NCT02065622

Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Brief summary

To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

Interventional study

Status:
Completed
Conditions:
Ulcerative Colitis (UC)
Enrollment:
952 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M14-033
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 Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
during Screening period.

- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
concurrent or prior treatment with a full and adequate course, in the opinion of the
Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is
confirmed by central reader.

Exclusion Criteria:

- Subject with Crohn's disease (CD) or indeterminate colitis (IC).

- Current diagnosis of fulminant colitis and/or toxic megacolon.

- Subjects with disease limited to the rectum (ulcerative proctitis) during the
screening endoscopy.

- 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
Toronto - M5G 1X5
Vaughan - L4L 4Y7
Montreal - H3G 1A4
Winnipeg - R3A 1R9

Manitoba

Nova Scotia

Quebec