Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
Recruiting in Palo Alto (17 mi)
+107 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Abbott
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).
Research Team
RB
Roopal B Thakkar, M.D.
Principal Investigator
Abbott
Eligibility Criteria
Inclusion Criteria
Participants >=18 years of age and in good health (Investigator discretion) with a recent stable medical history
Diagnosis of UC for greater than 90 days prior to Baseline
Diagnosis of active UC confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection
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Treatment Details
Interventions
- Adalimumab (Monoclonal Antibodies)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: placebo groupExperimental Treatment1 Intervention
Group II: adalimumab groupExperimental Treatment1 Intervention
Adalimumab is already approved in Canada, Japan for the following indications:
Approved in Canada as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Approved in Japan as Humira for:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Juvenile idiopathic arthritis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Site Ref # / Investigator 3743Nashville, TN
Site Ref # / Investigator 3758Jacksonville, NC
Site Ref # / Investigator 10423Kelowna, Canada
Site Ref # / Investigator 3768Montreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Abbott
Lead Sponsor
Trials
760
Patients Recruited
489,000+