Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma
ClinicalTrials.gov Identifier:
NCT00556894
First received: November 8, 2007
Last updated: February 24, 2015
Last verified: August 2011
Results First Received: February 24, 2015  
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: Prevention
Condition: Rheumatoid Arthritis
Intervention: Drug: CF101

  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
CF101 0.1mg CF101 0.1mg orally q12 for 12 weeks
CF101 1mg CF101 1mg orally q12 for 12 weeks
Placebo Matching placebo

Participant Flow:   Overall Study
    CF101 0.1mg   CF101 1mg   Placebo
STARTED   82   87   84 
COMPLETED   66   68   65 
NOT COMPLETED   16   19   19 
Adverse Event                2                3                3 
Death                1                0                0 
regulatory decision in Bulgaria                10                14                13 
Change in therapy                2                1                2 
Withdrawal by Subject                1                1                1 



  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
CF101 0.1mg CF101: orally q12h
CF101 1mg CF101: orally q12h
Placebo CF101: orally q12h
Total Total of all reporting groups

Baseline Measures
   CF101 0.1mg   CF101 1mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   87   84   253 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   66   69   69   204 
>=65 years   16   18   15   49 
Age 
[Units: Years]
Median (Full Range)
 55 
 (24 to 75) 
 54 
 (25 to 75) 
 54 
 (33 to 73) 
 54 
 (24 to 75) 
Gender 
[Units: Participants]
       
Female   68   64   71   203 
Male   14   23   13   50 
Region of Enrollment 
[Units: Participants]
       
Serbia   22   20   20   62 
Ukraine   22   26   26   74 
Israel   9   9   8   26 
Bulgaria   29   32   30   91 


  Outcome Measures

1.  Primary:   ACR20   [ Time Frame: 12 weeks ]

2.  Secondary:   ACR 20/50/70, ITT and Evaluable Population, Last Observation Carried Disease Activity Score (DAS28) Change From Baseline at Each Visit in the Efficacy Parameters   [ Time Frame: 12 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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
phone: 011972 39241114
e-mail: pnina@canfite.co.il



Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT00556894     History of Changes
Other Study ID Numbers: CF101-203RA
Study First Received: November 8, 2007
Results First Received: February 24, 2015
Last Updated: February 24, 2015
Health Authority: United States: Food and Drug Administration