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

• Status: Completed
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Antibodies, Monoclonal; Celecoxib; Golimumab

Criteria

Major Inclusion Criteria:

• Definite diagnosis of AS according to the "modified New York criteria".

• History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each.

• Active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) value of ≥4 at screening.

• Presence of at least one of the following risk factors for radiographic spinal progression:

1. Elevated C reactive protein (CRP; >5mg/l) at screening at the absence of reasons for elevated CRP other than AS;

2. Presence of ≥ 1 syndesmophyte on prior X-rays of the spine.

• Subject is a candidate for anti-TNF therapy based on the Investigator's opinion.

• Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.

• If female: either unable to bear children (postmenopausal for at least 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study and 6 months after

Inclusion Criterion for Phase II (randomized part of the study):

• adequate response to Golimumab during Phase I (referred to as decline in BASDAI)

Major Exclusion Criteria:

• For female subjects: pregnancy or lactating

• subjects with chronic inflammatory articular disease other than spondyloarthritis / AS or systemic autoimmune disease, e.g. systemic lupus erythematosus, Sjögren´s syndrome, rheumatoid arthritis.

• history of inadequate response to anti-TNF-therapy

• intolerability/hypersensitivity to one of the drugs or other components of the study medication

• presence ot total spinal ankylosis

• contraindications to anti-TNF-therapy (current or remitting clinical significant infections, tuberculosis, viral hepatitis, HIV; malignancies; demyelinating disease; vaccination with live vaccine within 3 months before, during and until 6 months after study)

• (relative) contraindications to Celecoxib therapy (uncontrolled arterial hypertension, high cardiovascular risk / history of cardiovascular events; history of gastrointestinal ulcers or relevant bleeding; known M. Crohn or ulcerative colitis)

• diagnosis of fibromyalgia

• significant lab abnormalities