Investigating the need to continue taking immunomodulator tablets for patients with inflammatory bowel disease, when switching from treatment with intravenous infliximab infusions (infliximab given directly into a vein) to subcutaneous infliximab (infliximab given by an injection under the skin).
- Conditions
- Crohn's disease and ulcerative colitisDigestive System
- Registration Number
- ISRCTN95420128
- Lead Sponsor
- Kings Health Partners
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 102
1. Aged 18 years and over
2. Diagnosis of Crohn’s disease, ulcerative colitis or IBD-U for at least 6 months at the time of commencement of SC CT-P13
3. A clinical decision has been made to switch from intravenous infliximab to SC CT-P13
4. On stable IV infliximab at 5mg/kg Q8W for at least 22 weeks at the time of commencement of SC CT-P13
5. On azathioprine or mercaptopurine for at least 3 months, at a stable dose for at least 4 weeks at the time of commencement of SC CT-P13
6. Clinical remission defined by HBI =4 or SCCAI =2 at screening
7. Infliximab levels above or equal to the lower therapeutic level (as per local lab) at the time of the final or penultimate IFX infusion
8. Written informed consent to participate
9. Sufficient English to understand the study and sign informed consent, or available local interpreting service
1. Not willing or able to switch to subcutaneous (SC) treatment
2. Evidence of clinically active severe infections such as, bacterial sepsis, active viral infection and opportunistic infections. Severity as judged by the investigator
3. Any clinically significant test results that in the opinion of the investigator should exclude the participant
4. In the opinion of the investigator, patient in whom withdrawal of the thiopurine would not be appropriate
5. Known allergy/ hypersensitivity/ intolerance to the active substance or excipients, or patients taking any medications which are contraindicated as per the IMPs SmPCs
6. Participation in an investigational trial that involves ongoing treatment with an investigational medicinal product at baseline
7. Pregnant women and women of child bearing potential who are planning to get pregnant during the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method