Trial Outcomes & Findings for Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM (NCT NCT00651040)
NCT ID: NCT00651040
Last Updated: 2016-05-12
Results Overview
The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
1 year
Results posted on
2016-05-12
Participant Flow
Trial has reached 62% of planned recruitment (31 patients randomized).
Participant milestones
| Measure |
1Prednison
Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
|
2Prednison MTX
MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
Baseline characteristics by cohort
| Measure |
1Prednison
n=16 Participants
Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
|
2Prednison MTX
n=15 Participants
MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 14.4 • n=93 Participants
|
53.5 years
STANDARD_DEVIATION 17.4 • n=4 Participants
|
52.6 years
STANDARD_DEVIATION 15.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
13 participants
n=93 Participants
|
8 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=93 Participants
|
1 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Switzerland
|
0 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.
Outcome measures
| Measure |
Prednison1
n=16 Participants
Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
|
Prednison Methotrexate 2
n=15 Participants
MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
|
|---|---|---|
|
The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
|
124 mg/kg
Standard Deviation 65.7
|
135 mg/kg
Standard Deviation 45.2
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
Adverse Events
1 Prednison
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
2 Prednison Methotrexate
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 Prednison
n=16 participants at risk
Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
|
2 Prednison Methotrexate
n=15 participants at risk
MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor
|
12.5%
2/16 • 1 year
|
20.0%
3/15 • 1 year
|
|
Musculoskeletal and connective tissue disorders
worsening of muscles
|
12.5%
2/16 • 1 year
|
0.00%
0/15 • 1 year
|
|
Skin and subcutaneous tissue disorders
worsening of skin
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • 1 year
|
|
General disorders
synkopa
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • 1 year
|
Other adverse events
| Measure |
1 Prednison
n=16 participants at risk
Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.
ARM 1 has only Prednisone
Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms
|
2 Prednison Methotrexate
n=15 participants at risk
MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.
|
|---|---|---|
|
Infections and infestations
infection
|
50.0%
8/16 • 1 year
|
40.0%
6/15 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
50.0%
8/16 • 1 year
|
20.0%
3/15 • 1 year
|
|
Cardiac disorders
cardiovascular
|
12.5%
2/16 • 1 year
|
13.3%
2/15 • 1 year
|
|
Gastrointestinal disorders
gastrointestinal
|
12.5%
2/16 • 1 year
|
20.0%
3/15 • 1 year
|
|
General disorders
general
|
18.8%
3/16 • 1 year
|
20.0%
3/15 • 1 year
|
|
Endocrine disorders
endocrine
|
12.5%
2/16 • 1 year
|
0.00%
0/15 • 1 year
|
|
Nervous system disorders
neurological
|
18.8%
3/16 • 1 year
|
0.00%
0/15 • 1 year
|
|
Psychiatric disorders
psychiatric
|
6.2%
1/16 • 1 year
|
0.00%
0/15 • 1 year
|
|
Reproductive system and breast disorders
gynecological
|
0.00%
0/16 • 1 year
|
6.7%
1/15 • 1 year
|
Additional Information
Rheumatology Institute Prague
Rheumatology Institute Prague
Phone: +420234075111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place