Santarus, Inc. (NASDAQ: SNTS) today announced the completion of enrollment in the CONTRIBUTE clinical study designed to evaluate the incremental benefit of adding UCERIS ® (budesonide) extended release 9 mg tablets to oral aminosalicylate (5-ASA) therapy for the induction of clinical remission in adult patients with active, mild to moderate ulcerative colitis. UCERIS is currently approved in the U.S. for the induction of remission in patients with active, mild to moderate ulcerative colitis.
A total of 509 patients were enrolled in the CONTRIBUTE study, a multicenter, randomized, double-blind, placebo controlled clinical trial. The primary endpoint of the study is clinical remission, defined as a score of 0 for both rectal bleeding and stool frequency on the Ulcerative Colitis Disease Activity Index (UCDAI) scale. All patients were randomized to either the UCERIS or placebo arm and will continue their existing background 5-ASA regimen during the 8 week study.
“We believe the data from this combination study will provide valuable information for physicians who treat patients with active ulcerative colitis,” said Wendell Wierenga, Ph.D., executive vice president of research and development. “We expect to have top-line data from the study available by year-end, and plan to release expanded study results at an appropriate medical meeting in 2014.”
UCERIS Indication and UsageUCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. Dosage and Administration UCERIS is taken once daily in the morning with or without food for up to 8 weeks. Important Safety Information
- Do not take UCERIS if you are allergic to budesonide or any of the ingredients in UCERIS.
- Before you take UCERIS, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
- Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other causing side effects.
- Do not eat grapefruit or drink grapefruit juice while taking UCERIS because these can increase the level of UCERIS in your blood.
- Long-time use of UCERIS can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
- When UCERIS is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS, including tiredness, weakness, nausea and vomiting, and low blood pressure.
- UCERIS weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
- If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to UCERIS may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking UCERIS.
- The most common side effects with UCERIS are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.