Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis

NCT ID: NCT04360785

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2023-02-27

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.

Detailed Description

spondyloarthritis are treated in first intention by NSAIDs but in case of inefficacity biotherapies that inhib the TNF are used. Adalimumab is the most used anti TNF in this indication. Monoclonal antibody uses in therapy is immunogene, and there is a clear link between increase of anti drug antibody and in one hand decrease of drug serum concentration and in an other failure of the therapeutic response. With adalimumab there is an apparition of ADAb in 30%. There are reports suggesting that adding methotrexate to the therapy in a specific timeline allow to prevent the immunization. A previous study shows that association in long terms between methotrexate and adalimumab induce less immunized patients. The investigator's goal is to assess if two methotrexate subcutaneous injections at day 1 and 2 could prevent anti adalimumab antibodies formation.

Conditions

Spondyloarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Methotrexate + Adalimumab

Experimental group : patients will receive 2 subcutaneous injections of methotrexate in addition of the usual adalimumab

Group Type: EXPERIMENTAL

Methotrexate

Intervention Type: DRUG

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

Adalimumab

Reference group : patient will receive adalimumab as usual to treat spondyloarthritis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Methotrexate

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Project of pregnancy in the next 3 months following inclusion
• Legal safeguards
• Inclusion in another interventional research project

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

gaetane Nocturne

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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

Countries

France

Other Identifiers

APHP180571

Identifier Type: -

Identifier Source: org_study_id