NCT05927064Completed
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
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1282 (actual)
- First submitted
- 7 Jun 2023
- Start date
- 21 Jul 2023
- Primary completion date
- 12 Jan 2024
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05927064
What you commit to
- Study type: Observational
- Participants enrolled: 1282
- From 21 Jul 2023 to the primary completion date, 12 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Age \<18 years
- 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
Who the study is looking for
- Person who has received full information on the organization of the research and has not objected to the use of this data
- Age ≥18 years
- Certain diagnosis of IBD (European Crohn's Colitis Organization criteria)
- Introduction of methotrexate mono- or combination therapy between January 1, 2015 and December 31, 2022
- Minimum 6-month follow-up after initiation of methotrexate therapy
- Person affiliated with a social security plan or beneficiary of such a plan
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU of NANCY Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.