A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

Wisconsin Center for Advanced Research
2801 West Kinnickinnic River Parkway
Milwaukee, WI, 53215

Study Objective:

To assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration.

Disease Information:

Crohn’s Disease

Moderate, Severe

Study Details:

Drug Comparison:

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 Multicenter, Randomized, Double Blind, 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 CD study will include:
• A 3-Week Screening Period
• A 12-Week Double-Blind Induction 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 CD Study is 52 weeks.

Participant Criteria:

Adult (18+)

Female, Male

Patient Criteria:

Inclusion Criteria:
Between 18 and 75 years of age
Have a diagnosis of moderately to severely active Crohn’s disease for at least 90 days
Are taking certain oral corticosteroids and or immunosuppressants

For More Information: https://clinicaltrials.gov/ct2/show/NCT02065570

Center Name:

Wisconsin Center for Advanced Research

Site Location:

2801 West Kinnickinnic River Parkway, Milwaukee, WI 53215, USA
Milwaukee, WI, 53215

Principal Investigator:

Daniel Geenen

Site Coordinator(s):

Lisa Cannon
Phone: (414)-908-6630
Fax: (414)-908-6623

Jeanne Stolowski
Phone: (414)-908-6630
Fax: (414)-908-6623

Study Sponsor

Study Sponsor