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NCT Number: NCT04360785

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

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.

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Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Pellegrin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

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

Primary outcomes

  1. serum concentrations of ADAb anti adalimumab

    Time frame: 6 month

    To assess if 2 subcutaneous injections of methotrexate could prevent anti adalimumab antibodies formation at month 6 in patients with spondyloarthritis

Secondary outcomes

  1. residual serum concentration of adalimumab

    Time frame: At 1, 3, 6 and 12 months

    To compare trough levels of adalimumab at month 1, 3, 6 and 12 in the 2 groups.

  2. serum concentrations of ADAb anti adalimumab

    Time frame: At 1, 3 and 12 months

    To compare the percentage of immunized patients at month 1, 3 and 12 in the 2 groups

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: At 1, 3, 6 and 12 months

    Incidence of Treatment-Emergent Adverse Events as assessed by the number of AE and SAE related to the treatment that occur during the participation of the patient

  4. Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using ASDAS (Ankylosing Spondylitis Disease Activity Score) score.

    Time frame: At 3, 6 and 12 months

    A therapeutic efficacity will be described as a clinical pertinent change of ASDAS : Ankylosing Spondylitis Disease Activity Score (at least 1,1 point) (a higher score means a worse outcome)

  5. Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score.

    Time frame: At 3, 6 and 12 months

    A therapeutic efficacity will be described as a clinical pertinent change of BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (0 to 50 points - a higher score means a worse outcome)

  6. Comparison of Adalimumab Therapeutic efficacity in term of therapeutic maintenance

    Time frame: At 3, 6 and 12 months

    Assess by Number of patient who didn't switch treatment

  7. Comparison of Adalimumab Therapeutic efficacity in term of nonsteroidal anti inflammatory drugs ' reduction

    Time frame: At 3, 6 and 12 months

    Assess by ASAS-NSAIDS score (Assessment of SpondyloArthritis international Society - nonsteroidal antiinflammatory drugs) (minimum 0. a higher score means a worse outcome)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Effect of Two Methotrexate Injections in Sync With the First Adalimumab Injection to Prevent the Immunisation Anti Adalimumab During Treatment of Spondyloarthritis

Acronym: MESYNAD

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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