A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
To evaluate the efficacy and safety of two adalimumab induction regimens in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
The study drug:
Mechanism of action:
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also modulates biological responses that are induced or regulated by TNF.
Overview of Study Design(blinded, placebo-controlled, etc.)
A Double-Blind, Randomized, Multicenter Study, Phase III
Possible Risks and Side Effects:
Adalimumab can cause serious side effects, including:
• Serious infections including tuberculosis
• Cancer for example skin cancer or lymphoma
• Hepatitis B infection in carriers of the virus
• Allergic reactions
• Nervous system problems
• Blood problems
• Heart failure
• Immune reactions including a lupus-like syndrome
• Liver problems
• Psoriasis (new or worsening)
Common side effects of adalimumab include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with adalimumab. Tell your doctor if you have any side effect that bothers you or that does not go away.
If you have any questions about potential risks or side effects please ask the study doctor.
Explanation of Participation:
The UC study will include:
• A 3-Week Screening Period
• An 8-Week Double-Blind Induction Period
• A 44-Week Double-Blind Maintenance Period
• A 70-Day Follow-Up Period
Patients will receive study-related procedures and study drug at no cost. Additionally, patient will receive monitoring by the study doctor and staff for the duration of the study.
Observation Period:The total observation period for the Serene UC study is 65 weeks.
Between 18 and 75 years of age
Have a diagnosis of moderately to severely active ulcerative colitis for at least 90 days
Are taking certain oral corticosteroids and or immunosuppressants
Wisconsin Center for Advanced Research
2801 West Kinnickinnic River Parkway #1030, Milwaukee, WI 53215, USA
Milwaukee, WI, 53215