CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 386 enrolled
Drug / intervention
Adalimumab +6 moredrug
Likely dose
Adalimumab 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00550446
NCT00550446Phase 2Completed
CompareCT.gov

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Pfizer·interventional·Posted Oct 29, 2007·Updated Jan 3, 2013

In Brief

A Phase 2 clinical trial evaluating Adalimumab, CP-690-550, and 2 other interventions for Arthritis, Rheumatoid. Completed, enrolled 386 participants across 63 sites in 15 countries.

Detailed 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.)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBrazil, Bulgaria, Chile, Croatia, Czechia, Germany, Greece, Hungary, Italy, Mexico, Romania, Slovakia, South Korea, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 29, 2007
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.7 years ago

Interventions

Adalimumabdrug

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.

CP-690-550drug

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

CP-690-550drug

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

CP-690-550drug

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

CP-690,550drug

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

CP-690,550drug

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

Placebodrug

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