Open Label Extension Study to Protocol C2/13/DR-6MP-02
Status:
Withdrawn
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
The open label extension study (Protocol C2/13/DR-6MP-02 EXT) is designed to evaluate the
clinical efficacy and safety of 80 mg DR-6MP test formulation for an additional 12 weeks in
subjects who already completed 12 weeks of Protocol C2/13/DR-6MP-02. Crohn's disease (CD)
therapy is aimed at reducing inflammation via induction of remission after a flare-up and
maintenance of the remission for as long as possible. The questions being asked in this
extension study are:
1. For subjects who received 80 mg DR-6MP for 12 weeks: Can the clinical efficacy and
safety status achieved following 12 weeks of treatment be maintained or improved
following an additional 12 weeks of DR-6MP treatment?
2. For subjects who received oral Purinethol (1-1.5 mg/kg daily) for 12 weeks: Can the
clinical efficacy and safety at 12 weeks be maintained or improved following the
introduction of 12 weeks of 80 mg DR-6MP treatment?