|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00651040 |
|
Date of registration:
|
31/03/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
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. |
|
Date of first enrolment:
|
May 2008 |
|
Target sample size:
|
31 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00651040 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Czech Republic
| | | | | | | |
|
Contacts
|
|
Name:
|
Jiri Vencovsky, prof. MD. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institute of Rheumatology, Prague |
| | |
|
Key inclusion & exclusion 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 judgment 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.
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:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Dermatomyositis
|
|
Polymyositis
|
|
Intervention(s)
|
|
Drug: Methotrexate
|
|
Drug: Prednisone
|
|
Primary Outcome(s)
|
|
The Primary Endpoint is the Total Dose of Glucocorticoids Administered Between Baseline and the End of Treatment.
[Time Frame: 1 year]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|