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Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM (Prometheus)

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ClinicalTrials.gov Identifier: NCT00651040
Recruitment Status : Completed
First Posted : April 2, 2008
Results First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Institute of Rheumatology, Prague

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Polymyositis
Dermatomyositis
Interventions Drug: Prednisone
Drug: Methotrexate
Enrollment 31

Recruitment Details Trial has reached 62% of planned recruitment (31 patients randomized).
Pre-assignment Details  
Arm/Group Title 1Prednison 2Prednison MTX
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 16 15
Completed 13 14
Not Completed 3 1
Arm/Group Title 1Prednison 2Prednison MTX Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 31 participants
51.6  (14.4) 53.5  (17.4) 52.6  (15.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
10
  62.5%
10
  66.7%
20
  64.5%
Male
6
  37.5%
5
  33.3%
11
  35.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Czech Republic 13 8 21
Sweden 3 1 4
Switzerland 0 4 4
Hungary 0 1 1
Poland 0 1 1
1.Primary Outcome
Title The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
Hide Description The primary endpoint which has benn measured was the total dose of glucocorticoids administered between baseline and the end of treatment.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prednison1 Prednison Methotrexate 2
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 16 15
Mean (Standard Deviation)
Unit of Measure: mg/kg
124  (65.7) 135  (45.2)
2.Secondary Outcome
Title Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures
Hide Description [Not Specified]
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Prednison 2 Prednison Methotrexate
Hide Arm/Group Description

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

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.

All-Cause Mortality
1 Prednison 2 Prednison Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 Prednison 2 Prednison Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   4/16 (25.00%)   5/15 (33.33%) 
General disorders     
synkopa   0/16 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
worsening of muscles   2/16 (12.50%)  0/15 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
tumor   2/16 (12.50%)  3/15 (20.00%) 
Skin and subcutaneous tissue disorders     
worsening of skin   0/16 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Prednison 2 Prednison Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   14/16 (87.50%)   11/15 (73.33%) 
Cardiac disorders     
cardiovascular   2/16 (12.50%)  2/15 (13.33%) 
Endocrine disorders     
endocrine   2/16 (12.50%)  0/15 (0.00%) 
Gastrointestinal disorders     
gastrointestinal   2/16 (12.50%)  3/15 (20.00%) 
General disorders     
general   3/16 (18.75%)  3/15 (20.00%) 
Infections and infestations     
infection   8/16 (50.00%)  6/15 (40.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal   8/16 (50.00%)  3/15 (20.00%) 
Nervous system disorders     
neurological   3/16 (18.75%)  0/15 (0.00%) 
Psychiatric disorders     
psychiatric   1/16 (6.25%)  0/15 (0.00%) 
Reproductive system and breast disorders     
gynecological   0/16 (0.00%)  1/15 (6.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Rheumatology Institute Prague
Organization: Rheumatology Institute Prague
Phone: +420234075111
Responsible Party: Institute of Rheumatology, Prague
ClinicalTrials.gov Identifier: NCT00651040     History of Changes
Other Study ID Numbers: 3401
First Submitted: March 31, 2008
First Posted: April 2, 2008
Results First Submitted: October 29, 2015
Results First Posted: May 12, 2016
Last Update Posted: May 12, 2016