Trial Outcomes & Findings for Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate (NCT NCT00369928)
NCT ID: NCT00369928
Last Updated: 2011-09-08
Results Overview
percent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
254 participants
Primary outcome timeframe
12 weeks
Results posted on
2011-09-08
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo, oral dose, BID
|
25 mg PG-760564 BID
25 mg BID, of oral PG-760564
|
100 mg PG-760564 BID
100 mg BID, of oral PG-760564
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
86
|
|
Overall Study
COMPLETED
|
77
|
69
|
66
|
|
Overall Study
NOT COMPLETED
|
8
|
16
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of 2 Oral Doses of PG-760564 in Rheumatoid Arthritis (RA) Patients Receiving Methotrexate
Baseline characteristics by cohort
| Measure |
Placebo
n=85 Participants
Placebo, oral dose, BID
|
25 mg PG-760564 BID
n=85 Participants
25 mg BID, of oral PG-760564
|
100 mg PG-760564 BID
n=86 Participants
100 mg BID, of oral PG-760564
|
Total
n=256 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
|
75 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
232 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age Continuous
|
51.52 years
STANDARD_DEVIATION 11.04 • n=5 Participants
|
50.39 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
54.70 years
STANDARD_DEVIATION 9.31 • n=5 Participants
|
52.21 years
STANDARD_DEVIATION 10.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
45 participants
n=5 Participants
|
42 participants
n=7 Participants
|
49 participants
n=5 Participants
|
136 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
16 participants
n=5 Participants
|
57 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
12 participants
n=5 Participants
|
31 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weekspercent, relative to baseline, of patients meeting the American College of Rheumatology 20 response criteria (ACR20) at 12weeks
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo, oral dose, BID
|
25 mg PG-760564 BID
n=85 Participants
25 mg BID, of oral PG-760564
|
100 mg PG-760564 BID
n=86 Participants
100 mg BID, of oral PG-760564
|
|---|---|---|---|
|
Proportion of Patients Meeting American College of Rheumatology 20 Response Criteria (ACR20) at 12weeks
|
60 percent meeting ACR 20
Interval 48.0 to 72.0
|
56 percent meeting ACR 20
Interval 43.0 to 68.0
|
54 percent meeting ACR 20
Interval 41.0 to 67.0
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
25 mg PG-760564 BID
Serious events: 4 serious events
Other events: 2 other events
Deaths: 0 deaths
100 mg PG-760564 BID
Serious events: 6 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=85 participants at risk
Placebo, oral dose, BID
|
25 mg PG-760564 BID
n=85 participants at risk
25 mg BID, of oral PG-760564
|
100 mg PG-760564 BID
n=86 participants at risk
100 mg BID, of oral PG-760564
|
|---|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/85
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
General disorders
Pyrexia
|
0.00%
0/85
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.00%
0/85
|
1.2%
1/85 • Number of events 1
|
1.2%
1/86 • Number of events 1
|
|
Infections and infestations
Urosepsis
|
1.2%
1/85 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
|
Infections and infestations
Viral Infection
|
0.00%
0/85
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/85
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.00%
0/85
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/85
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/85
|
1.2%
1/85 • Number of events 1
|
0.00%
0/86
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/85
|
0.00%
0/85
|
1.2%
1/86 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
1.2%
1/85 • Number of events 1
|
0.00%
0/85
|
0.00%
0/86
|
Other adverse events
| Measure |
Placebo
n=85 participants at risk
Placebo, oral dose, BID
|
25 mg PG-760564 BID
n=85 participants at risk
25 mg BID, of oral PG-760564
|
100 mg PG-760564 BID
n=86 participants at risk
100 mg BID, of oral PG-760564
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
3.5%
3/85 • Number of events 4
|
2.4%
2/85 • Number of events 2
|
5.8%
5/86 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee It will be the Sponsor's responsibility to convene and charter a Publications Committee consisting of representation from the Sponsor and key academic and investigational centers. The Publications Committee will be primarily responsible for the creation, review, and submission of publications and presentations relating to the major aspects of the study (design, baseline data, mortality and safety data) and ancillary analyses after the completion of the study.
- Publication restrictions are in place
Restriction type: OTHER