No registrations found.
ID
Source
Brief title
Health condition
polymyositis, dermatomyositis, myositis with rheumatological disorders, myositis with cancer, unspecified myositis
Sponsors and support
Intervention
Outcome measures
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;
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.
Background 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.
Study objective
Dexamethason pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.
Intervention
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.
P.O. Box 22660
J. Vlekkert, van de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.vandevlekkert@amc.uva.nl
P.O. Box 22660
J. Vlekkert, van de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
j.vandevlekkert@amc.uva.nl
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. 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL135 |
| NTR-old | NTR169 |
| Other | : N/A |
| ISRCTN | ISRCTN48188950 |