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

Phase 2 Completed 386 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

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.)

Timeline

Start: 2007-09
Primary completion: 2009-01
Completion: 2009-01

Outcome

Met primary endpoint

paper significant efficacy when compared to placebo, as indicated by the primary end point (ACR20 response at week 12) PMID 21952978 ↗

paper primary end point (ACR20 response at week 12), achieved in 39.2% (3 mg; P ≤ 0.05), 59.2% (5 mg; P < 0.0001) PMID 21952978 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adalimumab	Monoclonal antibody	40 mg	Subcutaneous
Subject	Tofacitinib	Small molecule	1 mg	Oral
Subject	Tofacitinib	Small molecule	3 mg	Oral
Subject	Tofacitinib	Small molecule	5 mg	Oral
Subject	Tofacitinib	Small molecule	10 mg	Oral
Subject	Tofacitinib	Small molecule	15 mg	Oral