Evaluation of the effect of Infliximab (a biological drug) on lesions caused by calcium deposition in patients with juvenile dermatomyositis

The effect of Infliximab injection into calcinosis lesions on patients with juvenile dermatomyositis (JDM)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210808052107N1

Enrollment

Registered

2022-07-22

Start date

2022-04-30

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Juvenile Dermatomyositis (JDM). Juvenile dermatomyositis

Interventions

Intervention group: Includes children with juvenile dermatomyositis who have at least two calcinous lesions. For every 1.5 cm2 of calcinosis lesion in the patient, 20 mg of Infliximab will be injected

Eligibility

Sex/Gender

All

Age

No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of juvenile dermatomyositis Presence of calcinous lesions

Exclusion criteria

Exclusion criteria: Patients with Calcinosis lesion size greater than 5 cm2 Presence of calcinosis lesion in life threatening organs

Design outcomes

Primary

Measure	Time frame
Number of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The number of lesions will be recorded.;Size of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The size of the lesions will be recorded in square centimeters.;Consistency of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The consistency of the lesions will be recorded as the physician estimates whether the lesion is softer or not.	—

Measure

Time frame

Number of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The number of lesions will be recorded.;Size of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The size of the lesions will be recorded in square centimeters.;Consistency of calcinosis lesions. Timepoint: At baseline and weekly for up to 10 weeks. Method of measurement: It will be determined weekly by a pediatric rheumatologist. The consistency of the lesions will be recorded as the physician estimates whether the lesion is softer or not.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactForough Hosseini Moghadam Emami

Shahid Beheshti University of Medical Sciences

forough.e66@gmail.com+98 21 2290 4603

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026