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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT02758782
• Date of registration: 20/04/2016
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis CONSUL
• Scientific title: 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
• Date of first enrolment: September 2016
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02758782
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Germany

Contacts

• Name: Denis Poddubnyy, Prof. Dr.
• Affiliation: Head of Dpt. for Rheumatology at Charite, Campus Benjamin Franklin

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Biological: Golimumab

Drug: Celecoxib

Primary Outcome(s)

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]

Secondary Outcome(s)

Improvement of disease activity (ASDAS) [Time Frame: 2 years]

Improvement of quality of life measures (ASAS Health Index) [Time Frame: 2 years]

Change of Berlin MRI score (SUBSTUDY) [Time Frame: 2 years]

Improvement of axial mobility (BASMI) [Time Frame: 2 years]

Improvement of function (BASFI) [Time Frame: 2 years]

Adverse events (AE), serious AE and AE of interest until end of study [Time Frame: 2 years]

Change of the enteric microbiome profile at week 108 in comparison to baseline [Time Frame: 2 years]

Improvement of disease activity (BASDAI) [Time Frame: 2 years]

New syndesmophyte formation or progression of existing syndesmophytes [Time Frame: 2 years]

Secondary ID(s)

CONSUL2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors