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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Trial has reached 62% of planned recruitment (31 patients randomized).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    1Prednison   2Prednison MTX
STARTED   16   15 
COMPLETED   13   14 
NOT COMPLETED   3   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   1Prednison   2Prednison MTX   Total 
Overall Participants Analyzed 
[Units: Participants]
 16   15   31 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.6  (14.4)   53.5  (17.4)   52.6  (15.7) 
Gender 
[Units: Participants]
     
Female   10   10   20 
Male   6   5   11 
Region of Enrollment 
[Units: Participants]
     
Czech Republic   13   8   21 
Sweden   3   1   4 
Switzerland   0   4   4 
Hungary   0   1   1 
Poland   0   1   1 


  Outcome Measures

1.  Primary:   The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.   [ Time Frame: 1 year ]

2.  Secondary:   Assessment of Disease Activity and Damage,Muscle Strength and Endurance, Enzyme Levels, Glucocorticoid Side-effects, Dose, HAQ,SF-36, Treatment Failures   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   12/2016  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: vencovsky@revma.cz



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