Trials / Completed

CompletedNCT05927064

Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients

Multicenter Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,282 (actual)

Sponsor: Central Hospital, Nancy, France · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: —

Summary

Detailed description

Methotrexate is one of the immunosuppressants used in chronic inflammatory bowel disease (IBD). It is indicated as monotherapy for induction and maintenance treatment of Crohn's disease (CD), or in combination with anti-tumor necrosis factor (TNF) agents for prevention of immunization Thiopurines are the most commonly used immunosuppressants in IBD, which contrasts with rheumatology data where methotrexate is the first-line immunosuppressant. Thiopurines and methotrexate have equivalent efficacy in CD 4. Methotrexate is available in injectable (intramuscular (IM) or subcutaneous (SC)) or tablet form. In IBD, only parenteral administration has been shown to be effective. There is no consensus on the optimal maintenance dosage. Tolerance problems remain an obstacle to its use, even if the side effects are not severe. In this context, the objectives of this study are to describe the use of methotrexate in current practice in patients followed for IBD, its persistence, compliance, tolerance, as well as the factors associated with the persistence of treatment.

Conditions

Timeline

Start date: 2023-07-21
Primary completion: 2024-01-12
Completion: 2024-01-12
First posted: 2023-07-03
Last updated: 2024-03-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05927064. Inclusion in this directory is not an endorsement.