| Conditions |
Ulcerative colitis, crohn's disease, rheumatoid arthritis, psoriatic arthritis, or ankylosis spondylitis Not Applicable Ulcerative colitis, Crohn's disease, rheumatoid arthritis, psoriatic arthritis, or ankylosis spondylitis |
| Interventions |
This study will aim to recruit participants with inflammatory bowel disease or inflammatory arthritis who are being treated with intravenous (IV) infliximab as part of their routine clinical care. Participants will be switched from IV infliximab to a self-administered subcutaneous injection of 120 mg/ml infliximab biosimilar (CT-P13) every 2 weeks for a duration of 24 weeks. The first subcutaneous injection will be given when the patient is scheduled to receive their next dose of IV infliximab. Training will be provided and the first dose will be administered under supervision. Thereafter subcutaneous CT-P13 will be self-administered every 2 weeks by the subject in their home. Potential participants will be sent the patient information sheet by post, email, or another contact with the clinical or research team up to 24 h prior to enrolment. The patients will be given adequate time to consider the trial information before being asked to sign the informed consent form. Patients who do not wish to take part in the study will be given the opportunity to take part in the semi-structured qualitative interviews to capture their reasons for not participating. Participants will be assessed at a screening visit and 3 further visits. Baseline (screening) visit At the screening visit, the investigator will go through the inclusion and exclusion criteria and ensure that the patient is eligible to proceed. The patient will be fully informed of all aspects of the trial, the potential risks, and their obligations. The aims of the study and all tests to be carried out will be explained. The patient will be given the opportunity to ask any questions that they have and will then have time |