Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00035958
• Date of registration: 07/05/2002
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Understanding the Pathogenesis and Treatment of Childhood Onset Dermatomyositis
• Scientific title: Toward Improved Understanding of Pathogenesis and Treatment of Childhood Onset Dermatomyositis
• Date of first enrolment: August 2002
• Target sample size: 75
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00035958
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Daniel J. Lovell, MD, MPH
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion criteria

Inclusion criteria at the time of enrollment:

- Definite or probable diagnosis of JDMS by the criteria of Bohan and Peter

- No prior systemic steroid treatment for JDMS

- If able to become pregnant (females) or impregnate (males) and are sexually active,
then must have negative serum pregnancy test at baseline and be utilizing effective
form of birth control

- Patient and/or parent or legal guardian must be willing to sign consent and assent
forms

Exclusion criteria at the time of enrollment:

- History of chronic or recurrent infections sufficient to preclude the use of
etanercept

- Prior treatment with specific TNF-blocking agents

- Demonstration of cutaneous or gastrointestinal (GI) ulceration at the time of
diagnosis

- JDMS-related pulmonary disease at time of diagnosis (interstitial lung disease or
aspiration pneumonia confirmed by radiograph)

- JDMS-related cardiomyopathy (echocardiogram confirmation)

- Any uncontrolled, clinically significant pre-existent systemic disease (hepatic,
renal, neurological, endocrine, cardiac, gastrointestinal, or hematologic disease)
within 24 weeks of start of study

- Known HIV, hepatitis B surface antigen not related to vaccination, or hepatitis C
antibody positivity

- Pregnant or nursing female

- Any of the following laboratory abnormalities at baseline: platelet count <
100,000/cmm, total white cell count of < 3000 cells/cmm, neutrophils < 1000
cells/cmm, serum bilirubin > 2 times upper limit of normal, estimated creatinine
clearance of < 90 mL/min/1.73 M2 BSA estimated by formula for males age 2 to <13
(0.55 X ht in cms/serum creatinine), age 13-18 (0.7 X ht in cms/serum creatinine) and
females age 2-18 (0.55 X ht in cms/serum creatinine)

- Received live virus vaccination within 3 months prior to study entry
(contraindication for MTX or etanercept therapy)

- Past or current substance abuse or psychiatric history that would interfere with
ability to give informed consent or comply with study requirements or physician
instructions



Age minimum: 4 Years
Age maximum: 16 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dermatomyositis

Intervention(s)

Drug: Methotrexate

Drug: Etanercept

Drug: Prednisone

Secondary ID(s)

P60AR047784

NIAMS-078

P60 AR47784

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Immunex Corporation

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)