Trial Outcomes & Findings for Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis (NCT NCT00551707)
NCT ID: NCT00551707
Last Updated: 2014-04-29
Results Overview
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Day 98
Results posted on
2014-04-29
Participant Flow
Participant milestones
| Measure |
CRx-102 (2.7/180)
CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
|
CRx-102 (2.7/360)
Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole
|
Prednisolone
prednisolone
prednisolone: prednisolone (2.7 mg)
|
Dipyridamole
dipyridamole
dipyridamole: dipyridamole (360 mg)
|
Placebo
placebo
placebo: placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
22
|
13
|
8
|
4
|
|
Overall Study
COMPLETED
|
4
|
16
|
10
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
3
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
CRx-102 (2.7/180)
n=4 Participants
Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
|
CRx-102 (2.7/360)
n=22 Participants
Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole
|
Prednisolone
n=13 Participants
prednisolone
prednisolone: prednisolone (2.7 mg)
|
Dipyridamole
n=8 Participants
dipyridamole
dipyridamole: dipyridamole (180 mg or 360 mg)
|
Placebo
n=4 Participants
placebo
placebo: placebo
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 5.50 • n=93 Participants
|
56.2 years
STANDARD_DEVIATION 11.96 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 11.32 • n=27 Participants
|
56.5 years
STANDARD_DEVIATION 12.76 • n=483 Participants
|
58.8 years
STANDARD_DEVIATION 9.54 • n=36 Participants
|
56.0 years
STANDARD_DEVIATION 11.09 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
35 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
16 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 98Population: As treated population
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Outcome measures
| Measure |
CRx-102 (2.7/180)
n=4 Participants
CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
|
CRx-102 (2.7/360)
n=16 Participants
Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole
|
Prednisolone
n=10 Participants
prednisolone
prednisolone: prednisolone (2.7 mg)
|
Dipyridamole
n=4 Participants
dipyridamole
dipyridamole: dipyridamole (360 mg)
|
Placebo
n=3 Participants
placebo
placebo: placebo
|
|---|---|---|---|---|---|
|
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population
|
12.85 mg/L
Full Range 5.39 • Interval 6.6 to 18.9
|
14.25 mg/L
Full Range 15.52 • Interval 1.1 to 48.0
|
21.85 mg/L
Full Range 27.10 • Interval 1.2 to 80.2
|
16.60 mg/L
Full Range 16.22 • Interval 15.9 to 48.8
|
2.68 mg/L
Full Range 4.88 • Interval 0.9 to 10.1
|
SECONDARY outcome
Timeframe: baseline to day 98Population: As treated population
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Outcome measures
| Measure |
CRx-102 (2.7/180)
n=4 Participants
CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
|
CRx-102 (2.7/360)
n=16 Participants
Crx-102 (Dose 2)
2.7 mg prednisolone plus 360 mg dipyridamole
|
Prednisolone
n=10 Participants
prednisolone
prednisolone: prednisolone (2.7 mg)
|
Dipyridamole
n=4 Participants
dipyridamole
dipyridamole: dipyridamole (360 mg)
|
Placebo
n=3 Participants
placebo
placebo: placebo
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population
|
-29.90 percentage of change from baseline
Full Range 18.45 • Interval -36.1 to 3.8
|
-40.84 percentage of change from baseline
Full Range 66.80 • Interval -95.9 to 148.1
|
15.92 percentage of change from baseline
Full Range 1453.54 • Interval -80.6 to 4617.6
|
-33.67 percentage of change from baseline
Full Range 30.43 • Interval -54.4 to 15.0
|
-27.64 percentage of change from baseline
Interval -35.0 to 203.3
|
SECONDARY outcome
Timeframe: baseline to day 98Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 98 DaysPreliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Outcome measures
Outcome data not reported
Adverse Events
CRx-102 (Dose 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CRx-102 (Dose 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Prednisolone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dipyridamole
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CRx-102 (Dose 1)
n=4 participants at risk
Crx-102 (Dose 1)
CRx-102: prednisolone + dipyridamole
|
CRx-102 (Dose 2)
n=22 participants at risk
Crx-102 (Dose 2)
CRx-102: prednisolone + dipyridamole
|
Prednisolone
n=13 participants at risk
prednisolone
prednisolone: prednisolone (2.7 mg)
|
Dipyridamole
n=8 participants at risk
dipyridamole
dipyridamole: dipyridamole (180 mg or 360 mg)
|
Placebo
n=4 participants at risk
placebo
placebo: placebo
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
4.5%
1/22 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/13 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/8 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
25.0%
1/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
|
General disorders
Oedema Peripheral
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
9.1%
2/22 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/13 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/8 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
4.5%
1/22 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
7.7%
1/13 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/8 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
27.3%
6/22 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
7.7%
1/13 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
25.0%
2/8 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
50.0%
2/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/22 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
0.00%
0/13 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
25.0%
2/8 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
25.0%
1/4 • From subject entry into the study (defined as the time at which the informed consent form was signed) to the end of study visit at day 98
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60