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This study will be performed to directly compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate to severe active ulcerative colitis using prednisolone and 5-aminosalicylic acid (5-ASA) and oral Azathioprine (AZA) with a more intensive and early "Top-Hold" approach with infliximab (5 mg/kg) continuously given every 8 weeks following induction at weeks 0, 2, and 6.
Investigational Medical Product: Infliximab at 5 mg/kg body weight intravenously (IV) for induction and maintenance treatment given at week 0,2,6, followed by q8w (Level 1) and q4w (Level 2) weeks through week 46. Non responders in Level 2 will be switched to prednisolone combined with AZA (oral Azathioprine) (Level 3).
Reference Products: Level 1: Oral prednisolone (40 mg/day or 1mg/kg/day in case of non-response) and oral 5-ASA (2 g/day); Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in case of non-response) and oral AZA at a dose of 2.0 - 2.5 mg/kg/day. Non-responders in Level 2 will enter Level 3: Infliximab at 5 mg/kg. The reference therapy in Levels 1 and 2 will be administered daily up to week 50, or in Level 3 infliximab q8w through week 46.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Infliximab, Prednisolone, 5-aminosalicylic acid (5-ASA), Azathioprine (AZA)
Investigational Site 44
Published on BioPortfolio: 2014-08-27T03:19:04-0400
OBJECTIVES: I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start Azathioprine (...
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies. However, there are no data investigating whether the additi...
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
Azathioprine is considered first line immunomodulatory therapy for patients with ulcerative colitis. Up to 50% are treatment failures or experience adverse events leading to treatment with...
5-Aminosalicylic acids (5-ASA) are effective for ulcerative colitis (UC) as a maintenance therapy. It is not clear when and how to reduce a dose of 5-ASA after inducing remission. We aimed to investig...
Infliximab is effective in patients with ulcerative colitis (UC); however, one-third of patients do not respond and require additional therapies such as other biologic agents. Therefore, the aim of th...
Acute severe ulcerative colitis (ASUC) is a potentially life-threatening condition that requires early recognition, hospitalization and adequate treatment. Currently, the use of infliximab in ulcerati...
Diverticular disease is a common condition that increases in prevalence with age. Recent theories on the pathogenesis of diverticular inflammation have implicated chronic inflammation similar to that ...
Outcomes of acute severe ulcerative colitis (ASUC) appear dependent on early intervention with the first and/or further infliximab(IFX) doses, though parameters to guide decision-making remain uncerta...
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.
Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.
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.