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Dexa-Myositis Trial.


- candidate number1285
- NTR NumberNTR169
- ISRCTNISRCTN48188950
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR30-aug-2005
- Secondary IDsN/A 
- Public TitleDexa-Myositis Trial.
- Scientific TitleDexa-Myositis Trial. Treatment of Polymyositis and Dermatomyositis: dexamethason versus prednisone.
- ACRONYMN/A
- hypothesisDexamethason pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.
- Healt Condition(s) or Problem(s) studiedMyositis, Polymyositis, Dermatomyositis
- Inclusion criteria1. Polymyositis;
2. Dermatomyositis;
3. Myositis with rheumatological disorders;
4. Myositis with cancer;
5. Unspecified myositis.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jul-2001
- planned closingdate1-jan-2008
- Target number of participants80
- InterventionsDexamethasone 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 outcome1. 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 outcome1. 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.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J. Vlekkert, van de
- CONTACT for SCIENTIFIC QUERIESDrs. J. Vlekkert, van de
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Prinses Beatrix Fonds
- PublicationsN/A
- Brief summaryIs 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)
- RECORD23-aug-2005 - 15-dec-2006


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