Dexamethason pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.
ID
Bron
Verkorte titel
Aandoening
polymyositis, dermatomyositis, myositis with rheumatological disorders, myositis with cancer, unspecified myositis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Combined scale:<br> Rankin, muscle strength, VAS pain, time untill remission, no relaps, no cushing, no osteoporosis;<br>
2. Percentage patients in remission, time to remission, no relapse;<br>
3. General assessment of condition of patients.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Dexamethason pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 22660
J. Vlekkert, van de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.vandevlekkert@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
J. Vlekkert, van de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.vandevlekkert@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Polymyositis;
2. Dermatomyositis;
3. Myositis with rheumatological disorders;
4. Myositis with cancer;
5. Unspecified myositis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL135 |
| NTR-old | NTR169 |
| Ander register | : N/A |
| ISRCTN | ISRCTN48188950 |