Phase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.

Five year single blind, Phase III effectiveness randomised actively controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23726

Enrollment

160

Registered

2006-04-20

Start date

2006-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly onset juvenile dermatomyositis patients.

Interventions

Randomisation into 3 groups: 1. Standard therapy steroids only

2. Steroids plus methotrexate

3. Steroids plus ciclosporin.

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Neutropenia; 2. Failure to comply; 3. Ulcerations, cardio-pulmonary disease related to juv dermatomyositis.

Design outcomes

Primary

Measure	Time frame
Time to clinical remission.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactJ.T. Dissel, van

Leids Universitair Medisch Centrum Postbus 9600

j.t.van_dissel@lumc.nl+31715262613

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)