Inflammatory Bowel DiseasesMICI-METHONCT05927064
Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 1,282 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2023to 12 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients followed for IBD treated with methotrexate between 01/01/2015 and 12/31/2022.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients
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).
Read the 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.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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
Measured: 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
Adverse reactions associated with methotrexate treatment: hematological, hepatic, pulmonary, renal toxicity, allergic reaction, abdominal pain, nausea, vomiting.
Measured: 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
Reasons for discontinuing methotrexate: inefficiency and intolerance
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start21 Jul 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARON Bénédicte, Central Hospital, Nancy, France
- Investigators
- Bénédicte CARON, MD, Principal investigator, CHRU of Nancy, Hepatogastroenterology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927064
- Sponsor's protocol ID
- 2023PI032
- Acronym
- MICI-METHO
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 7816064Mate-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.
PubMed 11111780Nielsen 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.
PubMed 30895827Ardizzone 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.
PubMed 14563183
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Evaluating the Persistence, Efficacy and Tolerability of Methotrexate in Inflammatory Bowel Disease Patients
- ClinicalTrials.gov ID
- NCT05927064
- Acronym / sponsor ID
- MICI-METHO / 2023PI032
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,282 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients followed for IBD treated with methotrexate between 01/01/2015 and 12/31/2022.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Age <18 years
- Person referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Persistence rate of methotrexate treatment in chronic inflammatory bowel disease patients
Time frame: 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.
4 secondary outcomes
Assess the effectiveness of induction therapy with methotrexate for Crohn's patient
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Results publication: PubMed 7816064Feagan 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.
- Results publication: PubMed 11111780Mate-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.
- Results publication: PubMed 30895827Nielsen 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.
- Results publication: PubMed 14563183Ardizzone 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bénédicte CARON, MD principal investigator
CHRU of Nancy, Hepatogastroenterology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence rate of methotrexate treatment in chronic inflammatory bowel disease patients (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927064, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.