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A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The patient has a diagnosis of RA based upon the American College of Rheumatology
(ACR) 1987 Revised Criteria.

- The patient has active disease at both Screening and Baseline, as defined by both: ≥6
joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the
following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local
laboratory. 2. CRP >7 mg/L in the central laboratory

- Patient had an inadequate response to at least one DMARD (traditional or biologic) due
to lack of efficacy or toxicity.

- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis.

- Patient has washed out of all DMARDs other that antimalarials

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Blood dyscrasias including confirmed: 1. Hemoglobin White blood cell count Platelet count

- History of any other autoimmune rheumatic disease other than Sjogren's syndrome

- No malignancy or history of malignancy.

- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug

NCT00814307
Pfizer
Completed
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

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A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: CP-690,550
    5mg CP-690,550 BID PO for 6 months
  • Drug: CP-690,550
    10 mg CP-690,550 BID PO for 6 months
  • Drug: Placebo
    Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
  • Drug: Placebo
    Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
  • Experimental: Active 5mg
    Intervention: Drug: CP-690,550
  • Experimental: Active 10 mg
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo Sequence 1
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo Sequence 2
    Intervention: Drug: Placebo


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
611
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
  • The patient has active disease at both Screening and Baseline, as defined by both: ?6 joints tender or painful on motion; and ?6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory
  • Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
  • Patient has washed out of all DMARDs other that antimalarials

Exclusion Criteria:

  • Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
  • History of any other autoimmune rheumatic disease other than Sjogren's syndrome
  • No malignancy or history of malignancy.
  • History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Bulgaria,   Chile,   Colombia,   Czech Republic,   Dominican Republic,   Germany,   India,   Malaysia,   Mexico,   Philippines,   Poland,   Puerto Rico,   Russian Federation,   Ukraine,   United States
 
 
NCT00814307
A3921045
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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