Methotrexate to suppress immunogenicity to anti-tumor necrosis factor therapy in IBD patients with loss of response

Withdrawn

• Conditions: 10017969; Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis); 10003816

• Registration Number: NL-OMON48064
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• 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 AU/ml) using a drug-sensitive assay
- Sub-therapeutic IFX or ADL serum levels (IFX <3 µg/mL, ADL<5 µg/mL)

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A composite primary endpoint will be used: i.e. percentage of patients with:<br /><br>• Complete disappearance of measurable ADA,<br /><br>AND<br /><br>• Measurable IFX or ADL serum concentrations within 6 months after starting MTX</p><br>