polymyositis, dermatomyositis, myositis with rheumatological disorders, myositis with cancer, unspecified myositis
Conditions
Interventions
Dexamethasone pulse therapy. 40 mg/dag every first four days of the month, for 6 months. Placebo on the other days of the months.
2. Prednisolone 1-1.5 mg/kg/day for 4 weeks, afther this slow reduct
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1. Polymyositis; 2. Dermatomyositis; 3. Myositis with rheumatological disorders; 4. Myositis with cancer; 5. Unspecified myositis.
Exclusion criteria
Exclusion criteria: 1. Myositis in family; 2. 3/1000 rimmed vacuoles; 3. Quick (<2 weeks) rise and spontaneous normalisation (<2 months) of serum CK level; 4. Age < 18 years; 5. Contra-indication for one of the two treatments; 6. Desire to get pregnant or active pregnancy; 7. No Informed Consent; 8. 20 mg prednisone/day.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Combined scale: Rankin, muscle strength, VAS pain, time untill remission, no relaps, no cushing, no osteoporosis; 2. Percentage patients in remission, time to remission, no relapse; 3. General assessment of condition of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight; 2. Bloodpressure; 3. VAS arthralgia, Raynaud; 4. Skin changes; 5. CK; 6. Myometry; 7. VAS dysfagia; 8. VAS agitation; 9. Quality of life; 10. Medication and dose; 11. Other side effects; 12. Neuromusclular symptom score. | — |
Contacts
Public ContactJ. Vlekkert, van de
Academical Medical Center (AMC), H2-221, P.O. Box 22660
Outcome results
None listed