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Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes (STOP)

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ClinicalTrials.gov Identifier: NCT02469753
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:

Ankylosing spondylitis (AS) is a frequent chronic inflammatory rheumatic disease that affects the axial skeleton, starting in the sacroiliac joints and spreading to the spine in most patients. Non-steroidal anti-inflammatory drugs (NSAIDs) are the primary treatment for AS. Even if the use of anti-TNF agents has demonstrated good clinical efficacy in controlling inflammation, in contrast to other conditions such as rheumatoid arthritis and psoriatic arthritis, anti-TNF treatment has failed to demonstrate any benefit on the structural progression of AS, some data even suggesting that it may accelerate the formation of syndesmophytes that seems to be an independent process of TNF. Conversely, NSAIDs inhibit ossification phenomena independently of their anti-inflammatory properties, owing to a specific action on bone formation via prostaglandin inhibition.

Several features suggest that a continuous NSAID therapy is needed, in addition to anti-TNF treatment, to prevent syndesmophyte formation in AS patients.


Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: NSAIDs Drug: anti-TNF Phase 3

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Study Type : Interventional
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Continuous Non-Steroidal Anti-Inflammatory Drug Treatment in Ankylosing Spondylitis Patients Treated by Anti-TNF Therapy in the Prevention of Radiographic Outcomes
Actual Study Start Date : October 23, 2015
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients treated with anti-TNF and continuous daily NSAIDs Drug: NSAIDs
continuous daily

Drug: anti-TNF
Active Comparator: Patients treated with anti-TNF and NSAIDs on demand Drug: NSAIDs
on demand

Drug: anti-TNF



Primary Outcome Measures :
  1. Proportion of patients who show a significant radiographic progression between the two randomised groups of patients [ Time Frame: 24 month after the begin of the treatment ]

Secondary Outcome Measures :
  1. Radiologic evolution between-group comparison [ Time Frame: At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment) ]

    This measure is a composite with :

    • MRI
    • Clinical evolution of patients
    • Quantitative analysis of mSASSS score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged over 18 years old
  • Patients who fulfil 1984 modified New York criteria for ankylosing spondylitis:
  • SA patients with indications for anti-TNF treatment initiation according to the French society of Rheumatology guidelines.
  • Being affiliated to a health insurance system
  • Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)

Exclusion Criteria:

  • Patients who present another chronic systemic inflammatory disorder, different from ankylosing spondylitis.
  • Patients who present contraindications to treatment with NSAIDs.
  • Patient with daily corticosteroid treatment at a dosage ≥ 10 mg/day
  • Pregnant or breastfeeding women
  • Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing to undergo MRI
  • Women that refuse to an effective contraception method for all the study duration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469753


Contacts
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Contact: Thierry SCHAEVERBEKE, Prof (0)556795556 ext +33 thierry.schaeverbeke@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD (0)557820493 ext +33 thomas.barnetche@chu-bordeaux.fr

Locations
Show Show 22 study locations
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Rodolphe THIEBAUT, Prof University Hospital Bordeaux, France
Principal Investigator: Thierry SCHAEVERBEKE, Prof University Hospital Bordeaux, France
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02469753    
Other Study ID Numbers: CHUBX2014/36
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Keywords provided by University Hospital, Bordeaux:
NSAIDs
Anti-TNF
syndesmophytes
mSASSS
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents