Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis

This study has been completed.

Sponsor:

Information provided by:

Mitsubishi Tanabe Pharma Corporation

ClinicalTrials.gov Identifier:

NCT00691028

First received: June 3, 2008

Last updated: NA

Last verified: June 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	June 3, 2008
Last Updated Date	June 3, 2008
Start Date ^ICMJE	September 2005
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 3, 2008)	ACR-N [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: June 3, 2008)	ACR20, 50, 70% improvement, Tender joint counts and Swollen joint count, CRP, DAS28, HAQ and modified Sharp score [ Time Frame: 54 weeks ] [ Designated as safety issue: No ] Safety: Adverse events, adverse drug reactions [ Time Frame: 54 weeks ] [ Designated as safety issue: Yes ] Pharmacokinetics- 1)Serum Concentration of Infliximab; and 2)Antibody to Infliximab（ATI) [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Official Title ^ICMJE	Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Brief Summary	The purpose of this study is to assess the efficacy, safety and pharmacokinetics of maintenance treatment with 3mg/kg, 6mg/kg or 10mg/kg of TA-650 (Infliximab) in combination with methotrexate (MTX) after three infusions (weeks-0, 2, 6) of 3mg/kg in Rheumatoid Arthritis (RA) showing an insufficient response to MTX.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: TA-650 3 mg/kg 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. Other Names: Infliximab REMICADE Drug: TA-650 6 mg/kg 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6 weeks. Then 6 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. Other Names: Infliximab REMICADE Drug: TA-650 10 mg/kg 3 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 0, 2 and 6. Then 10 mg/kg of TA-650 will be intravenously infused over a period of more than 2 hours at weeks 14, 22, 30, 38 and 46. Other Names: Infliximab REMICADE
Study Arm (s)	Experimental: 1 TA-650 3 mg/kg Intervention: Drug: TA-650 3 mg/kg Experimental: 2 TA-650 6 mg/kg Intervention: Drug: TA-650 6 mg/kg Experimental: 3 TA-650 10 mg/kg Intervention: Drug: TA-650 10 mg/kg
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	327
Completion Date	May 2007
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients with active Rheumatoid Arthritis in spite of stable dose of methotrexate Exclusion Criteria: Having received infliximab in the past Having a history of serious infection which caused hospitalization within 6 months before the registration Having an active tuberculosis Having a complication or a history of malignancy within 5 years before the registration
Gender	Both
Ages	20 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT Number ^ICMJE	NCT00691028
Other Study ID Numbers ^ICMJE	TA-650-13, JapicCTI-050146
Has Data Monitoring Committee	No
Responsible Party	General Manager, Clinical Research Department III, Mitsubishi Tanabe Pharma Corporation
Study Sponsor ^ICMJE	Mitsubishi Tanabe Pharma Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Mitsubishi Tanabe Pharma Corporation
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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