NCT00004357

Brief Summary

Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak muscles in children. The purpose of this study is to measure the absorption of oral prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease activity indicators in the blood. These levels will be compared to see if there are patterns specific to active and less active JDM.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

8.3 years

First QC Date

October 18, 1999

Last Update Submit

July 20, 2011

Conditions

Vasculitis, HypersensitivityConnective Tissue DiseasesDermatomyositisVasculitis

Keywords

Cardiovascular DiseaseRespiratory DiseaseRare DiseasesVasculitis

Interventions

MethylprednisoloneDRUG

IV

PrednisoloneDRUG

Oral

Eligibility Criteria

Age4 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Juvenile dermatomyositis with evidence of active vasculitis
  • Elevated von Willebrand factor antigen prior to study entry
  • Elevated neopterin level prior to study entry

You may not qualify if:

  • Severe renal involvement
  • Critically ill or clinically unstable
  • Diseases other than dermatomyositis with vasculitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Vasculitis, Leukocytoclastic, CutaneousConnective Tissue DiseasesDermatomyositisVasculitisCardiovascular DiseasesRespiration DisordersRare Diseases

Interventions

MethylprednisolonePrednisolone

Condition Hierarchy (Ancestors)

Vascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityImmune System DiseasesPolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Lauren M. Pachman, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

September 1, 1997

Primary Completion

December 1, 2005

Study Completion

February 1, 2008

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

US(1)