Condition category
Musculoskeletal Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
16/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. van de Vlekkert

ORCID ID

Contact details

Academical Medical Centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 9111
j.vandevlekkert@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR169

Study information

Scientific title

Acronym

Study hypothesis

Dexamethasone pulse therapy is saver and as good as/or better than treatment with prednisone in patients with myositis.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, double blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Dexamethasone, prednisone

Primary outcome measures

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 trial start date

01/07/2001

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Polymyositis
2. Dermatomyositis
3. Myositis with rheumatological disorders
4. Myositis with cancer
5. Unspecified myositis

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

01/07/2001

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academical Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes