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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: January 30, 2014
Last verified: January 2014
Results First Received: January 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: TA-650 3 mg/kg
Drug: TA-650 6 mg/kg
Drug: TA-650 10 mg/kg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TA-650 3 mg/kg 99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
TA-650 6 mg/kg 104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
TA-650 10 mg/kg 104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
Open-label 327 patients received TA-650 at 3 mg/kg treatment during the open-label period.

Participant Flow for 2 periods

Period 1:   Open-label Period
    TA-650 3 mg/kg     TA-650 6 mg/kg     TA-650 10 mg/kg     Open-label  
STARTED     0     0     0     327  
COMPLETED     0     0     0     307  
NOT COMPLETED     0     0     0     20  
Adverse Event                 0                 0                 0                 16  
Withdrawal by Subject                 0                 0                 0                 3  
not come to a hospital                 0                 0                 0                 1  

Period 2:   Double-blind Period
    TA-650 3 mg/kg     TA-650 6 mg/kg     TA-650 10 mg/kg     Open-label  
STARTED     99     104     104     0  
COMPLETED     86     91     95     0  
NOT COMPLETED     13     13     9     0  
Adverse Event                 8                 9                 6                 0  
Lack of Efficacy                 4                 3                 2                 0  
Withdrawal by Subject                 1                 0                 1                 0  
not come to a hospital.                 0                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TA-650 3 mg/kg 99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
TA-650 6 mg/kg 104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
TA-650 10 mg/kg 104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
Total Total of all reporting groups

Baseline Measures
    TA-650 3 mg/kg     TA-650 6 mg/kg     TA-650 10 mg/kg     Total  
Number of Participants  
[units: participants]
  99     104     104     307  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     89     96     92     277  
>=65 years     10     8     12     30  
Age  
[units: years]
Mean ± Standard Deviation
  49.7  ± 11.7     48.8  ± 11.8     50.4  ± 12.5     49.6  ± 12.0  
Gender  
[units: participants]
       
Female     78     86     89     253  
Male     21     18     15     54  



  Outcome Measures
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1.  Primary:   Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)   [ Time Frame: baseline and week 54 ]

2.  Secondary:   Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)   [ Time Frame: 54 weeks ]

3.  Secondary:   Tender Joint Counts (TJC)   [ Time Frame: 54 weeks ]

4.  Secondary:   Swollen Joint Count (SJC)   [ Time Frame: 54 weeks ]

5.  Secondary:   CRP Level   [ Time Frame: 54 weeks ]

6.  Secondary:   Change From Baseline in DAS28   [ Time Frame: baseline and week 54 ]

7.  Secondary:   Change From Baseline to Week 54 in HAQ   [ Time Frame: 54 weeks ]

8.  Secondary:   Change in Modified Total Sharp Score (mTSS) at week54 From Baseline   [ Time Frame: baseline and week 54 ]

9.  Secondary:   Pharmacokinetics Positive- ATI   [ Time Frame: 54 weeks ]

10.  Secondary:   Pharmacokinetics- Serum Concentration of Infliximab   [ Time Frame: 54 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications:

Responsible Party: General Manager, Clinical Research Department III, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00691028     History of Changes
Other Study ID Numbers: TA-650-13, JapicCTI-050146
Study First Received: June 3, 2008
Results First Received: January 29, 2013
Last Updated: January 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare