A3921064 Rheumatoid Arthritis - background methotrexate

• Research type

  Research Study

• Full title

  PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND METHOTREXATE

• IRAS ID

  18591

• Contact name

  Robert J Moots

• Sponsor organisation

  ICON Clinical Research (UK) Ltd

• Eudract number

  2008-008338-35

• Clinicaltrials.gov Identifier

  NCT00853385

• Research summary

  Study A3921064 is a Phase 3 study comparing CP690, 550, Humira© (adalimumab) and placebo in patients with Rheumatoid Arthritis (RA) who are already receiving background methotrexate. CP-690,550 is an oral medication that specifically targets the immune system. The study is intended to provide evidence of control of RA disease activity with improvement in symptoms, such as swelling and pain, and with improvement in every-day functions and activities. The study will also look at long term (1 year) safety of CP690, 550 given in combination with methotrexate and to confirm the benefits observed in the Phase 2 RA studies. The patients will have had an inadequate response to methotrexate alone. There will be 7 visits to the clinic over a year during this study. During this study, patients will get either CP-690,550 5 mg twice a day, CP-690,550 10 mg twice a day, adalimumab 40mg every other week or placebo. Patients will also be getting placebo injections and/or placebo tablets depending on the group they are assigned to. Two out of 5 patients will get placebo for the first 3 months of the study. At Month 3 patients on placebo and background methotrexate who do not show improvement in their painful and swollen joint counts will be switched to CP-690,550 study medication. At Month 6 all patients who were assigned to placebo will be assigned to CP-690,550 study medication for the remainder of the study. The approved injectable medication for RA, adalimumab, is included for comparison. Patients assigned to adalimumab will remain on this therapy for the entire duration of the study. This study will be conducted at approximately 120 sites in 24 countries throughout the world. Study A3921064 is being sponsored by Pfizer Inc.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  09/H1208/25

• Date of REC Opinion

  11 Jun 2009

• REC opinion

  Further Information Favourable Opinion