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Trial record 4 of 4 for:    cf101 rheumatoid arthritis

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01034306
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Sponsor:
Information provided by (Responsible Party):
Can-Fite BioPharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: CF101
Drug: Placebo control
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CF101 1mg Placebo
Hide Arm/Group Description CF101 1mg q12 for 12 weeks Matching placebo q12 for 12 weeks
Period Title: Overall Study
Started 42 37
Completed 37 34
Not Completed 5 3
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             2             2
hospitalized and decided to stop             1             0
Noncomplience             1             0
Arm/Group Title CF101 1mg Placebo Total
Hide Arm/Group Description CF101 1mg q12 for 12 weeks MAtching placebo q12 for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 42 37 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 37 participants 79 participants
56.7  (9.87) 61.7  (6.89) 59  (8.92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 37 participants 79 participants
Female
32
  76.2%
32
  86.5%
64
  81.0%
Male
10
  23.8%
5
  13.5%
15
  19.0%
1.Primary Outcome
Title American College of Rheumatology (ACR20)
Hide Description Primary efficacy was assessed using ACR20 response at Week 12, with all-cause dropouts considered as non-responders, in the ITT population.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF101 1mg Placebo
Hide Arm/Group Description:
CF101 1mg q12 for 12 weeks
Matching placebo q12 for 12 weeks
Overall Number of Participants Analyzed 42 37
Measure Type: Number
Unit of Measure: participants
42 37
2.Secondary Outcome
Title Safety: Adverse Event Reporting, Physical Examination, Vital Signs, Clinical Laboratory Testing
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CF101 1mg Placebo
Hide Arm/Group Description CF101 1mg q12 for 12 weeks Matching placebo q12 for 12 weeks
All-Cause Mortality
CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/42 (2.38%)   1/37 (2.70%) 
Cardiac disorders     
atrial fibrillation with uncontrolled ventricular response [1]  0/42 (0.00%)  1/37 (2.70%) 
Infections and infestations     
Pyoderma [2]  1/42 (2.38%)  0/37 (0.00%) 
[1]
atrial fibrillation with uncontrolled ventricular response
[2]
Pyoderma
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/37 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Pnina Fishman, PhD
Organization: Can-Fite Biopharma
Phone: 011972 39241114
EMail: pnina@canfite.co.il
Layout table for additonal information
Responsible Party: Can-Fite BioPharma
ClinicalTrials.gov Identifier: NCT01034306    
Other Study ID Numbers: CF101-204RA
First Submitted: December 16, 2009
First Posted: December 17, 2009
Results First Submitted: February 24, 2015
Results First Posted: March 9, 2015
Last Update Posted: March 9, 2015