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Crohn's Disease

Protocol CNTO1275CRD3002

 

UNITI 2

 

Enrollment Status: OPEN

 

Drug: Ustekinumab (Stelara®) – intravenous (IV) infusion and subcutaneous (SC) injection

 

Stelara is a medicine that blocks the activity of a protein in your body called interleukin 12/23. This protein is thought to be important in causing inflammation and therefore may play a major role in diseases like Crohn's disease and ulcerative colitis. It has already been tested and approved to treat psoriasis and psoriatic arthritis. Stelara showed promising results in previous phase II studies of patients with Crohn's disease who had not done well while taking medicines available on the market. This study, which is the next one in the series, will evaluate the effectiveness of IV infusion (given through a vein) and/or injection (given under the skin) doses of Stelara in helping to reduce symptoms in patients with moderately to severely active Crohn's disease.

 

Appointments are at screening, week 0 (IV infusion), week 3, week 6, and week 8. If you complete this 8-week study, you will have the option to join the maintenance phase of the study, which will allow access to the drug for up to 4 years. This will involve returning to the site every 4 weeks for an injection under the skin. You will be reimbursed for time and travel for each completed appointment.

 

 

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