A3921120 Phase 3 Active Ankylosing Spondylitis (AS) Tofacitinib
Research type
Research Study
Full title
A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (AS)
IRAS ID
245668
Contact name
Hasan Tahir
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2018-000226-58
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Ankylosing Sponsylitis (AS) is a disease in which chronic inflammation causes the bone to erode mainly in the spine and sacroiliac joints (joints between the hip and the spine) and this inflammation is believed to cause new bone to form on the outer edge of the spine. The new bone formation causes the spine to become rigid and may lead to a fusion of the spine over time.
Tofacitinib is a drug that affects the immune system. In AS, the patient's immune system can act abnormally and cause inflammation in their joints. Tofacitinib may dampen the effects of the immune cells that cause the inflammation to the joints. Tofacitinib is being developed as a disease-modifying drug for the treatment of AS. The purpose of this type of treatment is to improve spine and joint symptoms.
A previous phase 2 study, A3921119, was conducted in AS patients with an inadequate response to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This study, A3921120, is a phase 3 study designed to evaluate the efficacy and safety of Tofacitinib in patient with active AS.
Eligible patients will be assigned by chance to receive either Tofacitinib 5mg BID (twice daily) or placebo for 16 weeks. For the remaining 32 weeks, patients will be given Tofacitinib 5mg BID (twice daily).
The duration of participation will be approximately 56 weeks. This includes a screening period of approximately 30 days, a 16-week double-blind treatment period, a 32-week open-label treatment period and a 28-day follow-up period.
Approximately 240 patients will be enrolled globally at approximately 100 research sites in 23 countries.
Throughout the study, participants will undergo physical examination, vital signs and Electrocardiogram (ECG) or heart assessment, adverse event monitoring, blood tests, and will be monitored for clinical evidence of response to AS treatment. Questionnaires related to AS and quality of life will be completed.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
18/WM/0194
Date of REC Opinion
13 Aug 2018
REC opinion
Further Information Favourable Opinion