CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Abataceptdrug
Likely dose
Abatacept 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02594735
NCT02594735Phase 4Completed

Abatacept for the Treatment of Refractory Juvenile Dermatomyositis

George Washington University·interventional·Posted Nov 3, 2015·Updated Aug 29, 2022

In Brief

A Phase 4 clinical trial evaluating Abatacept for Dermatomyositis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety and efficacy of subcutaneous abatacept in 10 patients seven years of age and older with refractory JDM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatomyositis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 3, 2015
Enrollment StartNov 1, 2015
Primary CompletionJul 16, 2021
Study CompletionOct 22, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.7 years ago

Interventions

Abataceptdrug

Study participation will consist of a screening visit and 5 protocol visits over six months (week 0, week 6, week 12, week 18, and week 24) for each subject, and phone follow-up (week 2, week 4, week 8, week 10, week 14, week 16, week 20, and week 22). At Visit 1, which will be treatment initiation, eligible subjects will be instructed on the use and side effects of subcutaneous abatacept and will be started on the study drug (abatacept 125 mg SQ weekly for subjects with body weight ≥ 50 KG or abatacept 87.5mg SQ for subjects with body weight \< 50 KG).