No registrations found.
ID
Source
Brief title
Health condition
Newly onset juvenile dermatomyositis patients.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to clinical remission.
Secondary outcome
1. Change over time in the clinical core set parameters (PRINTO core set for JDM);
2. Time to muscle enzyme normalisation;
3. Frequency of drop out due to ineffective treatment.
Background summary
N/A
Study objective
Combination therapy of steroids plus MTX induces remission faster and will therefor reduce steroid toxicity and disease damage.
Study design
N/A
Intervention
Randomisation into 3 groups:
1. Standard therapy steroids only;
2. Steroids plus methotrexate;
3. Steroids plus ciclosporin.
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
Inclusion criteria
1. Newly onset juvenile dermatomyositis;
2. Patients aged <18 years;
3. Negative pregnancy test;
4. Obtained informed consent;
5. Ability to comply.
Exclusion criteria
1. Neutropenia;
2. Failure to comply;
3. Ulcerations, cardio-pulmonary disease related to juv dermatomyositis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL609 |
| NTR-old | NTR667 |
| Other | : N/A |
| ISRCTN | Incomplete info for ISRCTN |