Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
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
Overall study end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Polymyositis
2. Dermatomyositis
3. Myositis with rheumatological disorders
4. Myositis with cancer
5. Unspecified myositis
Participant type(s)
Patient
Age group
Not Specified
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|