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

Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission - Azorix trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32054

Enrollment

128

Registered

2008-04-04

Start date

2008-06-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic inflammatory bowel disease Crohn's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The occurrence of relapse - defined as a disease activity with a CDAI score greater than 150 - during the 12 months follow-up period.	—

Secondary

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

Countries

Netherlands

Outcome results