Methotrexate-associated Anti-TNF Combination Therapy, the Neglected One !

NCT04196920 | Unknown

• 1 other identifier: RECHMPL19_0580
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Inflammatory Bowel Disease

Keywords

Crohn's disease; ulcerated ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Tolerance assessment of anti-TNF alpha and methotrexate combination therapy

  6 months, one year, two years, and date on the latest news

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \- Patients with chronic inflammatory bowel disease including Crohn's disease and ulcerated rectocolitis under combination therapy with anti-TNF alpha

You may not qualify if:

• Subject unable to read

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Rennes University Hospital - CHU Pontchaillou: collaborator

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Najima BOUTA, Resident

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: December 20, 2019
• Primary Completion: May 1, 2020
• Study Completion: November 30, 2020
• Last Updated: June 5, 2020

Record last verified: 2020-06

Locations

FR (1)