Phase 3
Completed N=45
Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Source: ClinicalTrials.gov NCT00805766 ↗Enrolled (actual)
45
Serious AEs
14.7%
Results posted
Dec 2012
Primary outcomePrimary: Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period — 95.0 units on a scale
Summary
The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period |
95.0 | — |
| SECONDARY CDAI at Each Evaluation Time Point in the Increased Dose Period |
296.5; 119.0; 194.0; 126.0; 182.0; 121.0 | — |
| SECONDARY CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period |
59.5; 39.4; 70.0; 31.0; 58.6; 28.6 | — |
| SECONDARY CDAI Change at Each Evaluation Time Point in the Increased Dose Period |
163.0; 95.0; 161.0; 95.0; 164.0; 100.0 | — |
| SECONDARY Serum Concentration of TA-650 at Each Time Point |
1.12; 97.74; 4.93; 0.30; 5.25; 0.79 | — |
| SECONDARY Antibody to TA-650 Determination |
23.1; 17.9; 5.1; 5.1; 71.8; 76.9 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Crohn's disease
- Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician
Exclusion Criteria
- Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
- The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
- A history of a serious infusion reaction to REMICADE
- Pregnant, lactating, and probably pregnant women
- Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
- Patients judged to be inadequate to participate in this study by their physician
Data sourced from ClinicalTrials.gov (NCT00805766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.