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An open-label, randomized controlled trial for baratinib in the treatment of dermatomyositis

An open-label, randomized controlled trial for baratinib in the treatment of dermatomyositis

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030591
Enrollment
Unknown
Registered
2020-03-08
Start date
2019-12-01
Completion date
Unknown
Last updated
2020-03-09

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

Conditions

dermatomyositis

Interventions

Control group:Placebo

Sponsors

Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. DM was diagnosed based on the criteria of Bohan and Peter12 and CADM diagnosis followed the modified Sontheimer definition; 2. Aged 18-75 years; 3. Participants or guardians are fully aware of the trial and are willing to participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. With other connective tissue diseases or recent infections or tumors; 2. Breastfeeding women and children during pregnancy; 3. Participating in any other drug investigator within three months prior to the start of the trial; 4. Frequent use of sleeping sedatives or other addictive drugs; 5. Patients with serious underlying diseases; Alcoholic psychopaths; 6. The subject is unable to complete the study or the investigator considers it inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
CDASI scoring;

Secondary

MeasureTime frame
Light measurement;VISIA analysis;Muscle scoring MMT8;inflammatory mediator;Evaluation of quality of life;

Countries

China

Contacts

Public ContactJie Zheng

Rui Jin Hospital, School of Medicine, Shanghai Jiao Tong University

jie-zheng2001@126.com+86 18917762311

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026