None listed
Conditions
Interventions
None listed
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) Patients with inflammatory bowel disease (active Crohn's disease or ulcerative colitis) currently receiving maintenance therapy with intravenous infliximab who have been determined to switch to subcutaneous administration. 2) Patients who have maintained a steroid-free status for at least 6 months and meet the criteria for clinical remission: - Active Crohn's Disease: CDAI (Crohn’s Disease Activity Index) score < 150 - Ulcerative Colitis: Partial Mayo Score = 2 3) Patients aged 19 to 74 years. 4) Individuals who have voluntarily provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) Patients who have received intravenous infliximab for less than 6 months prior to study enrollment. 2) Patients with a history of hypersensitivity to humanized proteins. 3) Patients with active tuberculosis; however, those with a history of tuberculosis who have been successfully treated according to standard tuberculosis treatment guidelines and can provide proof of complete resolution may be eligible. 4) Patients with latent tuberculosis; however, those who have completed 3 weeks of treatment for latent tuberculosis and plan to complete treatment may be eligible. 5) Patients with active hepatitis B or C (confirmed through medical history). 6) Patients with a history of HIV infection or who test positive for HIV (confirmed through medical history). 7) Patients with NYHA Class III/IV heart disease. 8) Patients with a history of serious infections or malignancies within the past 5 years (excluding basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma) or a history of dysplasia of the colon or small intestine within the past 5 years. 9) Patients deemed unsuitable for study participation at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of subjects meeting the relapse criteria and the number of relapses among patients switched from intravenous infliximab to subcutaneous infliximab in each group [Assessment Time Point: 48 weeks] [Criteria for Relapse] - Active Crohn's Disease: CDAI score = 150 - Ulcerative Colitis: Partial Mayo Score > 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the proportion of subjects meeting the relapse criteria in each group of patients switched from intravenous infliximab to subcutaneous infliximab.;Change in Endoscopic Scores Compared to Baseline;Minimum Serum Concentrations and Anti-Drug Antibody Formation Rates;Laboratory Test Results (CRP/Albumin);Fecal Test Results (Fecal Calprotectin);Safety Assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactKANG MOON LEE
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed