Trial Outcomes & Findings for Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis (NCT NCT01034306)

NCT ID: NCT01034306

Last Updated: 2022-05-24

Results Overview

ACR20 Response is defined as a 20% improvement from baseline in disease: 1. \>20% improvement in tender joint count (TJC), and 2. \>20% improvement in swollen joint count (SJC), and 3. \>20% improvement in at least 3 of following 5: 1. Physician global assessment (PGA), 2. Patient global assessment (PAGA), 3. Patient pain assessment (PPA), 4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and 5. Most improved response of ESR and CRP

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 79 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2022-05-24

Participant Flow

Participant milestones

Measure	CF101 1mg CF101 1mg q12 for 12 weeks	Placebo Matching placebo q12 for 12 weeks
Overall Study STARTED	42	37
Overall Study COMPLETED	37	34
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Measure	CF101 1mg CF101 1mg q12 for 12 weeks	Placebo Matching placebo q12 for 12 weeks
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	2
Overall Study hospitalized and decided to stop	1	0
Overall Study Noncomplience	1	0

Baseline Characteristics

Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	CF101 1mg n=42 Participants CF101 1mg q12 for 12 weeks	Placebo n=37 Participants MAtching placebo q12 for 12 weeks	Total n=79 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 9.87 • n=5 Participants	61.7 years STANDARD_DEVIATION 6.89 • n=7 Participants	59 years STANDARD_DEVIATION 8.92 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT population, all-cause dropouts considered non-responders

ACR20 Response is defined as a 20% improvement from baseline in disease:

1. >20% improvement in tender joint count (TJC), and

2. >20% improvement in swollen joint count (SJC), and

3. >20% improvement in at least 3 of following 5:

1. Physician global assessment (PGA),

2. Patient global assessment (PAGA),

3. Patient pain assessment (PPA),

4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and

5. Most improved response of ESR and CRP

Outcome measures

Measure	CF101 1mg n=42 Participants CF101 1mg q12 for 12 weeks	Placebo n=37 Participants Matching placebo q12 for 12 weeks
Number of Subjects Achieving an American College of Rheumatology 20 (ACR20) Response (20% Improvement)	18 Participants	8 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT population, all-cause dropouts considered non-responders

ACR50 Response is defined as a 50% improvement from baseline in disease:

1. >50% improvement in TJC, and

2. >50% improvement in SJC, and

3. >50% improvement in at least 3 of following 5:

1. Physician global assessment (PGA),

2. Patient global assessment (PAGA),

3. Patient pain assessment (PPA),

4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and

5. Most improved response of ESR and CRP

Outcome measures

Measure	CF101 1mg n=37 Participants CF101 1mg q12 for 12 weeks	Placebo n=32 Participants Matching placebo q12 for 12 weeks
Number of Subjects Achieving an ACR50 Response (50% Improvement)	7 Participants	3 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT population, all-cause dropouts considered non-responders

ACR70 Response is defined as a 70% improvement from baseline in disease:

1. >70% improvement in TJC, and

2. >70% improvement in SJC, and

3. >70% improvement in at least 3 of following 5:

1. Physician global assessment (PGA),

2. Patient global assessment (PAGA),

3. Patient pain assessment (PPA),

4. Patient's assessment of physical function using Health Assessment Questionnaire (HAQ), and

5. Most improved response of ESR and CRP

Outcome measures

Measure	CF101 1mg n=37 Participants CF101 1mg q12 for 12 weeks	Placebo n=32 Participants Matching placebo q12 for 12 weeks
Number of Subjects Achieving an ACR70 Response (70% Improvement)	4 Participants	1 Participants

Adverse Events

CF101 1mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	CF101 1mg n=42 participants at risk CF101 1mg q12 for 12 weeks	Placebo n=37 participants at risk Matching placebo q12 for 12 weeks
Infections and infestations Pyoderma	2.4% 1/42	0.00% 0/37
Cardiac disorders atrial fibrillation with uncontrolled ventricular response	0.00% 0/42	2.7% 1/37

Other adverse events

Adverse event data not reported

Additional Information

Pnina Fishman, PhD

Can-Fite Biopharma

Phone: 011972 39241114

Email: pnina@canfite.co.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place