Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication REMICADE is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. FDA label
Also known as Avakine, cA2, Remicade, Remsima
Infliximab · 4 trials · 6 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.
At Week 8, clinical response is defined as a decrease from baseline (closest measurement taken prior to or at the time of the initiation of the baseline \[Week 0\] infusion) in the Mayo score by ≥30% and ≥3 points, with a decrease in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1, at Week 8.
The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.
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. |
| Group I: Placebo | PLACEBO_COMPARATOR | Participants in Group I receive placebo |
| Group II: Infliximab | EXPERIMENTAL | Participants in Group II receive 5 mg/kg infliximab |
| Placebo | EXPERIMENTAL | Placebo infusion, matched to infliximab will be given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants will receive 5 mg/kg infliximab intravenously. Placebo infusion will be again given at Week 14 and 22. Total duration of treatment will be 26 weeks. |
| 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. |
| Placebo | DRUG | Form = solution for injection, route = IV, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with placebo through Week 22 will receive infliximab at Weeks 32, 34, 38, 46 and 54 and will receive placebo at Week 30. |
| 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 (\>=) ...
Infliximab is studied in Behcet disease, cytokine release syndrome, psoriasis, and ulcerative colitis. It is being evaluated for cytokine release syndrome prophylaxis in patients receiving teclistamab or talquetamab for relapsed or refractory multiple myeloma, and in moderate-to-severe refractory intestinal Behcet's disease, active ulcerative colitis, and moderate to severe plaque-type psoriasis.
Infliximab targets TNF, tumor necrosis factor. It is a monoclonal antibody that acts as a TNF inhibitor, binding TNF and blocking its inflammatory signaling. This mechanism underlies its study in immune-mediated conditions such as Behcet disease, psoriasis, and ulcerative colitis.
Infliximab is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is listed as the developer of the infliximab clinical programs described here.
Infliximab is in Phase 3 development. It remains an investigational agent in the programs described here, with Phase 3 trials completed in intestinal Behcet's disease, ulcerative colitis, and plaque-type psoriasis, and a Phase 2 trial recruiting in cytokine release syndrome prophylaxis.
Infliximab trials include NCT07657312, a recruiting Phase 2 study of cytokine release syndrome prophylaxis during teclistamab or talquetamab therapy in relapsed or refractory myeloma, plus completed Phase 3 trials NCT02505568 in intestinal Behcet's disease, NCT01551290 in ulcerative colitis, and NCT01177800 in plaque-type psoriasis.