Clinical trial NCT00805766: Efficacy and Safety of Increased Dose of TA-650 (Infliximab) in Patients With Crohn's Disease (CD)
Official title: Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Infliximab
REMICADE
Crohn's disease
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
timeFrame: Increased Dose Period (Week 0 to Week 8)
Secondary outcomes:
measure: CDAI at Each Evaluation Time Point in the Increased Dose Period
timeFrame: Increased Dose Period (every 4 weeks for up to 40 weeks)
measure: CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period
timeFrame: Increased Dose Period (every 4 weeks for up to 40 weeks)
measure: CDAI Change at Each Evaluation Time Point in the Increased Dose Period
timeFrame: Increased Dose Period (every 4 weeks for up to 40 weeks)
measure: Serum Concentration of TA-650 at Each Time Point
timeFrame: Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks
measure: Antibody to TA-650 Determination
timeFrame: Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40)
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: Investigational site
city: Kansai
country: Japan
facility: Investigational site
city: Kanto
country: Japan
facility: Investigational site
city: Kyushu
country: Japan
facility: Investigational site
Study officials:
affiliation: Department of Internal Medicine, Keio University School of Medicine
name: Toshifumi Hibi, Professor
role: STUDY_CHAIR
References: