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CONSUL - COmparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis: a randomized controlled multicentre trial

Clinical trial registration: NCT02758782

The goal of the project is to optimize the treatment of ankylosing spondylitis, as well as to improve the long-term prognosis of the disease. Two treatment strategies, aimed at slowing down progression of structural damage in the spine (new bone formation) are compared in a multicenter study: mono-therapy with TNF-blocker (golimumab) and a combination therapy of golimumab and non-steroidal anti-inflammatory drug (celecoxib).

A total of 170 patients are to be included in the study within 18 months of recruitment period by 21 sites in Germany. Included patients are firstly treated with golimumab for 3 months. Patients showing good treatment responce after 3 months of treatment are to be randomly assigned to one of two study grouls (golimumab monotherapy or golimumab plus celecoxib). The primary outcome measure of the study is radiographic progression in the spine in both treatment groups after 2 years of therapy.

In clinical practice, non-steroidal anti-inflammatory drugs are often cancelled after initiation of treatment with TNF-blockers, so the effects of combination therapy are not well investigated so far. There are data showing that non-steroidal anti-inflammatory drugsmay have not only symptomatic, but disease-modifying effect by inhibiting new bone formation in the spine in patients with ankylosing spondylitis. Previous works have shown that treatment with non-COX-II-selective non-steroidal anti-inflammatory drug itself had no inhibitory effect on radiographic progression in the spine in patients with ankylosing spondylitis. In this study, the effects of a COX-II-selective non-steroidal anti-inflammatory drug now to be examined.

Study protocol v.1.3 - 13.02.2017

BMBF logo - englisch
BMBF logo - englisch

The study drug golimumab was provided by MSD SHARP & DOHME GMBH