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

NCT00814307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2013-01-18

Study results available
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Summary

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.

Conditions

  • Arthritis, Rheumatoid

Interventions

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

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
2009-02-28
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Brazil
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • Dominican Republic
  • Germany
  • India
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • Russia
  • Ukraine

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 NCT00814307 on ClinicalTrials.gov