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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02758782
Other study ID # CONSUL2016
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2016
Est. completion date January 2021

Study information

Verified date January 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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).


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Study Design


Intervention

Biological:
Golimumab

Drug:
Celecoxib


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Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Proft F, Muche B, Listing J, Rios-Rodriguez V, Sieper J, Poddubnyy D. Study protocol: COmparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a thera — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 2 years
Secondary New syndesmophyte formation or progression of existing syndesmophytes New syndesmophyte formation or progression of existing syndesmophytes 2 years
Secondary Improvement of disease activity (BASDAI) Improvement of disease activity (BASDAI) 2 years
Secondary Improvement of disease activity (ASDAS) Improvement of disease activity (ASDAS) 2 years
Secondary Improvement of function (BASFI) Improvement of function (BASFI) 2 years
Secondary Improvement of axial mobility (BASMI) Improvement of axial mobility (BASMI) 2 years
Secondary Improvement of quality of life measures (ASAS Health Index) Improvement of quality of life measures (ASAS Health Index) 2 years
Secondary 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 2 years
Secondary Change of Berlin MRI score (SUBSTUDY) Change of Berlin MRI score (SUBSTUDY) 2 years
Secondary 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 2 years
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