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The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.
A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cedars-Sinai Medical Center
Published on BioPortfolio: 2014-07-24T14:34:14-0400
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab...
The purpose of this study is to assess the efficacy, immunogenicity, and safety of various doses of visilizumab in subjects with intravenous steroid-refractory ulcerative colitis (IVSR-UC)...
The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. What is visil...
The purpose of this study is to compare the efficacy of visilizumab to placebo in subjects with intravenous steroid-refractory ulcerative colitis.
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received...
Inflammatory bowel disease (IBD) is commonly divided into 2 entities: Crohn's disease (CD) and ulcerative colitis (UC). Differentiating between these entities when dealing with IBD confined to the col...
Oral drug delivery is the most attractive pathway for ulcerative colitis (UC) therapy, since it has many advantages. However, this strategy has encountered many challenges, including the instability o...
Data on the efficacy of intercellular adhesion molecule-1 antisense oligonucleotide alicaforsen in ulcerative colitis (UC) is inconsistent.
Patients considering surgery for ulcerative colitis (UC) face a difficult decision as surgery may or may not improve quality of life. National Institute for Health and Care Excellence guidelines for U...
Patients with ulcerative colitis often report fatigue.
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.
An acute form of MEGACOLON, severe pathological dilatation of the COLON. It is associated with clinical conditions such as ULCERATIVE COLITIS; CROHN DISEASE; AMEBIC DYSENTERY; or CLOSTRIDIUM ENTEROCOLITIS.
A humanized monoclonal antibody that binds specifically to TNF-ALPHA and blocks its interaction with endogenous TNF RECEPTORS to modulate INFLAMMATION. It is used in the treatment of RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS; CROHN'S DISEASE and ULCERATIVE COLITIS.
A surgical procedure involving the excision of the COLON and RECTUM and the formation of an ILEOANAL RESERVOIR (pouch). In patients with intestinal diseases, such as ulcerative colitis, this procedure avoids the need for an OSTOMY by allowing for transanal defecation.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...