Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remissio

• Conditions: chronic inflammatory bowel disease; Crohn's disease; 10017969; 10003816

• Registration Number: NL-OMON32054
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 128

Inclusion Criteria

- age > 18
- At least 6 months a stable dose of combination therapy with IFX and AZA or with AZA and 6MP
- Crohn's Disease in remission (defined by a CDAI lower than 150 points) for at least 6 months

Exclusion Criteria

- Abdominal abscesses, fistulas and fluid collections
- Co morbidity or extra-intestinal complications that require infliximab treatment
- Crohn's disease activity of the upper gastrointestinal tract that requires infliximab treatment
- Age > 80 years
- Legally incompetent patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The occurrence of relapse - defined as a disease activity with a CDAI score<br /><br>greater than 150 - during the 12 months follow-up period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Presence of mucosal healing at 12 months<br /><br>2. Number of treatment failures during the 12 months follow-up period<br /><br>3. Time to relapse<br /><br>4. The patients' level of health related quality of life (HROQL) at the end of<br /><br>the study period, assessed by the IBDQ questionnaire</p><br>