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CONNECT-IBD observational study of CT-P13 in inflammatory bowel disease
2014-005192-89Phase 4
Key facts
- Status
- Completed
- Start
- Apr 2015
- Countries
- 1
- Sponsor
- Hospira, Inc.
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- infliximab-dyyb
- Conditions
- inflammatory bowel disease (IBD)Crohn's diseaseautoimmune colitis
01
Overview
Phase 4, open-label, single-arm trial of infliximab-dyyb in inflammatory bowel disease (IBD), Crohn's disease and autoimmune colitis, sponsored by Hospira, Inc. Primary endpoint: Patients' demographic characteristics. Started Apr 2015; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CT-P13 observational cohort
Single non-randomized observational cohort of patients treated with CT-P13 in routine care.
03
Who it enrols
Adult patients enrolled at age 18 years or older with confirmed Crohn's disease or ulcerative colitis; diagnosis must have been established at age 12 years or older. Excludes patients with contraindications to CT-P13 or Remicade.
04
Endpoints
Primary
Patients' demographic characteristics
Secondary
Clinical assessment of disease activity
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