Dexa-Myositis Trial: treatment of polymyositis and dermatomyositis - dexamethasone versus prednisone

ISRCTN	ISRCTN48188950
DOI	https://doi.org/10.1186/ISRCTN48188950
Protocol serial number	NTR169
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr J. van de Vlekkert
Scientific

Academical Medical Centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 9111
Email	j.vandevlekkert@amc.uva.nl

Primary study design	Interventional
Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Dexamethasone pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Myositis, dermatomyositis, polymyositis
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone, prednisone
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
Key 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
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Polymyositis 2. Dermatomyositis 3. Myositis with rheumatological disorders 4. Myositis with cancer 5. Unspecified myositis
Key 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
Date of first enrolment	01/07/2001
Date of final enrolment	01/01/2008

Academical Medical Centre

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan