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A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

NCT00856544 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2013-01-10

Study results available
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Summary

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CP-690,550

Film coated tablet, 5 mg PO BID, 1 year

DRUG

CP-690,550

Film coated tablet, 10 mg PO BID, 1 year

DRUG

Placebo

Film coated tablet, 1 tablet PO BID, 3-6 months

DRUG

Placebo

Film coated tablet, 1 tablet PO BID, 3-6 months

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Australia
  • Chile
  • China
  • Colombia
  • Croatia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Malaysia
  • Mexico
  • Poland
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • Thailand
  • United Kingdom
  • Venezuela

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856544 on ClinicalTrials.gov