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A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

NCT00847613 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-05-16

Study results available
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Summary

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

DRUG

Placebo

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

DRUG

Placebo

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

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
2009-03-31
Primary Completion
2011-04-30
Completion
2012-02-29

Countries

  • United States
  • Australia
  • Brazil
  • Bulgaria
  • Canada
  • Colombia
  • Czechia
  • Greece
  • India
  • Japan
  • Mexico
  • Poland
  • South Korea
  • Taiwan
  • 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 NCT00847613 on ClinicalTrials.gov