Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone

Completed

Conditions: Myositis, dermatomyositis, polymyositis
Musculoskeletal Diseases
Myositis

Registration Number: ISRCTN48188950

Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 80

Inclusion Criteria

1. Polymyositis
2. Dermatomyositis
3. Myositis with rheumatological disorders
4. Myositis with cancer
5. Unspecified myositis

Exclusion Criteria

1. Myositis in family
2. Greater than 3/1000 rimmed vacuoles
3. Quick (less than 2 weeks) rise and spontaneous normalisation (less than 2 months) of serum creatine kinase (CK) level
4. Aged less than 18 years
5. Contra-indication for one of the two treatments
6. Desire to get pregnant or active pregnancy
7. No informed consent
8. Greater than 20 mg prednisone/day

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Combined scale: Rankin, muscle strength, Visual Analogue Scale (VAS) pain, time until remission, no relapse, no cushing, no osteoporosis<br>2. Percentage patients in remission, time to remission, no relapse<br>3. General assessment of condition of patients

Secondary Outcome Measures

Name	Time	Method
1. Weight<br>2. Blood pressure<br>3. VAS arthralgia, Raynaud<br>4. Skin changes<br>5. CK<br>6. Myometry<br>7. VAS dysphagia<br>8. VAS agitation<br>9. Quality of life<br>10. Medication and dose<br>11. Other side effects<br>12. Neuromusclular symptom score