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IRCT20210808052107N1 IRCT 2022-07-22 Shahid Beheshti University of Medical Sciences 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) 2022-04-30 anticipated 5 Complete https://irct.ir/trial/58329 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: In this study, Infliximab is used as an injection into a calcinosis lesion for the first time. 2 Juvenile Dermatomyositis (JDM). 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 at four points around the lesion. If the size of the lesion is 1.5-5 cm2, the amount of injectable drug will increase to 40 mg.. Yes - There is a plan to make this available What will be shared: The specific title of the file will be patients' information. In this file, patients' information including age, gender, time of diagnosis, clinical findings, data about the number, size, and consistency of calcinosis lesions in weekly examinations, and reported complications will be shared. When: The access period will start one month after publishing the results. To whom: Request for data will be possible for all researchers. Conditions: The only condition for using the data will be scientific fidelity and citation to the published study of the present study. Where to obtain: Applicants can send their request one month after the publication of the results. Email: Forough.e66@gmail.com How to obtain: The applicant should specify the Identification information, including name, surname, organizational affiliation, and the reason for requesting the data in his/her request. After reviewing the application, the requested data will be sent within a week. Comments:
public Forough Hosseini Moghadam Emami
Shariati Ave, Mofid children's hospital, Tehran, Iran
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2290 4603 forough.e66@gmail.com Shahid Beheshti University of Medical Sciences scientific Forough Hosseini Moghadam Emami
Shariati Ave, Mofid Children's hospital, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2290 4603 forough.e66@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of juvenile dermatomyositis Presence of calcinous lesions no limit 18 years Both Patients with Calcinosis lesion size greater than 5 cm2 Presence of calcinosis lesion in life threatening organs M33.0 Juvenile dermatomyositis Treatment - Drugs 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 at four points around the lesion. If the size of the lesion is 1.5-5 cm2, the amount of injectable drug will increase to 40 mg. 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. Shahid Beheshti University of Medical Sciences Approved 2022-04-26 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Street, Yaman Ave, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)