Pfizer A3921092 - Phase 3 Tofacitinib (Active PsA) Extension Study
Research type
Research Study
Full title
A LONG TERM, OPEN LABEL EXTENSION STUDY OF TOFACITINIB (CP 690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
IRAS ID
140698
Contact name
Karen Douglas
Contact email
Sponsor organisation
Pfizer Inc, 235 East 42nd Street, New York, NY10017-5755
Eudract number
2011-002169-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 7 months, 7 days
Research summary
Psoriatic arthritis (PsA) is a chronic inflammatory autoimmune disease characterised by joint inflammation and destruction, psoriatic skin lesions, enthesitis (inflammation of sites where tendons or ligaments insert into bone), dactylitis (inflammation of the fingers or toes), spondylitis (inflammation of the spine), progressive disability and adverse effects on quality of life. There is currently no cure for PsA. The purpose of treatment is to control disease activity, alleviate signs and symptoms, maintain physical function, optimise quality of life, and, if possible, induce complete remission.
Tofacitinib is being developed as a treatment for adult subjects with active PsA. A3921092 is a phase 3, long-term, open-label extension study designed to evaluate the safety, tolerability and efficacy of tofacitinib for treatment of PsA.
All eligible subjects from qualifying tofacitinib studies will receive tofacitinib 5 mg BID (twice daily) by mouth. Tofacitinib dose may be increased to 10 mg BID at study visits if, based upon investigator’s discretion, participants receiving tofacitinib 5 mg BID would benefit from a higher dose and are not experiencing any tofacitinib related adverse events.
This study involves a separate or combined screening and baseline visit (dependent upon entry after the last study visit in the qualifying study), after which participants will return for visits at months 1, 3, 6, 9, and 12 and thereafter every 3 months until month 36 (3 years). Approximately 700 subjects will be enrolled globally at approximately 144 research sites in 17 countries.
Throughout the study subjects will undergo, safety measurements, including physical examination, clinical lab tests, adverse event monitoring, ECGs and vital signs. All participants will be monitored for clinical evidence of response to PsA to treatment. Questionnaires related to psoriasis and quality of life will be completed. Participants will be monitored for serious infections, lymphadenopathy and lymphoproliferative disorder.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1040
Date of REC Opinion
11 Aug 2014
REC opinion
Further Information Favourable Opinion