Pfizer TOFA A3921133-Tofa versus TNFi in Rheumatoid Arthritis
Research type
Research Study
Full title
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF)INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
IRAS ID
148901
Contact name
David Walker
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2013-003177-99
Research summary
The disease under investigation in this trial is Rheumatoid Arthritis. Rheumatoid Arthritis is a chronic and debilitating autoimmune disease characterized by inflammation and destruction of the joints, substantial disability, and a significant impact on health status and quality of life; this results in a substantial economic burden to patients and society.
Tofacitinib is a targeted therapy for patients with Rheumatoid Arthritis. In previous trials, it has been shown to be effective in patients with active Rheumatoid Arthritis.
This study is an event driven study, where sufficient events must be observed to gather data to further evaluate the safety of the marketed drug, Tofacitinib, at two different dose levels, compared to the use of a tumor necrosis factor
inhibitor.Approximately 4000 patients will be involved globally and the trial will take place in a number of UK hospitals.
The expected duration of the study is approximately 5 years following randomization of the first subject. The study will end once the required number of events have been observed. In the first 6 months, patients will need to visit the research site 5 times. After this point, patients need to visit the research site about every 3 months.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0352
Date of REC Opinion
17 Jul 2014
REC opinion
Further Information Favourable Opinion