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

NCT00413660 | Completed Phase 2 Results

• 1 other identifier: A3921025
• Study Type: interventional
• Target: 509
• Locations: 13 countries
• Sites: 82

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Keywords

DMARD therapy

Outcome Measures

Primary Outcomes (1)

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

  ACR20 response: \>= 20% 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 12

Secondary Outcomes (30)

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

  Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)

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

  Week 2, 4, 6, 8, 12, 16, 20, 24/ET

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

  Week 2, 4, 6, 8, 12, 16, 20, 24/ET

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

  Baseline up to Week 2, 4, 6, 8, 12

• Tender Joints Count (TJC)

  Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET

Study Arms (7)

CP 690,550 1 mg BID

EXPERIMENTAL

Drug: CP-690,550

CP 690,550 10 mg BID

EXPERIMENTAL

Drug: CP-690,550

CP 690,550 15 mg

EXPERIMENTAL

Drug: CP-690,550

CP 690,550 3 mg BID

EXPERIMENTAL

Drug: CP-690,550

CP 690,550 5 mg BID

EXPERIMENTAL

Drug: CP-690,550

CP-690,550 20 mg QD

EXPERIMENTAL

Drug: CP-690,550

Placebo

PLACEBO COMPARATOR

Dummy tablets

Other: placebo

Interventions

CP-690,550 DRUG

4 blinded tablets administered BID

CP 690,550 1 mg BID

placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (82)

Pfizer Investigational Site

Gilbert, Arizona, 85234, United States

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Hot Springs, Arkansas, 71913, United States

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Upland, California, 91786, United States

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Denver, Colorado, 80204, United States

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Newark, Delaware, 19713, United States

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DeBary, Florida, 32713, United States

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Lake Mary, Florida, 32746, United States

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Ocala, Florida, 34474, United States

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Orlando, Florida, 32804, United States

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Tampa, Florida, 33614, United States

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Zephyrhills, Florida, 33540, United States

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Rockford, Illinois, 61103-3692, United States

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Rockford, Illinois, 61107, United States

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Dubuque, Iowa, 52002, United States

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Frederick, Maryland, 21702, United States

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Boston, Massachusetts, 02115, United States

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Albany, New York, 12206-1043, United States

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Binghamton, New York, 13905, United States

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Charlotte, North Carolina, 28210, United States

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Raleigh, North Carolina, 27609, United States

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Dayton, Ohio, 45402, United States

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Philladelphia, Pennsylvania, 19118, United States

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West Reading, Pennsylvania, 19611-1124, United States

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Greenville, South Carolina, 29601, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75235, United States

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Mesquite, Texas, 75150, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Tacoma, Washington, 98405-2308, United States

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Tacoma, Washington, 98405, United States

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Onalaska, Wisconsin, 54650, United States

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Capital Federal, Buenos Aires, (C1117ABH), Argentina

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Buenos Aires, C1013AAR, Argentina

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Buenos Aires, C1034ACO, Argentina

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Buenos Aires, C1426ABP, Argentina

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Goiânia, Goiás, 74043-110, Brazil

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Goiânia, Goiás, 74110-120, Brazil

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Curitiba, Paraná, 80060-240, Brazil

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Curitiba, Paraná, 80060-900, Brazil

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São Paulo, São Paulo, 04230-000, Brazil

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São Paulo, São Paulo, 05403-010, Brazil

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Sofia, 1612, Bulgaria

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Sofia, 1709, Bulgaria

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Sofia, Bulgaria

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Viña del Mar, Región de Valparaíso, 2570017, Chile

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Providencia, RM, Chile

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Santiago, RM, 7500922, Chile

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Santiago, Santiago Metropolitan, Chile

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Brno, 656 91, Czechia

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České Budějovice, 370 01, Czechia

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Prague, 128 50, Czechia

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Prague, 140 59, Czechia

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Praha 11 - Chodov, 148 00, Czechia

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Zlín, 760 01, Czechia

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Budapest, H-1036, Hungary

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Komárom, H-2921, Hungary

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Szolnok, H-5000, Hungary

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Veszprém, H-8200, Hungary

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Mexico City, Mexico City, 14000, Mexico

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Morelia, Michoacán, 58070, Mexico

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Bialystok, 15-461, Poland

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Bialystok, 15-950, Poland

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Grudziądz, 86-300, Poland

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Poznan, 60-773, Poland

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Sopot, 81-759, Poland

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Warsaw, 02-256, Poland

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Wroclaw, 50-088, Poland

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Bratislava, 81109, Slovakia

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Piešťany, 921 01, Slovakia

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Žilina, 012 07, Slovakia

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Santiago de Compostela, A Coruña, 15706, Spain

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Guadalajara, Guadalajara, 19002, Spain

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Madrid, Madrid, 28046, Spain

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Seville, Sevilla, 41014, Spain

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Jönköping, 551 85, Sweden

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Umeå, 901 85, Sweden

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Pfizer Investigational Site

Izmir, 35100, Turkey (Türkiye)

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Pfizer Investigational Site

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (15)

• 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.

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• 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.

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• 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.

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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.

  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

• 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.

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• 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: 26275429 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, 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.

  PMID: 22006202 DERIVED

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: December 18, 2006
• First Posted: December 20, 2006
• Study Start: January 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: January 18, 2013
• Results First Posted: January 8, 2013

Record last verified: 2013-01

Locations

TU (4); AR (4); SE (2); CZ (6); ES (4); BU (3); US (33); BR (6); CL (4); HU (4); ME (2); PL (7); SL (3)