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Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

This study has been completed.
Information provided by (Responsible Party):
Can-Fite BioPharma Identifier:
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
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
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  
Number of Participants  
[units: participants]
  82     87     84     253  
[units: participants]
<=18 years     0     0     0     0  
Between 18 and 65 years     66     69     69     204  
>=65 years     16     18     15     49  
[units: years]
Median (Full Range)
  (24 to 75)  
  (25 to 75)  
  (33 to 73)  
  (24 to 75)  
[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

Responsible Party: Can-Fite BioPharma 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