Tofacitinib in skin calcifications in childhood myositis

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: M330- Juvenile dermatomyositis

• Registration Number: CTRI/2024/02/062740
• Lead Sponsor: Department of Pediatrics, AIIMS, New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Children age 2 to 18 years with

-Juvenile Dermatomyositis (JDM) OR Juvenile Dermatomyositis Systemic Scleroderma overlap (JDM-SSc) AND

-calcinosis cutis on physical examination or previous imaging.

Exclusion Criteria

1Patient cyclophosphamide during the preceding 1 month or rituximab in the last 6 months OR

-Topical tacrolimus OR

- Active Tuberculosis OR

- Hemoglobin (Hb) levels less than 9 g per dL OR

- Absolute lymphocyte count less than 500 cells per mm3

-Absolute neutrophil count less than 1000 cells per mm3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Tofacitinib on calcinosis cutis in children with JDM as assesed by reduction in Agatston score using ultra low-dose whole body CT scan.Timepoint: At baseline and 24 ±2 week follow-up

Secondary Outcome Measures

Name	Time	Method
1)Proportion of children demonstrating improvement in clinical scores ( CDASI and CMAS) <br/ ><br>2)Number of subjects with adverse events. <br/ ><br>3)Change in doses(mean) of steroids <br/ ><br>4)Correlation of baseline laboratory parameters ( myositis specific antibody and interferon levels) with outcome.Timepoint: 1) At baseline and 24 ±2 week follow-up <br/ ><br>2)Anytime from initiation of therapy to 24 ±2 weeks after initiation of therapy. <br/ ><br>3)Anytime from initiation of therapy to 24 ±2 weeks after initiation of therapy. <br/ ><br>4)At baseline and 24 ±2 week follow-up <br/ ><br>