Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infliximab · 2 trials · 4 indications
The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.
Will be described per American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Will be reported as a proportion together with 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Infliximab | EXPERIMENTAL | Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 and will be evaluated for the induction phase at Week 8. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion at Week 14, Week 22, and Week 30 in the maintenance phase and will be evaluated at Week 32. |
| Supportive care (Infliximab) | EXPERIMENTAL | Patients receive infliximab IV on day 1, two to four hours prior to treatment with standard of care teclistamab or talquetamab. Patients then receive teclistamab SC or talquetamab SC per treating physician discretion. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and may undergo an x-ray or PET-CT scan during screening and also blood sample collection throughout the study. |
| Name | Type | Description |
|---|---|---|
| Infliximab | DRUG | Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 for the induction phase. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion every 8 weeks up to week 32 in the maintenance phase. |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Computed Tomography | PROCEDURE | Undergo PET-CT |
| Positron Emission Tomography | PROCEDURE | Undergo PET-CT |
| Talquetamab | BIOLOGICAL | Given SC |
| Teclistamab | DRUG | Given SC |
| X-Ray Imaging | PROCEDURE | Undergo x-ray |
Inclusion Criteria: * Participant had diagnosed of definite or probable intestinal Behcet's Disease (BD) prior to Screening * Participant must have active intestinal BD, defined as; a) A baseline Disease Activity Index for intestinal Behcet's disease (DAIBD) score of greater than or equal to (\>=) ...