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

Completed

• Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

• Registration Number: NCT05927064
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

The main objective is to assess the persistence rate of methotrexate treatment in patients followed for chronic inflammatory bowel disease (IBD).

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.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Study Start: 2023-07-21
• Primary Completion: 2024-01-12
• Study Completion: 2024-01-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1282

Inclusion Criteria

1. Person who has received full information on the organization of the research and has not objected to the use of this data
2. Age ≥18 years
3. Certain diagnosis of IBD (European Crohn's Colitis Organization criteria)
4. Introduction of methotrexate mono- or combination therapy between January 1, 2015 and December 31, 2022
5. Minimum 6-month follow-up after initiation of methotrexate therapy
6. Person affiliated with a social security plan or beneficiary of such a plan

Exclusion Criteria

1. Age <18 years

2. Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code

   • Pregnant woman, parturient or nursing mother
   • Minor (not emancipated)
   • Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
   • A person of full age who is unable to give consent

3. Persons deprived of liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistence rate of methotrexate treatment in chronic inflammatory bowel disease patients	minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022	Persistence is measured as the time between starting treatment and stopping the drug or switching to another drug.

Secondary Outcome Measures

Name	Time	Method
Assess the effectiveness of induction therapy with methotrexate for Ulcerative colitis patient	minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022	Clinical response defined as a decrease of at least 3 points in the partial Mayo score for Ulcerative colitis (UC) assessed at 6 months of methotrexate therapy; Mayo score composed by 4 items: stool frequency; rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity.; Mayo score: Score \<2 : no activity Score between 3 and 5: mild activity Score between 6 and 10 :moderate activity Score \>11 : severe activity
Assess the effectiveness of induction therapy with methotrexate for Crohn's patient	minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022	Clinical response defined as a decrease of at least 3 points in the Harvey-Bradshaw Index (HBI) for CD assessed at 6 months of methotrexate therapy.; The Harvey-Bradshaw Index consists of a few questions (n=5) to quickly categorize the severity of Crohn's disease and detect remission.; Harvey-Bradshaw Index Score: Remission: \<5 Mild Disease: 5 to 7 Moderate Disease: 8 to 16 Severe Disease: \>16
Describe the reasons for discontinuation of methotrexate therapy	minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022	Reasons for discontinuing methotrexate: inefficiency and intolerance
Assess the safety of methotrexate therapy	minimum follow-up of 6 months post-induction of treatment and maximum on the date of cessation of treatment or date of last news 12/31/2022	Adverse reactions associated with methotrexate treatment: hematological, hepatic, pulmonary, renal toxicity, allergic reaction, abdominal pain, nausea, vomiting.

Trial Locations

Locations (1)

CHRU of Nancy; 🇫🇷 Vandoeuvre Les Nancy, Grand Est, France