|- candidate number||1285|
|- NTR Number||NTR169|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||30-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Dexa-Myositis Trial.|
|- Scientific Title||Dexa-Myositis Trial. Treatment of Polymyositis and Dermatomyositis: dexamethason versus prednisone.|
|- hypothesis||Dexamethason pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis. |
|- Healt Condition(s) or Problem(s) studied||Myositis, Polymyositis, Dermatomyositis|
|- Inclusion criteria||1. Polymyositis;|
3. Myositis with rheumatological disorders;
4. Myositis with cancer;
5. Unspecified myositis.
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-jul-2001|
|- planned closingdate||1-jan-2008|
|- Target number of participants||80|
|- 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 reduction in dose.
Both groups treatment agains osteoporosis with calci chew and fosamax.
|- Primary outcome||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 outcome||1. Weight;|
3. VAS arthralgia, Raynaud;
4. Skin changes;
7. VAS dysfagia;
8. VAS agitation;
9. Quality of life;
10. Medication and dose;
11. Other side effects;
12. Neuromusclular symptom score.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. J. Vlekkert, van de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. J. Vlekkert, van de|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Prinses Beatrix Fonds|
|- Brief summary||Is the treatment with dexamethasone pulse therapy saver and as good as or better than the treatment with prednisone in patients with polymyositis, dermatomyositis, myositis with rheumatological disease, myositis with cancer or unspecifiek myositis.
80 patients will participate in the multicentre randomized controlled trial. |
|- Main changes (audit trail)|
|- RECORD||23-aug-2005 - 15-dec-2006|