The effects of switching one drug, used to treat either Ulcerative Colitis (UC) or Crohn’s disease (CD) to another drug, also used to treat UC or Crohn’s disease
- Conditions
- Inflammatory Bowel Disease in particular Crohn's Disease and Ulcerative ColitisMedDRA version: 20.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-001546-33-GB
- Lead Sponsor
- niversity Southampton Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
The principal inclusion criteria are;
•All patients with IBD (Crohn’s Disease and Ulcerative Colitis) treated with =1 dose of CT-P13 at time of enrolment
•Aged =18 years at time of enrolment
•Planned continuation of infliximab treatment for at least 3 months after enrolment
•Capable of providing written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Patients with the following characteristics are ineligible for this study
• Unable to provide written informed consent
• Involved in another IMP trial
• Age < 18 years at time of enrolment
• Planned discontinuation of treatment at UHS within 3 months of enrolment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method