Chronic Inflammatory Bowel DiseaseMTXNCT04196920
Methotrexate-associated Anti-TNF Combination Therapy, the Neglected One !
An observational study of Chronic Inflammatory Bowel Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Bowel Disease
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2019to 30 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha (infliximab, adalimumab) from January 2013 to November 2019
Who may be able to join
- Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha
Who cannot join
- Subject unable to read
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Methotrexate-associated Anti-TNF Alpha (Infliximab/Adalimumab) Combination Therapy: Evaluation of Efficacy and Safety Compared to Traditional Azathioprine-associated Combination Therapy in Patients With Chronic Inflammatory Bowel Disease.
The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). The benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy).
Data on the use of immunosuppressive methotrexate treatment are divergent. Indeed, a previous randomized trial suggested that the combination of anti-TNF alpha including infliximab and methotrexate was no more effective than anti-TNF alpha monotherapy in patients with Crohn's disease. However, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time.
Read more
In practice, more and more practitioners are prescribing this combination (antiTNF and MTX) in IBD patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint.
The interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.
Read the detailed description
Data will be extracted from medical records (age, gender, smoking status, date of diagnosis of chronic inflammatory disease, date of first prescription of antiTNF alpha either infliximab or adalimumab, date of start and end of immunosuppressive azathioprine/6MP and/or metrotrexate, mode of administration of per os or SC/IV treatment, efficacy based on validated clinical scores HBI-PDAI-Mayo, tolerance). A collection will be made on the University Hospital from a computer workstation. An analysis will then be carried out to write the publication secondarily. The data retention period will be one year from November 2019 to November 2020 depending on the duration of this thesis work, which is estimated at one year.
Expected results and prospects : " Methotrexate-associated antiTNF alpha combination therapy is as effective and safe as traditional azathioprine combination therapy in patients with IBD. The positive results may in practice lead to changes in our practices and give first priority to this combination therapy with methotrexate. "
- Conditions
- Chronic Inflammatory Bowel Disease
- Keywords
- Crohn's disease, ulcerated ulcerative colitis
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort with TNF combination therapy | Cohort with TNF combination therapy (infiximab/adalimumab) with azathiorpine | |
| Cohort with anti-TNF combination therapy | Cohort with anti-TNF combination therapy (infiximab/adalimumab) with methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of anti-TNF alpha and methotrexate combination therapy
Evaluation of the efficacy of anti-TNF alpha and methotrexate combination therapy compared to conventional azathioprine combination therapy. Efficacy is defined according to response and remission without corticosteroids based on clinical scores, biological markers, endoscopic criteria and immunization rates.
Measured: through study completion, an average of 7 years
Secondary outcomes (1)
Tolerance assessment of anti-TNF alpha and methotrexate combination therapy
Tolerance assessment of anti-TNF alpha and methotrexate combination therapy compared to conventional azathioprine combination therapy. Number of stops for treatment intolerance, minor adverse events, severe adverse events, infection rate, cancer risk
Measured: 6 months, one year, two years, and date on the latest news
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start20 Dec 2019
- Primary completion1 May 2020
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Najima BOUTA, Resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196920
- Sponsor's protocol ID
- RECHMPL19_0580
- Acronym
- MTX
- Status last verified
- Jun 2020
- First submitted
- 4 Dec 2019
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate-associated Anti-TNF Alpha (Infliximab/Adalimumab) Combination Therapy: Evaluation of Efficacy and Safety Compared to Traditional Azathioprine-associated Combination Therapy in Patients With Chronic Inflammatory Bowel Disease.
- ClinicalTrials.gov ID
- NCT04196920
- Acronym / sponsor ID
- MTX / RECHMPL19_0580
- Conditions
- Chronic Inflammatory Bowel Disease
- Keywords
- Crohn's disease, ulcerated ulcerative colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Rennes University Hospital
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 12 Dec 2019 (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.
The results of the SONIC trial represented a significant advance in the management of patients with chronic inflammatory bowel disease by demonstrating the superiority of the combination of an alpha TNF anti-TNF with immunosuppressive therapy in naive patients (infliximab and azathioprine) compared to monotherapy in terms of clinical and endoscopic remission (40% versus 22%, p = 0.017). The benefit of this combination therapy is both pharmacological (addition, or even synergy of the two treatments) and immunological (reduction of the risk of immunization to biotherapy).
Data on the use of immunosuppressive methotrexate treatment are divergent. Indeed, a previous randomized trial suggested that the combination of anti-TNF alpha including infliximab and methotrexate was no more effective than anti-TNF alpha monotherapy in patients with Crohn's disease. However, the superiority of this combination has been clearly demonstrated over monotherapy in rheumatology for a long time.
In practice, more and more practitioners are prescribing this combination (antiTNF and MTX) in IBD patients because of tolerance problems, particularly to azathioprine or in patients with a dual expression of their disease, both digestive and joint.
The interest of my thesis work is therefore to be able to clarify these grey areas and to be able to modify or comfort therapeutic choices in practice.
Detailed description
Data will be extracted from medical records (age, gender, smoking status, date of diagnosis of chronic inflammatory disease, date of first prescription of antiTNF alpha either infliximab or adalimumab, date of start and end of immunosuppressive azathioprine/6MP and/or metrotrexate, mode of administration of per os or SC/IV treatment, efficacy based on validated clinical scores HBI-PDAI-Mayo, tolerance). A collection will be made on the University Hospital from a computer workstation. An analysis will then be carried out to write the publication secondarily. The data retention period will be one year from November 2019 to November 2020 depending on the duration of this thesis work, which is estimated at one year.
Expected results and prospects : " Methotrexate-associated antiTNF alpha combination therapy is as effective and safe as traditional azathioprine combination therapy in patients with IBD. The positive results may in practice lead to changes in our practices and give first priority to this combination therapy with methotrexate. "
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort with TNF combination therapy | – | –Cohort with TNF combination therapy (infiximab/adalimumab) with azathiorpine |
| Cohort with anti-TNF combination therapy | – | –Cohort with anti-TNF combination therapy (infiximab/adalimumab) with methotrexate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha (infliximab, adalimumab) from January 2013 to November 2019
Key inclusion criteria (1 listed)
- Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha
Key exclusion criteria (1 listed)
- Subject unable to read
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
Evaluation of the efficacy of anti-TNF alpha and methotrexate combination therapy
Time frame: through study completion, an average of 7 years
Evaluation of the efficacy of anti-TNF alpha and methotrexate combination therapy compared to conventional azathioprine combination therapy. Efficacy is defined according to response and remission without corticosteroids based on clinical scores, biological markers, endoscopic criteria and immunization rates.
1 secondary outcome
Tolerance assessment of anti-TNF alpha and methotrexate combination therapy
Time frame: 6 months, one year, two years, and date on the latest news
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Najima BOUTA, Resident principal investigator
University Hospital, Montpellier
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 Chronic Inflammatory Bowel Disease, run by University Hospital, Montpellier 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jun 2020. 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?
Results are not available in the source record.
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?
Evaluation of the efficacy of anti-TNF alpha and methotrexate combination therapy (time frame: through study completion, an average of 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2020.