Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety of adalimumab for treatment of patients
      with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on
      patient general well-being, health-related quality of life (QoL), fistula healing, CD-related
      extra-intestinal manifestations, work performance, and overall activity.
    

Detailed description: 
      This is an open-label, multi-center, study designed to evaluate the safety and efficacy of
      adalimumab on inducing and maintaining clinical remission in subjects with moderate to severe
      Crohn's Disease.

      Approximately 1000 subjects with a diagnosis of moderate to severe Crohn's Disease (Harvey
      Bradshaw Index score >= 7) will be enrolled at approximately 200 sites within Europe.
      Enrollment will be dependent on meeting all screening criteria.

      Study medication will be administered by subcutaneous injection. At Baseline (Week 0), all
      subjects will receive a dose of 160 mg adalimumab. At Week 2, all subjects will receive a
      dose of 80 mg adalimumab. Starting at Week 4, all subjects will begin receiving injections of
      adalimumab 40 mg every other week and will continue every other week dosing through Week 20
      except in the case of disease flare or non-response.

      Starting at Week 12, subjects who experience a disease flare (flare is defined by an increase
      in the Harvey Bradshaw Index >=3 and a total Index score of >=7 when compared to Week 4) or
      are not responding to adalimumab treatment (non-response is defined as a decrease in the
      Harvey Bradshaw Index by fewer than 3 points compared to Baseline) will be permitted to
      increase study therapy to adalimumab 40 mg every week.

      If the subject continues to demonstrate a lack of improvement on every week adalimumab
      therapy, they may be withdrawn from the study.

      Prior to Week 8 subjects will not be allowed to increase or decrease Crohn's specific
      concomitant medications except in the event of concomitant Crohn's treatment-related
      toxicities assessed as moderate to severe. Changes in concomitant medications at/after Week 8
      will be at the Investigator's discretion.

      Subjects will be evaluated for safety and efficacy at Baseline (Week 0), Weeks 2, 4, 8, 12,
      and 20, and at unscheduled visits. Efficacy evaluations include HBI, Short Inflammatory Bowel
      Disease Questionnaire (SIBDQ), Work Productivity Activity Index (WPAI) questionnaire, fistula
      counts, health care resource utilization (HCRU), and evaluation of CD-related
      extra-intestinal manifestations (EIMs). Safety assessments include vital signs, physical
      examination, general laboratory analyses, urinalysis, and monitoring of adverse events (AEs).
    

Intervention name(s): adalimumab; adalimumab
Intervention type(s): Biological; Biological
Intervention description(s): Adalimumab 40 mg Every Other Week dosing; Adalimumab 40 mg Every Week dosing if participant experiences a disease flare or is not responding to treatment. A disease flare is defined as an increase of 3 points or more on the HBI compared to the Baseline score and a total HBI score of 7 or higher. Non-response is defined as a decrease by fewer than 3 points in the HBI compared to Baseline.
Other intervention name(s): Humira; Humira
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment