Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    cf101 rheumatoid arthritis

Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients

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: NCT00556894
Recruitment Status : Completed
First Posted : November 12, 2007
Results First Posted : March 9, 2015
Last Update Posted : March 29, 2018
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: Prevention
Condition Rheumatoid Arthritis
Interventions Drug: CF101
Drug: Placebo
Enrollment 253
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CF101 0.1mg CF101 1mg Placebo
Hide Arm/Group Description CF101 0.1mg orally q12 for 12 weeks CF101 1mg orally q12 for 12 weeks Matching placebo
Period Title: Overall Study
Started 82 87 84
Completed 66 68 65
Not Completed 16 19 19
Reason Not Completed
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
Arm/Group Title CF101 0.1mg CF101 1mg Placebo Total
Hide Arm/Group Description CF101: orally q12h CF101: orally q12h CF101: orally q12h Total of all reporting groups
Overall Number of Baseline Participants 82 87 84 253
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 87 participants 84 participants 253 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
66
  80.5%
69
  79.3%
69
  82.1%
204
  80.6%
>=65 years
16
  19.5%
18
  20.7%
15
  17.9%
49
  19.4%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 82 participants 87 participants 84 participants 253 participants
55
(24 to 75)
54
(25 to 75)
54
(33 to 73)
54
(24 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 82 participants 87 participants 84 participants 253 participants
Female
68
  82.9%
64
  73.6%
71
  84.5%
203
  80.2%
Male
14
  17.1%
23
  26.4%
13
  15.5%
50
  19.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 82 participants 87 participants 84 participants 253 participants
Serbia 22 20 20 62
Ukraine 22 26 26 74
Israel 9 9 8 26
Bulgaria 29 32 30 91
1.Primary Outcome
Title ACR20 at Week 12
Hide Description Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CF101 0.1mg CF101 1mg Placebo
Hide Arm/Group Description:
CF101 0.1mg orally q12
CF101 1mg orally q12
Placebo orally q12
Overall Number of Participants Analyzed 66 68 65
Measure Type: Number
Unit of Measure: participants
29 34 33
2.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 ACR20/50/70 responses over time (intent-to-treat [ITT], last observation carried forward [LOCF]), mean changes in individual components of the ACR response criteria, DAS28, European League Against Rheumatism (EULAR) responses
Time Frame 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CF101 0.1mg CF101 1mg Placebo
Hide Arm/Group Description CF101 0.1mg q12 for 12 weeks CF101 1mg q12 for 12 weeks Matching Placebo q12 for 12 weeks
All-Cause Mortality
CF101 0.1mg CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
CF101 0.1mg CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/82 (3.66%)   2/87 (2.30%)   3/84 (3.57%) 
Blood and lymphatic system disorders       
Pancytopenia [1]  1/82 (1.22%)  0/87 (0.00%)  0/84 (0.00%) 
Microcytic anemia [2]  0/82 (0.00%)  0/87 (0.00%)  1/84 (1.19%) 
Eye disorders       
Eyelid oedema [3]  0/82 (0.00%)  0/87 (0.00%)  1/84 (1.19%) 
Gastrointestinal disorders       
Nausea and Diarrhoea [4]  1/82 (1.22%)  2/87 (2.30%)  0/84 (0.00%) 
Investigations       
Alanine aminotransferase and Aspartate aminotransferase increased [5]  1/82 (1.22%)  1/87 (1.15%)  1/84 (1.19%) 
[1]
Pancytopenia
[2]
HYPOCHROMIC MICROCYTIC ANEMIA III ST.
[3]
OEDEMA OF BOTH EYELIDS WITH CARIAL RASH ON THE NECK
[4]
Nausea and Diarrhoea
[5]
Elevated ALAT and ASAT
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CF101 0.1mg CF101 1mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/82 (2.44%)   5/87 (5.75%)   1/84 (1.19%) 
Gastrointestinal disorders       
Nausea [1]  2/82 (2.44%)  5/87 (5.75%)  1/84 (1.19%) 
[1]
Nausea
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: NCT00556894    
Other Study ID Numbers: CF101-203RA
First Submitted: November 8, 2007
First Posted: November 12, 2007
Results First Submitted: February 24, 2015
Results First Posted: March 9, 2015
Last Update Posted: March 29, 2018