Site

Dubuque, Iowa, 52001-7313, United States

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Pfizer Investigational Site

Dubuque, Iowa, 52002, United States

Location

Pfizer Investigational Site

Concord, New Hampshire, 03301, United States

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Pfizer Investigational Site

Plainview, New York, 11803, United States

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Charlotte, North Carolina, 28210, United States

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Hickory, North Carolina, 28601, United States

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Hickory, North Carolina, 28602, United States

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Dayton, Ohio, 45402, United States

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Ducansville, Pennsylvania, 16635, United States

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Johnstown, Pennsylvania, 15904, United States

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Charleston, South Carolina, 29406, United States

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Columbia, South Carolina, 29204, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75231-4496, United States

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Everett, Washington, 98201, United States

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Tacoma, Washington, 98405, United States

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Ghent, 9000, Belgium

Location

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Goiânia, Goiás, 74043-110, Brazil

Location

Pfizer Investigational Site

Goiânia, Goiás, 74110-120, Brazil

Location

Pfizer Investigational Site

Curitiba, Paraná, 80060-240, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, 04230-000, Brazil

Location

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São Paulo, São Paulo, 05001-000, Brazil

Location

Pfizer Investigational Site

Edmonton, Alberta, T5M 0H4, Canada

Location

Pfizer Investigational Site

Victoria, British Columbia, V8P 5P6, Canada

Location

Pfizer Investigational Site

St. John's, Newfoundland and Labrador, A1C 5B8, Canada

Location

Pfizer Investigational Site

London, Ontario, N6A 4V2, Canada

Location

Pfizer Investigational Site

Toronto, Ontario, M5T 2S8, Canada

Location

Pfizer Investigational Site

Berlin, 10098, Germany

Location

Pfizer Investigational Site

Dresden, 01067, Germany

Location

Pfizer Investigational Site

Hamburg, 22081, Germany

Location

Pfizer Investigational Site

Hildesheim, 31134, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

München, 80639, Germany

Location

Pfizer Investigational Site

Neubrandenburg, 17033, Germany

Location

Pfizer Investigational Site

Wiesbaden, 65191, Germany

Location

Pfizer Investigational Site

Florence, 50139, Italy

Location

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Genova, 16132, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

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Aguascalientes, Aguascalientes, 20230, Mexico

Location

Pfizer Investigational Site

México, D.f., 06726, Mexico

Location

Pfizer Investigational Site

Guadalajara, Jalisco, 44690, Mexico

Location

Pfizer Investigational Site

Tlalpan Seccion 16, Mexico City, 14000, Mexico

Location

Pfizer Investigational Site

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Pfizer Investigational Site

Košice, 040 11, Slovakia

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Pfizer Investigational Site

Piešťany, 921 01, Slovakia

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Pfizer Investigational Site

Žilina, 012 07, Slovakia

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08003, Spain

Location

Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Guadalajara, Guadalajara, 19002, Spain

Location

Pfizer Investigational Site

Santiago de Compostela, La Coruña, 15706, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28046, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41014, Spain

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: 39192350 DERIVED

• 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: 38958913 DERIVED

• 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: 36931693 DERIVED

• 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: 36601090 DERIVED

• 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: 36600185 DERIVED

• 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: 36526796 DERIVED

• 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: 34870800 DERIVED

• 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: 33127856 DERIVED

• 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: 32816215 DERIVED

• 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: 28941219 DERIVED

• 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: 28143815 DERIVED

• 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: 25047021 DERIVED

• 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.

  PMID: 19565475 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Joint Diseases; Rheumatic Diseases; Autoimmune Diseases; Immune System Diseases

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue 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: September 2, 2005
• First Posted: September 7, 2005
• Study Start: January 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 30, 2013
• Results First Posted: January 30, 2013

Record last verified: 2012-12

Locations

IT (3); SL (3); BE (1); DE (8); BR (5); CA (5); ES (6); ME (5); US (24)