The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or placebo.
A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
Royal United Hospitals Bath
Bath, United Kingdom
University Hospital Birmingham
Birmingham, United Kingdom
University Hospital Coventry and Warwickshire
Coventry, United Kingdom
Northwick Park Hospital
London, United Kingdom
The Proportion of Subjects Who Achieved ASAS20 Clinical Response
The primary endpoint was the proportion of subjects who achieved an Assessment in Ankylosing Spondylitis with 20% improvement (ASAS20) clinical response at Week 12. An ASAS20 clinical response was defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0 to 100 scale in at least three of the following four domains collected in the electronic case report form (eCRF) and no worsening in the fourth domain: Subject's Global Assessment of Disease Status, Subject's Assessment of Spinal Pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]) and inflammation (last two questions of the BASDAI). Lower values within the individual domains represent less severe symptoms.
Time frame: Weeks 12
Proportion of Subjects Who Achieved ASAS40 Clinical Response at Week 12
Proportion of subjects who achieved Assessment in Ankylosing Spondylitis with 40% improvement (ASAS40) response at Week 12
Time frame: Week 12
Proportion of Subjects Who Achieved an ASAS20 Clinical Response at Week 6
Proportion of subjects who achieved an ASAS20 clinical response at Week 6
Time frame: Week 6
Proportion of Subjects Who Achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) Response at Weeks 6
Proportion (percentage) of subjects who achieved Ankylosing Spondylitis Disease Activity Score C-reactive Protein (ASDAS-CRP) response at Week 6, Clinically Important Improvement
Time frame: Week 6
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12
Proportion of Subjects Who Achieved Clinically Important ASDAS-CRP Score at Week 12, Clinically Important Improvement
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Whipps Cross Hospital
London, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Oxford University Hospital
Oxford, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Haywood Hospital
Stoke-on-Trent, United Kingdom
Time frame: Week 12