Colitis, Ulcerative Clinical Trial
— MUNIXOfficial title:
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study
Verified date | September 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or oral prednisolone + oral azathioprine (AZA) with a more intensive and early "Top-Hold" approach with intravenous infliximab (5 mg/kg) administered at Weeks 0, 2, and 6 and 8 weeks thereafter.
Status | Terminated |
Enrollment | 28 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Any race or ethnicity - Must have a diagnosis of moderate-to-severe active ulcerative colitis (UC) with inflammation present beyond the rectum and including more than 20 cm of the colon (Mayo score of 6 to 12 points, inclusive = 2 in the endoscopy subscore) - Must have responded inadequately to oral (with or without topical) 5-ASA treatment (prerequisite oral: at a minimum 4 g/d for 7 days) and must be considered for the first course of systemic corticosteroids; Participants with a UC and a Mayo score of = 9 are also eligible without prior 5-ASA treatment - Must agree to use acceptable methods of contraception for at least 2 weeks prior to starting any study treatment and to continue until at least 6 months after the last doses of study drugs - Laboratory results must be within specified limits - Must be negative for colorectal cancer or any associated lesions - Must have a negative tuberculosis (TB) test - Must have a chest x-ray within the 3 months with no clinically significant abnormality, or evidence of current active TB or latent TB - Must have a negative stool culture Exclusion Criteria: - Pregnant, nursing, or planning pregnancy - Had received previous treatment for UC with the corticosteroids, infliximab, azathioprine/ 6-mercaptopurine (6-MP), cyclosporine, tacrolimus, methotrexate, sirolimus, mycophenolate, any tumor necrosis factor-alpha (TNF-a) inhibitor or receptor constructs that bind to ??F-a (e.g., etanercept or adalimumab) and any other biologic agents - Frequent (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs) - Use of laxatives or any murine recombinant product - Had surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage in previous 2 months - History of colonic obstruction within the previous 6 months - History of mucosal dysplasia, fistula or colonic resection, adenomatous polyps or stoma, severe, fixed symptomatic stenosis of the large or small intestine - Had serious infection with previous 2 months, including human immunodeficiency virus (HIV) and hepatitis - Had organ transplant (with the exception of a corneal transplant) - Any malignancy within 5 years, including lymphoma - History of demyelinating disease such as multiple sclerosis or optic neuritis - Presence or history of congestive heart failure - Requires chronic and frequent use of antimotility agents for control of diarrhea - Requires total parenteral nutrition - Had participated in any other clinical trial within 30 days or intention to participate in another clinical trial during participation in this study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50 | Response at Week 4 was defined as a minimum decrease from baseline in Mayo score of 3 points and 30%. Steroid-free remission at Week 50 was defined as a total Mayo score (including endoscopic assessment) of 2 points or lower and no individual subscore exceeding 1. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst). | Week 50 | No |
Secondary | Number of Participants Achieving Treatment Response | Response was defined as a minimum decrease from baseline in total Mayo score of 3 points and 30% up to and including 4 weeks after the start of treatment. The Mayo score consists of the following 4 subscores: stool frequency; rectal bleeding; endoscopy results; physician's global assessment. Each subscore is rated on a scale from 0 (best) to 3 (worst). The total Mayo score is calculated as the sum of the 4 subscores and ranges from 0 (best) to 12 (worst). |
Up to Week 4 | No |
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