NCT02065570

Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Brief summary

This study will evaluate higher versus standard active drug dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Interventional study

Status:
Completed
Conditions:
Crohn's Disease
Enrollment:
514 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-115
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 75 Years.

Inclusion Criteria:

- Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
the Screening Period.

- Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
corticosteroids and/or immunosuppressants.

- Mucosal ulceration on endoscopy.

Exclusion Criteria:

- Subject with ulcerative colitis or indeterminate colitis.

- Subject who has had surgical bowel resections in the past 6 months or is planning
resection.

- Subjects with an ostomy or ileoanal pouch.

- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.

- Subject who has short bowel syndrome.

- Chronic recurring infections or active Tuberculosis (TB).

All the cities where the clinical studies are located

Calgary - T2N 4Z6
Edmonton - T6G 2X8
Halifax - B3H 1V7
London - N6A 5A5
Sudbury - P3E 5M4
Vaughan - L4L 4Y7
Montreal - H3G 1A4
Winnipeg - R3A 1R9

Manitoba

Nova Scotia

Quebec