drugset / Trial / NCT03370601
Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.
Timeline
- Start
- 2017-01-03
- Primary completion
- 2019-01
- Completion
- 2019-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azathioprine | Small molecule | 2 mg/kg | — |
| Subject | Azathioprine | Small molecule | 2.5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 10 mg/kg | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 1 mg/kg | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 1.5 mg/kg | — |