To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) - Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS).
The aim of the proposed trial is to evaluate the efficacy of combined treatment with a non-steroidal anti-inflammatory drug (NSAID) added to anti-tumour necrosis factor (TNF) therapy as compared to anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS). The trial consists of two phases. In the phase I (run-in phase), patients with active AS despite treatment with NSAIDs and elevated C-reactive protein will be included and treated with a TNF blocker (golimumab). Patients with good clinical response to golimumab at week 12 will be eligible for the phase II (core phase) of the study and will be randomized 1:1 to 1) golimumab + celecoxib (experimental intervention) for 2 years (weeks 12-108) or 2) golimumab alone (control intervention) also for 2 years. The primary outcome parameter will be the absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) - currently a standard of structural spinal damage progression evaluation in AS - over two years of therapy (weeks 12-108).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
156
Rheumapraxis Kupka
Altenburg, Germany
Rheumapraxis Bayreuth Dr. Ochs
Bayreuth, Germany
Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial
Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial
Time frame: 2 years
New syndesmophyte formation or progression of existing syndesmophytes
New syndesmophyte formation or progression of existing syndesmophytes
Time frame: 2 years
Improvement of disease activity (BASDAI)
Improvement of disease activity (BASDAI)
Time frame: 2 years
Improvement of disease activity (ASDAS)
Improvement of disease activity (ASDAS)
Time frame: 2 years
Improvement of function (BASFI)
Improvement of function (BASFI)
Time frame: 2 years
Improvement of axial mobility (BASMI)
Improvement of axial mobility (BASMI)
Time frame: 2 years
Improvement of quality of life measures (ASAS Health Index)
Improvement of quality of life measures (ASAS Health Index)
Time frame: 2 years
Change of the enteric microbiome profile at week 108 in comparison to baseline
Change of the enteric microbiome profile at week 108 in comparison to baseline
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Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte
Berlin, Germany
Rheumatologische Schwerpunktpraxis
Berlin, Germany
Rheumatologische Praxis Dr. Karberg/Brandt
Berlin, Germany
Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Benjamin Franklin
Berlin, Germany
MVZ Drs. Mielke
Berlin, Germany
Rheumapraxis Dr. Zinke
Berlin, Germany
Schlossparkklinik, Dpt. of Rheumatologie
Berlin, Germany
Rheumatologische Schwerpunktpraxis an den Kreiskliniken
Burghausen, Germany
...and 9 more locations
Time frame: 2 years
Change of Berlin MRI score (SUBSTUDY)
Change of Berlin MRI score (SUBSTUDY)
Time frame: 2 years
Adverse events (AE), serious AE and AE of interest until end of study
Adverse events (AE), serious AE and AE of interest until end of study
Time frame: 2 years