Methotrexate-associated Anti-TNF Combination Therapy, the Neglected One !
MTX
MTX
Sponsor study identifier
observational
200
1 country
1
Study Start
December 20, 2019
Actual (reported)Primary Completion
May 1, 2020
Actual (reported)Study Completion
November 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2019
Actual (reported)December 12, 2019
Actual (reported)December 20, 2019
Actual (reported)May 1, 2020
Actual (reported)November 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
through study completion, an average of 7 years
Tolerance assessment of anti-TNF alpha and methotrexate combination therapy
6 months, one year, two years, and date on the latest news
Cohort with TNF combination therapy (infiximab/adalimumab) with azathiorpine
Cohort with anti-TNF combination therapy (infiximab/adalimumab) with methotrexate
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
Uhmontpellier
Montpellier, 34295, France
Najima BOUTA, Resident
University Hospital, Montpellier
200 participants (actual enrollment reported by the registry).
First Submitted
December 4, 2019
First Posted
December 12, 2019
Study Start
December 20, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 1, 2020
Actual (reported)Study Completion
November 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 5, 2020
Record last verified: 2020-06
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Source: ClinicalTrials.gov.
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