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

ISRCTN	ISRCTN48188950
DOI	https://doi.org/10.1186/ISRCTN48188950
Secondary identifying numbers	NTR169

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 16/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

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

Contact information

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

Study information

Study design	Multicentre, randomised, double blinded, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethasone, prednisone
Primary outcome measure	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 measures	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
Overall study start date	01/07/2001
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

Netherlands

Study participating centre

Academical Medical Centre

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Charity

Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan