Adalimumab for the Management of Post-operative Crohn's Disease (CD)

Sponsor
Tel-Aviv Sourasky Medical Center
Study ID
NCT01629628
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study.
  • 6 Mercaptopurine — DRUG
    6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg. \--------------------------------------------------------------------------------

Study Details

This study will be a prospective, open label, randomized, comparative study. Comparing the efficacy of adalimumab with immunomodulator therapy (i.e. 6-mercaptopurine, 6-MP), in maintaining remission of post-operative CD patients, with a high risk of disease recurrence. Patient assessment for efficacy will be conducted through interval endoscopic surveillance at 24 and 52 weeks. Patients in the adalimumab arm, showing endoscopic remission at 52 weeks of therapy, will be re-randomized to either maintain adalimumab therapy for an additional 52 weeks or conclude therapy. A third endoscopic assessment for these patients will be conducted at 104 weeks. The investigators expect a substantial increase in both endoscopic, as well as clinical remission rate in patients on adalimumab therapy.

Key Dates

Start date
Jul 31, 2012
Status verified
Jun 2012
Primary completion
Jul 31, 2016
Completion
Jul 31, 2016

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Adalimumab
  • Active Comparator: 6-mercaptopurine

Primary Outcome Measure

The proportion of patients with endoscopic recurrence at 12 months, as evaluated by the Rutgeerts endoscopic scoring system. [ Time Frame: 52 weeks ]

Central Contacts

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