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A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

NCT00550446 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2013-01-03

Study results available
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Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Adalimumab

40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.

DRUG

CP-690-550

15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

DRUG

CP-690-550

10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

DRUG

CP-690-550

5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)

DRUG

CP-690,550

3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

DRUG

CP-690,550

1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)

DRUG

Placebo

Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

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
2007-09-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • United States
  • Brazil
  • Bulgaria
  • Chile
  • Croatia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Mexico
  • Romania
  • Slovakia
  • South Korea
  • 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 NCT00550446 on ClinicalTrials.gov