A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004410-13-CZ
• Date of registration: 25/10/2007
• Prospective Registration: Yes
• Primary sponsor: Institute od Rheumatology Prague
• Public title: A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS
• Scientific title: A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS
• Date of first enrolment: 12/03/2008
• Target sample size: 50
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004410-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Czech Republic, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria
1. Age between 18 - 80 years.
2. Patients with definite or probable polymyositis or dermatomyositis diagnosed according to diagnostic criteria (9, 10) (Appendix 1)
3. Physician’s own judgement of the disease activity that requires high dose immunosuppressive treatment (based on clinical assessment of weakness, elevation of muscle enzymes and, if available, on magnetic resonance imaging findings).
4. Previously untreated patients with the exception of glucocorticoid treatment up to 8 weeks
5. Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria
1. Treatment with any immunosuppressive drug prior the study start.
2. Treatment with glucocorticoids (> 20 mg of Prednisone or equivalent) more than 8 weeks prior to study start.
3. Drug induced myositis.
4. Polymyositis and dermatomyositis in association with other connective tissue disease.
5. Inclusion body myositis.
6. Patients with immunodeficiency syndrome.
7. Pregnancy and lactation.
8. Fertile women not using adequate contraception during the study, women planning to have children during the study course or 12 months after the end of the study.
9. Malignancy.
10. Juvenile dermatomyositis.
11. Uncontrolled, clinically significant hematological, cardiovascular, pulmonary, endocrine, metabolic, gastrointestinal, hepatic or renal disease, which according to physician’s consideration would interfere with high dose glucocorticoid and immunosuppressive treatment or would prevent to follow the treatment protocol.
12. Severe infection.
13. History of drug or alcohol abuse within the previous 6 months.
14. Patients known to be HIV positive.
15. Known hypersensitivity to methotrexate.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

active polymyositis, dermatomyositis
MedDRA version: 9.1 Level: LLT Classification code 10012503 Term: Dermatomyositis
MedDRA version: 9.1 Level: LLT Classification code 10036102 Term: Polymyositis

Intervention(s)

Trade Name: Methotrexat Lachema 2,5mg
Product Name: Methotrexat Lachema 2,5mg tbl.
Product Code: 44/154/85-C
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Current Sponsor code: 01
Other descriptive name: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2,5-

Trade Name: Prednison 5, 20 Léciva por. tablet nob.
Product Name: Prednison 5, 20 Léciva por. tablet nob.
Product Code: 56/104/75-C
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob
CAS Number: 53032
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Methotrexat Lachema 5 inj. sol
Product Name: Methotrexate Lachema 5inj. sol
Product Code: 44/196/81-C
Pharmaceutical Form: Solution for injection
INN or Proposed INN: methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Solu-medrol inj. PSO LQF 40mg
Product Name: Solu-medrol inj. PSO lqf 40mg
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: methylprednisoloni natrii succinas
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Secondary Objective: The secondary objectives are:

• Assessment of disease activity and damage [with the use of newly developed tools for myositis disease activity (MYOACT and MITAX) and myositis damage (MYODAM and MDI), as well as by global assessment of activity and damage by patients and by physician (1)].
•Muscle strength by manual muscle testing
•Muscle endurance
•Muscle enzyme levels
•Glucocorticoid related side-effects
•Final glucocorticoid dose
•Disability index by HAQ
•Quality of life by SF-36
•Number of patients with treatment failures


•Search for reliable prognostic parameters in the further prognosis of patients with inflammatory myopathies.

•Study of the pathogenic aspects of inflammatory myopathies. Therefore investigations of serum, lymphocytes, muscle tissue and MRI will be organized. DNA and RNA will be stored for future genetic studies.

Main Objective: The primary objective of the study is to determine the safety and efficacy of adding methotrexate (MTX) to glucocorticoids (GC) compared with glucocorticoid treatment alone in patients with inflammatory myopathies. The primary endpoint that will be measured is the total dose of glucocorticoids (in mg/kg weight) administered between baseline and the end of treatment.

Primary end point(s): The primary endpoint that will be measured is the total dose of glucocorticoids (in mg/kg weight) administered between baseline and the end of treatment.

Secondary ID(s)

3401