NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis

Sponsor
Charite University, Berlin, Germany
Study ID
NCT02758782
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Sep 30, 2016
Status verified
Jan 2021
Primary completion
Jan 31, 2021
Completion
Jan 31, 2021

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Golimumab monotherapy
    Treatment with 50 mg Golimumab subcutaneous once monthly
  • Active Comparator: Golimumab combined with Celecoxib
    Treatment with Golimumab 50 mg subcutaneous once monthly in combination with Celecoxib 400 mg orally every day

Primary Outcome Measure

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 ]

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