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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)

Primary Purpose

Ankylosing Spondylitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NSAIDs
NSAIDs
anti-TNF
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring NSAIDs, Anti-TNF, syndesmophytes, mSASSS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de rhumatologie - CHU d'Amiens
  • Service de rhumatologie - CHU de Besançon
  • Service de Rhumatologie - CHU de Bordeaux
  • service de rhumatologie - AP-HP - Hôpital Ambroise Paré
  • Service de rhumatologie - CHU de Brest
  • service de rhumatologie - CH de Cahors
  • service de rhumatologie - CH Le Mans
  • service de rhumatologie - CHU de Limoges
  • service de rhumatologie - CHU de Montpellier
  • service de rhumatologie - CHU de Nancy
  • Service de rhumatologie - CHU de Nice
  • service de rhumatologie - CHR d'Orléans
  • service de rhumatologie - AP-HP - Hôpital Henri Mondor
  • Service de rhumatologie - AP-HP - Hôpital Lariboisière
  • service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
  • service de rhumatologuie - CH de Pau
  • service de rhumatologie - CHU de Rouen
  • service de rhumatologie - CHU de Saint-Etienne
  • service de rhumatologie - CHU de Strasbourg
  • service de rhumatologie - CHU de Toulouse
  • Service de rhumatologie - CHU de Tours
  • service de Rhumatologie - CH Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients treated with anti-TNF and continuous daily NSAIDs

Patients treated with anti-TNF and NSAIDs on demand

Arm Description

Outcomes

Primary Outcome Measures

Proportion of patients who show a significant radiographic progression between the two randomised groups of patients

Secondary Outcome Measures

Radiologic evolution between-group comparison
This measure is a composite with : MRI Clinical evolution of patients Quantitative analysis of mSASSS score

Full Information

First Posted
June 9, 2015
Last Updated
March 14, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02469753
Brief 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
Acronym
STOP
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2015 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
NSAIDs, Anti-TNF, syndesmophytes, mSASSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with anti-TNF and continuous daily NSAIDs
Arm Type
Experimental
Arm Title
Patients treated with anti-TNF and NSAIDs on demand
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
NSAIDs
Intervention Description
continuous daily
Intervention Type
Drug
Intervention Name(s)
NSAIDs
Intervention Description
on demand
Intervention Type
Drug
Intervention Name(s)
anti-TNF
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Radiologic evolution between-group comparison
Description
This measure is a composite with : MRI Clinical evolution of patients Quantitative analysis of mSASSS score
Time Frame
At the inclusion (Day 0) and 24 month after after the inclusion (Day 0)(begin of the treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolphe THIEBAUT, Prof
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thierry SCHAEVERBEKE, Prof
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de rhumatologie - CHU d'Amiens
City
Amiens
Country
France
Facility Name
Service de rhumatologie - CHU de Besançon
City
Besancon
Country
France
Facility Name
Service de Rhumatologie - CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
service de rhumatologie - AP-HP - Hôpital Ambroise Paré
City
Boulogne-billancourt
Country
France
Facility Name
Service de rhumatologie - CHU de Brest
City
Brest
Country
France
Facility Name
service de rhumatologie - CH de Cahors
City
Cahors
Country
France
Facility Name
service de rhumatologie - CH Le Mans
City
Le Mans
Country
France
Facility Name
service de rhumatologie - CHU de Limoges
City
Limoges
Country
France
Facility Name
service de rhumatologie - CHU de Montpellier
City
Montpellier
Country
France
Facility Name
service de rhumatologie - CHU de Nancy
City
Nancy
Country
France
Facility Name
Service de rhumatologie - CHU de Nice
City
Nice
Country
France
Facility Name
service de rhumatologie - CHR d'Orléans
City
Orleans
Country
France
Facility Name
service de rhumatologie - AP-HP - Hôpital Henri Mondor
City
Paris
Country
France
Facility Name
Service de rhumatologie - AP-HP - Hôpital Lariboisière
City
Paris
Country
France
Facility Name
service de rhumatologie - AP-HP- Hôpital La Pitié Salpétrière
City
Paris
Country
France
Facility Name
service de rhumatologuie - CH de Pau
City
PAU
Country
France
Facility Name
service de rhumatologie - CHU de Rouen
City
Rouen
Country
France
Facility Name
service de rhumatologie - CHU de Saint-Etienne
City
Saint-etienne
Country
France
Facility Name
service de rhumatologie - CHU de Strasbourg
City
Strasbourg
Country
France
Facility Name
service de rhumatologie - CHU de Toulouse
City
Toulouse
Country
France
Facility Name
Service de rhumatologie - CHU de Tours
City
Tours
Country
France
Facility Name
service de Rhumatologie - CH Princesse Grace
City
Monaco
Country
Monaco

12. IPD Sharing Statement

Learn more about this trial

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

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