Addition of methotrexate to regain clinical response in IBD patients on anti-TNF therapy

Phase 1

• Conditions: Inflammatory bowel disease: Crohn's disease and Ulcerative colitis; MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-003594-95-NL
• Lead Sponsor: Amsterdam UMC location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

-Age = 18 years (both men and women)
-Confirmed diagnosis of CD or UC by endoscopy and histopathology
-Maintenance therapy with IFX or ADL, with or without thiopurines (i.e. azathioprine or mercaptopurine)
-Loss of response, defined by clinical parameters (i.e. HBI> 4 points (CD), SCCAI> 5 points (UC), and/or patients with actively draining perianal fistula (CD)) and/or with elevated inflammatory biomarkers (i.e. serum CRP > 5 mg/l and/or fecal calprotectin > 250 mg/kg))
-Detectable anti-drug antibodies (ADA) directed against IFX or ADL (>12 AE/ml) using a drug-sensitive assay

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-Prior intolerance to MTX
-Pregnancy or planned pregnancy in the coming year (men and women)
-Patients with total bilirubin, alkaline phosphatase, gamma-glutamyl transferase, AST or ALT of more than 2 times the upper limit of normal
-Subjects with evidence of or suspected liver disease, such as primary sclerosing cholangitis or cirrhosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified