Clinical trial NCT00147498: Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: oral JAK inhibitor
clinical trial
joint diseases
anti-Inflammatory agents
rheumatic diseases
DMARD
Antirheumatic Agents
Autoimmune Diseases
Immune System Diseases
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-07
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 1, 2, 4, and 8
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 1, 2, 4, 6, and 8
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 1, 2, 4, 6, and 8
measure: Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve
timeFrame: Baseline up to Week 6
measure: Tender Joints Count (TJC)
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Tender Joints Count (TJC) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Swollen Joints Count (SJC)
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Swollen Joints Count (SJC) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Patient Global Assessment (PtGA) of Arthritis
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Physician Global Assessment of Arthritis
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Physician Global Assessment of Arthritis at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Patient Assessment of Arthritis Pain
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Patient Assessment of Arthritis Pain at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 6 and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Change From Baseline in Disease Activity Score Using 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 6, and 8
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
measure: Number of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)
timeFrame: Baseline, Week 1, 2, 4, 6, and 8
Other outcomes:
Locations:
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Dubuque
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Concord
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Plainview
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Ducansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Saint John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hildesheim
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Neubrandenburg
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: México
country: Mexico
facility: Pfizer Investigational Site
state: D.f.
city: Tlalpan Seccion 16
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Aguascalientes
country: Mexico
facility: Pfizer Investigational Site
city: San Luis Potosí
country: Mexico
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: L´hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Guadalajara
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.