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Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

NCT00960440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2018-12-19

Study results available
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Summary

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.

DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.

DRUG

Placebo

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.

DRUG

CP-690,550

Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.

DRUG

Placebo

Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.

DRUG

CP-690,550

Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study 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
2009-10-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Ireland
  • Italy
  • Puerto Rico
  • South Korea
  • Spain
  • Taiwan

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 NCT00960440 on ClinicalTrials.gov