Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis
MESYNAD
Effect of Two Methotrexate Injections in Sync With the First Adalimumab Injection to Prevent the Immunisation Anti Adalimumab During Treatment of Spondyloarthritis
1 other identifier
interventional
124
1 country
17
Brief Summary
Preliminary report have demonstrated that methotrexate induces an anti bio-medicament tolerization whan administrated just before the first administration of the bio-medicament. Once this tolerization is obtained it seems useless to continue the methotrexate because this treatment has no efficacity in cases of spondyloarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
November 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2023
CompletedOctober 4, 2023
April 1, 2023
1.8 years
March 2, 2020
October 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum concentrations of ADAb anti adalimumab
To assess if 2 subcutaneous injections of methotrexate could prevent anti adalimumab antibodies formation at month 6 in patients with spondyloarthritis
6 month
Secondary Outcomes (7)
residual serum concentration of adalimumab
At 1, 3, 6 and 12 months
serum concentrations of ADAb anti adalimumab
At 1, 3 and 12 months
Incidence of Treatment-Emergent Adverse Events
At 1, 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using ASDAS (Ankylosing Spondylitis Disease Activity Score) score.
At 3, 6 and 12 months
Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score.
At 3, 6 and 12 months
- +2 more secondary outcomes
Study Arms (2)
Methotrexate + Adalimumab
EXPERIMENTALExperimental group : patients will receive 2 subcutaneous injections of methotrexate in addition of the usual adalimumab
Adalimumab
NO INTERVENTIONReference group : patient will receive adalimumab as usual to treat spondyloarthritis
Interventions
Patients randomized in this arm will have one subcutaneous injection of methotrexate 15min before and one 24h after their first injection of adalimumab prescribed as usual
Eligibility Criteria
You may qualify if:
- Patients aged from 18 to 90
- Patients suffering from axial SpA, radiographic or non-radiographic according to ASAS criteria (peripheral involvement and/or Inflammatory bowel diseases could be present).
- Indication for anti TNF treatment: resistance to at least 2 NSAIDs and no contraindication to adalimumab
- No previous treatment with methotrexate in the last 3 months
- Stable dosage of steroids (less than 10mg/day of prednisone equivalent) and/or of NSAIDs for at least 10 days
- Contraception feminine or masculine
- Informed and written consent
- Social insurance
You may not qualify if:
- Contraindication to methotrexate
- Previous treatment with adalimumab
- Steroids more than 10mg/day of prednisone equivalent
- Previous treatment with:
- Etanercept in the last month
- Infliximab, golimumab, certolizumab in the last 2 months (Previous treatment hereafter these dates with anti-TNF except adalimumab or secukinumab are not a counterindication)
- Current immunosuppressive drugs except methotrexate
- Current and proven pregnancy
- Legal safeguards
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Hopital Pellegrin
Bordeaux, France
Hopital Ambroise Paré
Boulogne-Billancourt, France
Hopital La Cavale Blanche
Brest, France
CHU Trousseau
Chambray-lès-Tours, France
CH Sud Francilien
Corbeil-Essonnes, France
Hopital Mondor
Créteil, France
Kremlin Bicetre hospital
Le Kremlin-Bicêtre, France
CH Le Mans
Le Mans, France
Hopital Saint Philibert
Lille, France
CHU Nantes
Nantes, France
CHR Orléans
Orléans, France
Hopital Bichat
Paris, France
Hopital Cochin
Paris, France
Hopital la Pitié Salpétrière
Paris, France
Hopital Saint Antoine
Paris, France
CH Pontoise
Pontoise, France
CHU Rouen
Rouen, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
gaetane Nocturne
APHP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
April 24, 2020
Study Start
November 11, 2020
Primary Completion
September 13, 2022
Study Completion
February 27, 2023
Last Updated
October 4, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share