Trial Outcomes & Findings for PET/CT Imaging Companion Study To ACTG A5314 (NCT NCT02312219)
NCT ID: NCT02312219
Last Updated: 2019-02-06
Results Overview
Arterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time. The most diseased segment is the approx 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the median value, of the TBR, from baseline to week 24
Recruitment status
COMPLETED
Target enrollment
35 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2019-02-06
Participant Flow
Participant milestones
| Measure |
Low Dose Methotrexate
Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.
Folic Acid: 1 mg folic acid once daily
Low Dose Methotrexate: An anti-inflammatory drug
|
Placebo
Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.
Folic Acid: 1 mg folic acid once daily
Placebo: placebo once weekly
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
22
|
|
Overall Study
COMPLETED
|
12
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
Reasons for withdrawal
| Measure |
Low Dose Methotrexate
Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.
Folic Acid: 1 mg folic acid once daily
Low Dose Methotrexate: An anti-inflammatory drug
|
Placebo
Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.
Folic Acid: 1 mg folic acid once daily
Placebo: placebo once weekly
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
could not schedule imaging in time
|
0
|
2
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Not randomized. Ineligible
|
0
|
1
|
Baseline Characteristics
PET/CT Imaging Companion Study To ACTG A5314
Baseline characteristics by cohort
| Measure |
Low Dose Methotrexate
n=12 Participants
Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.
Folic Acid: 1 mg folic acid once daily
Low Dose Methotrexate: An anti-inflammatory drug
|
Placebo
n=16 Participants
Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.
Folic Acid: 1 mg folic acid once daily
Placebo: placebo once weekly
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
n=5 Participants
|
55.5 years
n=7 Participants
|
54.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksArterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time. The most diseased segment is the approx 1-cm section of the vessel with the highest activity at baseline. The results are expressed as the change in the median value, of the TBR, from baseline to week 24
Outcome measures
| Measure |
Low Dose Methotrexate
n=12 Participants
Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.
Folic Acid: 1 mg folic acid once daily
Low Dose Methotrexate: An anti-inflammatory drug
|
Placebo
n=16 Participants
Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.
Folic Acid: 1 mg folic acid once daily
Placebo: placebo once weekly
|
|---|---|---|
|
Change in Arterial FDG Uptake (From Baseline) in the Most Diseased Segment
|
-0.126 TBR
Interval -0.41 to 0.258
|
0.026 TBR
Interval -0.176 to 0.438
|
SECONDARY outcome
Timeframe: baseline and 24 weeksArterial FDG Uptake provides a measure of inflammation in the artery wall. TBR is target-to-background ratio (a measure of the ratio of the activity in the vessel wall divided by the blood background). A negative number for the change in TBR implies a reduction in activity over time. The entire ascending aorta is used for this analysis. The results are expressed as the change in the median value, of the TBR, from baseline to week 24
Outcome measures
| Measure |
Low Dose Methotrexate
n=12 Participants
Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.
Folic Acid: 1 mg folic acid once daily
Low Dose Methotrexate: An anti-inflammatory drug
|
Placebo
n=16 Participants
Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.
Folic Acid: 1 mg folic acid once daily
Placebo: placebo once weekly
|
|---|---|---|
|
Change in Arterial FDG Uptake (From Baseline) in the Aorta
|
-0.064 TBR
Interval -0.327 to 0.113
|
0.063 TBR
Interval -0.13 to 0.425
|
Adverse Events
Low Dose Methotrexate
Serious events: 0 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
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place