A3921024 RA long term follow up of CP-690,550
Research type
Research Study
Full title
A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF CP-690,550, A MODERATELY SELECTIVE JANUS-KINASE-3 INHIBITOR, FOR TREATMENT OF RHEUMATOID ARTHRITIS
IRAS ID
19631
Sponsor organisation
ICON Clinical Research (UK) Ltd
Eudract number
2006-005035019
Clinicaltrials.gov Identifier
Research summary
This is a long term, open label, follow up study which enables adult patients with moderate to severe rheumatoid arthritis who have successfully completed a phase 2 or 3 clinical study to continue therapy for an extended period. The sponsor Pfizer is funding the study and will make CP690, 550 available to participants for at least two years after first global marketing approval. In the UK, individual patient participation is currently limited to 3 years.Participants who are enrolled in randomized studies of CP690, 550 and have derived benefit will be offered extended therapy. Subject to additional consent and meeting eligibility criteria the final visit of the randomized study will be combined with the screening and baseline visit for this study. The study is primarily to evaluate the persistence of efficacy of CP690, 550 when dosed at 5mg BID and 10mg BID and confirm the long-term durability of benefits of CP690, 550 in improving signs and symptoms and physical function that were observed in the initial study. Depending on the design of the initial study patients will continue on stable background therapy, which can include NSAIDS, COX2 inhibitors, and opioids plus certain allowed DMARDS (methotrexate, fluomide, sulfasalazine, anti malarials, auranofin and injectable gold preparations at approved doses). Study visits will occur at 1, 2, 3 months after baseline, then every 3 months as long as the patient remains in the study. At the various time points safety measurements including physical examinations, clinical laboratory tests, adverse event monitoring, ECGs and vital signs will be performed. Patient Reported Outcomes analysis measurements (pain, quality of life, physical function, fatigue, work limitations, health care resource utilization and health status assessment questionnaires) will also be performed. Throughout this trial, patients will especially be monitored for clinical evidence of response of RA to treatment and any adverse events.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
09/H1208/33
Date of REC Opinion
3 Sep 2009
REC opinion
Further Information Favourable Opinion