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| Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone |
| Source of record | ISRCTN Register |
| ISRCTN | ISRCTN48188950 |
| Date applied | 20/12/2005 |
| Date ISRCTN assigned | 20/12/2005 |
| Local reference number(s) | NTR169 |
| Public title | Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Myositis, dermatomyositis, polymyositis |
| Study hypothesis | Dexamethasone pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis. |
| Design/methodology | Multicentre, randomised, double blinded, active controlled, parallel group trial |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Countries of recruitment | Netherlands |
| Participants - inclusion criteria | 1. Polymyositis 2. Dermatomyositis 3. Myositis with rheumatological disorders 4. Myositis with cancer 5. Unspecified myositis |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/07/2001 |
| Anticipated end date | 01/01/2008 |
| Status of trial | Completed |
| Target number of participants | 80 |
| Interventions | 1. 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, after this slow reduction in dose Both groups treatment against osteoporosis with calci-chew and Fosamax. |
| Primary outcome measure(s) | 1. Combined scale: Rankin, muscle strength, Visual Analogue Scale (VAS) pain, time until remission, no relapse, no cushing, no osteoporosis 2. Percentage patients in remission, time to remission, no relapse 3. General assessment of condition of patients |
| Secondary outcome measure(s) | 1. Weight 2. Blood pressure 3. VAS arthralgia, Raynaud 4. Skin changes 5. CK 6. Myometry 7. VAS dysphagia 8. VAS agitation 9. Quality of life 10. Medication and dose 11. Other side effects 12. Neuromusclular symptom score |
| Sources of funding | Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands) |
| Sponsor name | Academic Medical Centre (AMC) (Netherlands) |
| Sponsor details | Meibergdreef 9 Amsterdam Netherlands 1105 AZ |
| Sponsor website | http://www.amc.uva.nl/ |
| Contact name | Dr J. van de Vlekkert |
| Contact details | Academical Medical Centre Meibergdreef 9 Amsterdam Netherlands 1105 AZ |
| Contact telephone | +31 (0)20 566 9111 |
| Contact email | j.vandevlekkert@amc.uva.nl |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN48188950 |
| Date last extracted from ISRCTN register | 03/07/2009 |
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