Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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-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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aminosalicylic Acid; Azathioprine; Infliximab; Mesalamine; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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-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