M13-375, Adalimumab, non-radiographic axial Spondyloarthritis study
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis
IRAS ID
131163
Contact name
Helena Marzo-Ortega
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2012-000646-35
Clinicaltrials.gov Identifier
Research summary
This is a study of a drug called Adalimumab, intended for patients suffering with axial spondyloarthritis (AS) without x-ray changes present (non-radiographic axial Spondyloartiritis; nr-axSpA). AS refers to an inflammatory disease (where the body’s defence/ immune system inappropriately triggers an inflammatory response) which can be a debilitating condition that presents with prolonged back pain, stiffness and swollen/tender joints. Adalimumab is a human protein, and works by blocking the tumour necrosis factor alpha (TNF alpha; α-TNF) that the body’s immune system makes.
There is an unmet medical need for treatment in nr-axSpA patients who fail the first line therapy known as non-steroidal anti-inflammatory drug (NSAIDs). This research is to assess effectiveness and safety of continuing versus withdrawing adalimumab therapy. This study is being conducted on European Medicines Agency recommendation to further investigate the withdrawal effect of adalimumab for patients in remission with nr-axSpA.
This study will recruit adult subjects with nr-axSpA who have evidence of active inflammation in the sacroiliac joints (sacrum is located at the base of the spine; iliac bones are the two large bones that make up the pelvis. The sacroiliac joint is where the sacrum and iliac bones join) or spine on Magnetic Resonance Imaging (medical imaging technique; MRI), or elevated high sensitivity C-reactive protein (protein made by the liver when inflammation is present).
Approximately 740 subjects will be recruited from 150 hospitals worldwide. Sites will be rheumatology departments, specifically National Health Service (NHS) sites in the UK.
Participation will last approximately 68 weeks, but it could be as little as 20 weeks (if subjects do not meet remission criteria) or as long as 80 weeks (if subjects experience disease flare). At the scheduled visits, subjects will need to visit the site where several assessments will take place (physical examination, blood tests, Electrocardiogram, X-rays, MRI, completing questionnaires).
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0174
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion