NL1344.

Trial name or title	Azathioprine maintenance treatment versus infliximab maintenance treatment in Crohn’s disease patients in remission (Azorix trial)
Methods
Participants	Inclusion criteria: 1. Age between 18 and 80 years 2. For at least 6 months a stable dose of combination therapy with IFX and AZA or with IFX and 6MP 3. CD in remission for at least 6 months Exclusion criteria: 1. Failed attempt to quit medication during combination therapy before 2. Abdominal abscesses, fistulas and fluid collections 3. Comorbidity or extra‐intestinal complications that require infliximab treatment 4. Crohn’s disease activity of the upper gastrointestinal tract that requires infliximab treatment 5. Legally incompetent patients
Interventions	Two arms. Arm 1:Infliximab consisting of infusions of 5 mg/kg. Patients will receive maintenance therapy at intervals of 6 to 12 weeks Arm 2: Azathioprine in a dose of 2.5 mg/kg daily; 6‐MP will be continued in a dose of 1.5 mg/kg daily
Outcomes	Primary outcome: The occurrence of relapse ‐ defined as a disease activity with a CDAI score greater than 150 ‐ during the 12 months follow‐up period. Secondary outcome:Mucosal healing at 12 months; Number of treatment failures after 12 months; Time to relapse; HRQOL at 12 months, measured by IBDQ
Starting date	1st August 2008
Contact information	Dr. P.C.F. Stokkers; p.stokkers@amc.nl
Notes