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

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

 

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

London - N6A 5A5

Alberta

Calgary
Edmonton

Manitoba

Winnipeg

Nova Scotia

Halifax

Ontario

London
Toronto
Vaughan

Quebec

Montreal

More information about this study

clinicaltrials.gov