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MUNIX: Infliximab Top-Hold vs Step-Up in Ulcerative Colitis
NCT00984568Phase 3
Key facts
- Status
- Terminated
- Start
- Nov 2009
- Primary completion
- Mar 2012
- Sponsor
- Merck & Co.
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 3, randomised, open-label trial of infliximab in ulcerative colitis (UC) (2 arms), sponsored by Merck & Co. Primary endpoint: Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50. Started Nov 2009; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Top-Hold
Early Infliximab monotherapy with escalation to intensified Infliximab or switch to Prednisolone+AZA.
Step-Up
Conventional Step-Up: Prednisolone+5-ASA -> Prednisolone+AZA -> Infliximab.
03
Who it enrols
Patients with moderate-to-severe active ulcerative colitis (Mayo score 6-12) who have responded inadequately to oral 5-ASA. Excludes patients with prior biologic or immunomodulator therapy.
04
Endpoints
Primary
Number of Participants With Response at Week 4 and Steroid-Free Remission at Week 50
Secondary
Number of Participants Achieving Treatment Response
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