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A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

NCT00853385 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 717

Last updated 2013-01-18

Study results available
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Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The 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 on background methotrexate 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 Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Conditions

Interventions

DRUG

CP 690,550

tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

DRUG

CP-690,550

tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

OTHER

Placebo

placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

OTHER

Placebo

tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

BIOLOGICAL

Biologic TNFi

placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 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
2011-03-31
Completion
2011-03-31

Countries

  • United States
  • Australia
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Chile
  • Costa Rica
  • Croatia
  • Czechia
  • Denmark
  • Dominican Republic
  • Finland
  • Germany
  • Mexico
  • Philippines
  • Poland
  • Slovakia
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT00853385 on ClinicalTrials.gov