Trial Outcomes & Findings for Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients (NCT NCT00280917)

Results Overview

ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

254 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	CF101 0.1mg CF101 0.1 mg q12 hours orally	CF101 1mg CF101 1mg q12 hours orally	CF101 4mg CF101 4mg q12 hours orally	Placebo Matching placebo q12 hours orally
Overall Study STARTED	65	63	63	63
Overall Study COMPLETED	63	57	57	61
Overall Study NOT COMPLETED	2	6	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CF101 0.1mg CF101 0.1 mg q12 hours orally	CF101 1mg CF101 1mg q12 hours orally	CF101 4mg CF101 4mg q12 hours orally	Placebo Matching placebo q12 hours orally
Overall Study Adverse Event	1	1	4	1
Overall Study Change Therapy	1	2	0	0
Overall Study Withdrawal by Subject	0	2	0	1
Overall Study Noncompliance	0	1	2	0

Baseline Characteristics

Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CF101 0.1mg n=65 Participants CF101 0.1 mg q12 hours for 12 weeks	CF101 1mg n=63 Participants CF101 1 mg q12 hours for 12 weeks	CF101 4mg n=63 Participants CF101 4 mg q12 hours for 12 weeks	Placebo n=63 Participants Matching Placebo q12 hours for 12 weeks	Total n=254 Participants Total of all reporting groups
Age, Continuous	54.7 years STANDARD_DEVIATION 12.02 • n=5 Participants	54.3 years STANDARD_DEVIATION 9.98 • n=7 Participants	54.4 years STANDARD_DEVIATION 10.07 • n=5 Participants	53 years STANDARD_DEVIATION 10.86 • n=4 Participants	54.1 years STANDARD_DEVIATION 10.73 • n=21 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	46 Participants n=7 Participants	52 Participants n=5 Participants	52 Participants n=4 Participants	199 Participants n=21 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	55 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

ACR 20 response (20% improvnent in RA based on swollen and tender joint counts, physician and patient global assessments of disease activity, a patient pain score) at endpoint (Week 12), with all-cause dropouts considered as nonresponders (nonresponder imputation) in the Intent-To-Treat (ITT) population

Outcome measures

Outcome measures
Measure	CF101 0.1 mg n=63 Participants CF101 0.1 mg q12 hours for 12 weeks	CF101 1 mg n=57 Participants CF101 1 mg q12 hours for 12 weeks	CF101 4 mg n=57 Participants CF101 4 mg q12 hours for 12 weeks	Placebo n=61 Participants Matching placebo q12 hours for 12 weeks
ACR Efficacy Criteria	63 participants	57 participants	57 participants	61 participants

SECONDARY outcome

Timeframe: 12 weeks

ACR 20 response at all visits in the evaluable population and ACR 50 and ACR 70 responses at all visits in the ITT and evaluable populations using both nonresponder imputation and Last Observation Carried Forward (LOCF) analyses; change and percent change from baseline at each visit in the ITT and evaluable populations, analyzed using LOCF, in ACR response components \[tender joint count, swollen joint count, patient assessment of pain by VAS, patient global assessment of disease activity by VAS, physician global assessment of disease activity by VAS, HAQ DI, CRP (by central laboratory, using an standard-sensitivity assay capable of detecting changes below the upper limit of normal) and ESR\], Disease Activity Score (DAS28), and duration of morning stiffness.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Vital signs and weight, physical examinations, adverse event (AE) reporting, clinical laboratory testing, including liver function, renal function, complete blood count and clinical chemistries, urinalysis, and hematologic testing and 12-lead resting ECGs

Outcome measures

Outcome data not reported

Adverse Events

CF101 0.1mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

CF101 1mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

CF101 4mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CF101 0.1mg n=63 participants at risk CF101 0.1 mg given orally q12h for 12 weeks	CF101 1mg n=57 participants at risk CF101 1 mg given orally q12h for 12 weeks	CF101 4mg n=57 participants at risk CF101 4 mg given orally q12h for 12 weeks	Placebo n=61 participants at risk Matching placebo
Infections and infestations PNEUMONIA VIRALIS	0.00% 0/63	1.8% 1/57	0.00% 0/57	0.00% 0/61
Infections and infestations hepatitis acute	0.00% 0/63	0.00% 0/57	1.8% 1/57	0.00% 0/61
Respiratory, thoracic and mediastinal disorders COPD EXACERBATION	0.00% 0/63	1.8% 1/57	0.00% 0/57	0.00% 0/61
Eye disorders Visual Disturbance	1.6% 1/63	0.00% 0/57	0.00% 0/57	0.00% 0/61
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non small cell lung cancer	1.6% 1/63	0.00% 0/57	0.00% 0/57	0.00% 0/61
Infections and infestations Supposition of Chronic Bronchitis	0.00% 0/63	0.00% 0/57	1.8% 1/57	0.00% 0/61

Other adverse events

Adverse event data not reported

Additional Information

Pnina Fishman, PhD

Can-Fite Biopharma

Phone: 011972 39241114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place