Study of Tofacitinib in Refractory Dermatomyositis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03002649
Phase
PHASE1
Status
Completed

Conditions

  • Dermatomyositis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Tofacitinib comes as an extended-release (XR) (long-acting) tablet to take by mouth. The extended-release tablet is usually taken with or without food once daily.

Study Details

The purpose of this study is to obtain preliminary data regarding the safety and efficacy of Janus kinase (JAK) inhibitor, tofacitinib, in adults with active, treatment-refractory dermatomyositis.

Key Dates

Start date
Jan 31, 2017
Status verified
Jun 2020
Primary completion
Sep 30, 2020
Completion
Sep 30, 2020

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tofacitinib
    All subjects will be provided Tofacitinib 11mg tablets for oral administration once daily. 12-week treatment period with optional 4-week treatment extension period.

Primary Outcome Measure

Number of participants who achieve International Myositis Assessment and Clinical Studies (IMACS) Definition of Improvement (DOI) [ Time Frame: Up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21224-

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Johns Hopkins University· Baltimore, MD

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