Status:
TERMINATED
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Colitis, Ulcerative
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-amino...
Detailed Description
Participants will be randomized to receive either intravenous (IV) infliximab monotherapy (Top-Hold approach) starting at a dose of 5 mg/kg at Weeks 0, 2, and 6 and thereafter every 8 weeks in Level 1...
Eligibility Criteria
Inclusion
- 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
- 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-α) inhibitor or receptor constructs that bind to ΤΝF-α (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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00984568
Start Date
November 1 2009
End Date
March 1 2012
Last Update
April 13 2017
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