Crohn's disease and ulcerative colitis Digestive System
Conditions
Interventions
The intervention is the withdrawal of immunomodulators (azathioprine or mercaptopurine) in IBD patients switching from IV infliximab to subcutaneous infliximab (SC CT-P13). Participants will be rando
Sponsors
Kings Health Partners
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Free antibody positivity (i.e. =10 ng/mL) measured using blood sample analysis at week 24 in patients continuing and discontinuing thiopurines after switching from IV infliximab to SC CT-P13 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Infliximab drug levels measured using blood sample analysis at weeks 8, 16 and 24 in participants continuing and discontinuing immunomodulators after switching from IV infliximab to SC CT-P13 2. Total anti-drug antibodies measured using blood sample analysis at weeks 8, 16 and 24 and free anti-drug antibodies at weeks 8 and 16 in participants continuing or discontinuing immunomodulators after switching from IV infliximab to SC CT-P13 3. Anti-drug antibody positivity (free and total) measured using blood sample analysis by week 24 in participants continuing or discontinuing immunomodulators after switching from IV infliximab to SC CT-P13 4. Efficacy of therapy by week 24/ Early termination measured using the proportion of participants developing clinically active disease (HBI> 4 or SCCAI>2), biochemically active disease (CRP >5 mg/l and/or faecal calprotectin >250mcg/g), and both clinically and biochemically active disease, in participants continuing or discontinuing immunomodulators after switching from IV infliximab to SC CT-P13 5. Tolerability of treatment through to week 24/ Early termination measured as the rate of AE and SAEs in participants continuing or discontinuing immunomodulators after switching from IV infliximab to SC CT-P13 6. Quality of life in participants switching from IV to SC treatment at Week 24/ Early Termination, regardless of randomisation allocation, measured using the IBD-Control Questionnaire. 7. Proportion of participants having to revert back to IV in each randomisation arm measured using data collected at each visit 8. Acceptability of switching from IV to SC treatment measured using a treatment acceptability questionnaire at week 24/ Early termination 9. Infliximab drug levels and anti-drug antibodies positivity measured using blood sample analysis at weeks 8, 16, and 24 in participants with positive and negative HLA DQA1*05, regardless of randomisation allocation 10. Infliximab drug levels and anti-drug antibodies positivity mea | — |
Countries
United Kingdom
Contacts
Public ContactAlima Rahman
Outcome results
None listed