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

NCT05927064 | Completed

• 1 other identifier: 2023PI032
• Study Type: observational
• Target: 1,282
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Persistence rate of methotrexate treatment in chronic inflammatory bowel disease patients

  Persistence is measured as the time between starting treatment and stopping the drug or switching to another drug.

  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

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients followed for IBD treated with methotrexate between 01/01/2015 and 12/31/2022.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU of Nancy

Vandœuvre-lès-Nancy, Grand Est, 54511, France

Location

Related Publications (4)

• Feagan BG, Rochon J, Fedorak RN, Irvine EJ, Wild G, Sutherland L, Steinhart AH, Greenberg GR, Gillies R, Hopkins M, et al. Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators. N Engl J Med. 1995 Feb 2;332(5):292-7. doi: 10.1056/NEJM199502023320503.

  PMID: 7816064 RESULT

• Mate-Jimenez J, Hermida C, Cantero-Perona J, Moreno-Otero R. 6-mercaptopurine or methotrexate added to prednisone induces and maintains remission in steroid-dependent inflammatory bowel disease. Eur J Gastroenterol Hepatol. 2000 Nov;12(11):1227-33. doi: 10.1097/00042737-200012110-00010.

  PMID: 11111780 RESULT

• Nielsen OH, Ainsworth MA, Steenholdt C. Methotrexate for inflammatory bowel disease: time for reconsideration. Expert Rev Gastroenterol Hepatol. 2019 May;13(5):407-409. doi: 10.1080/17474124.2019.1596797. Epub 2019 Mar 21. No abstract available.

  PMID: 30895827 RESULT

• Ardizzone S, Bollani S, Manzionna G, Imbesi V, Colombo E, Bianchi Porro G. Comparison between methotrexate and azathioprine in the treatment of chronic active Crohn's disease: a randomised, investigator-blind study. Dig Liver Dis. 2003 Sep;35(9):619-27. doi: 10.1016/s1590-8658(03)00372-4.

  PMID: 14563183 RESULT

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Bénédicte CARON, MD

  CHRU of Nancy, Hepatogastroenterology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 3, 2023
• Study Start: July 21, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

FR (1)