Crohn's disease MedDRA version: 7.1 Level: Low Classification code 10011401
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with a diagnosis of CD, clinically confirmed either by radiological endoscopic or histological examination (radiology, endoscopy and/or biopsy do not have to be repeated for the study if done within five year prior study start unless the study physician wants a confirmation of the diagnosis). • Patients with active CD as defined by CDAI > 220 and CDAI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients having had oral, i.v. or rectal administration of steroids before day -14 prior to randomization • Patients who underwent gastrointestinal surgery in the last 3 month or requiring GI surgery at the time of Screening/Baseline. • Patients with history of extensive bowel surgery that may impair absorption (i.e., resection of >100 cm of small bowel) • Patients who have strictures with pre-stenotic dilatation as demonstrated in appropriate radiographic studies. The radiography to be performed only in patients with clinical symptoms of strictures. • Patients with fistulizing disease if this represents the major complication for the patient. • Treatment with 6-mercaptopurine, azathioprine, methotrexate, ciclosporine or anti-TNF? antibodies in the last 3 months prior to Screening/Baseline. • Known allergy or intolerance to AZA or 6-mercaptopurine. • Patients with a positive stool culture for enteric pathogens, pathogenic ova or parasites or clostridium difficile toxin. • Concurrent malignancy or history of malignancy except for successfully treated localized basal or squamous cell carcinoma of the skin. • Concurrent bowel dysplasia or a history of bowel dysplasia in five years prior to Screening/Baseline. • Patients with any clinically significant unstable condition as assessed by the principal investigator at each site. • Patients with hepatic cirrhosis or liver function tests AST (SGOT), ALT (SGPT), or alkaline phosphatase greater than twice the upper limit of the normal range at Screening/Baseline. • Patients with a serum creatinine greater than 1.7 mg/dL (150 µmol/L) at Screening/Baseline. • Patients with white blood cell (WBC) count <3,500/mm3, lymphocyte count <800/mm3 at Screening/Baseline. • Presence of severe hypercholesterolemia (? 350mg/dL, 9.1 mmol/dL)) or hypertriglyceridemia (? 500mg/dL, 5.6 mmol/L). Patients with controlled hyperlipidemia are acceptable • Patients known to be HIV antibody, hepatitis B surface antigen, or hepatitis C antibody positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of RAD001 in CD patients by testing the hypothesis that RAD001 6 mg/day QD is superior to AZA in maintaining patients in steroid-free remission throughout the following co-primary objectives: 1. To compare the proportion of patients in RAD001 and AZA arms who, after achieving remission within 3 months, maintained steroid- free remission for a minimum of 9 months (from end month 3 to end month 12). 2. To compare the proportion of patients in RAD001 and placebo arms who, after achieving remission within 3 months, maintained steroid-free remission for a minimum of 9 months (from end month 3 to end month 12). 3. To assess safety of RAD001 in CD patients. ;Secondary Objective: To assess : 1. the time to relapse in all treatment groups. 2. the steroid sparing effect of RAD001 compared to AZA. 3. the remission rate at end of month 3 in all treatment groups. 4. the time to onset of remission in all treatment groups. 5. the time to onset of response in all treatment groups. 6. the response rate at the end of week 6 of treatment. 7. the mean CDAI scores at specified time points in all treatment groups. 8. the effects of RAD001 and AZA on inflammatory markers (CRP and fecal calprotectine) of disease activity. 9. the quality of life in all treatment groups. 10. pharmacokinetics of RAD001. 11. whether stopping RAD001 has a rebound effect. 12. To perform exploratory pharmacogenetic assessments ;Primary end point(s): The primary efficacy variable is the proportion of patients with treatment success. This proportion will be calculated in each treatment arm. The primary efficacy variable is derived by combining several assessments. Patients with treatment success (used as nominator in the proportion) are those who: • achieved steroid-free remission by the end of Months 3 • maintained steroid- free remission for a minimum of 9 months (from the end of Month 3 to the end of Month 12) • didn’t use any prohibited efficacy related treatment | — |
Countries
Slovakia
Outcome results
None listed