Trial Outcomes & Findings for Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients (NCT NCT00556894)
NCT ID: NCT00556894
Last Updated: 2018-03-29
Results Overview
Number of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
253 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-03-29
Participant Flow
Participant milestones
| Measure |
CF101 0.1mg
CF101 0.1mg orally q12 for 12 weeks
|
CF101 1mg
CF101 1mg orally q12 for 12 weeks
|
Placebo
Matching placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
82
|
87
|
84
|
|
Overall Study
COMPLETED
|
66
|
68
|
65
|
|
Overall Study
NOT COMPLETED
|
16
|
19
|
19
|
Reasons for withdrawal
| Measure |
CF101 0.1mg
CF101 0.1mg orally q12 for 12 weeks
|
CF101 1mg
CF101 1mg orally q12 for 12 weeks
|
Placebo
Matching placebo
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
3
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
regulatory decision in Bulgaria
|
10
|
14
|
13
|
|
Overall Study
Change in therapy
|
2
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
Baseline Characteristics
Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
CF101 0.1mg
n=82 Participants
CF101: orally q12h
|
CF101 1mg
n=87 Participants
CF101: orally q12h
|
Placebo
n=84 Participants
CF101: orally q12h
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
204 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Age, Continuous
|
55 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
54 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
203 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
62 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
22 participants
n=5 Participants
|
26 participants
n=7 Participants
|
26 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
8 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
30 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of patients that achieved 20% response at week 12 in American College of Rheumatology Criteria
Outcome measures
| Measure |
CF101 0.1mg
n=66 Participants
CF101 0.1mg orally q12
|
CF101 1mg
n=68 Participants
CF101 1mg orally q12
|
Placebo
n=65 Participants
Placebo orally q12
|
|---|---|---|---|
|
ACR20 at Week 12
|
29 participants
|
34 participants
|
33 participants
|
SECONDARY outcome
Timeframe: 12 weeksACR20/50/70 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
Outcome measures
Outcome data not reported
Adverse Events
CF101 0.1mg
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
CF101 1mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CF101 0.1mg
n=82 participants at risk
CF101 0.1mg q12 for 12 weeks
|
CF101 1mg
n=87 participants at risk
CF101 1mg q12 for 12 weeks
|
Placebo
n=84 participants at risk
Matching Placebo q12 for 12 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.2%
1/82
|
0.00%
0/87
|
0.00%
0/84
|
|
Blood and lymphatic system disorders
Microcytic anemia
|
0.00%
0/82
|
0.00%
0/87
|
1.2%
1/84
|
|
Investigations
Alanine aminotransferase and Aspartate aminotransferase increased
|
1.2%
1/82
|
1.1%
1/87
|
1.2%
1/84
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/82
|
0.00%
0/87
|
1.2%
1/84
|
|
Gastrointestinal disorders
Nausea and Diarrhoea
|
1.2%
1/82
|
2.3%
2/87
|
0.00%
0/84
|
Other adverse events
| Measure |
CF101 0.1mg
n=82 participants at risk
CF101 0.1mg q12 for 12 weeks
|
CF101 1mg
n=87 participants at risk
CF101 1mg q12 for 12 weeks
|
Placebo
n=84 participants at risk
Matching Placebo q12 for 12 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/82
|
5.7%
5/87
|
1.2%
1/84
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place