This study aimed to evaluate the effect of injection of Infliximab into calcinosis lesions caused by juvenile dermatomyositis.
Design
Non-randomized clinical trial, without control group, phase 2, 5 patients, single center
Settings and conduct
The children with juvenile dermatomyositis referred to the rheumatology clinic of Mofid children's hospital, were enrolled in this study. In the beginning, for every 1.5 cm of calcinosis lesion in the patient, 20 mg of Infliximab will be injected at four points around the lesion.
Participants/Inclusion and exclusion criteria
Patients with calcinosis lesions due to juvenile dermatomyositis (up to 18 years) will be included in the study. Patients with a calcinosis lesion larger than 5 cm2 will be excluded from the study.
Intervention groups
In the beginning, for every 1.5 cm of calcinosis lesion in the patient, 20 mg of Infliximab will be injected at four points around the lesion. If the lesion is 1.5 to 5 cm2, the drug will increase to 40 mg. Injections will be continued weekly for up to ten weeks. Radiographs of patients will be taken before the intervention and after the tenth injection in the tenth week. All patients will have an ultrasound in the fifth week. In addition, the size and number of calcinosis lesions, along with possible side effects reported by patients' parents, are collected weekly and recorded in patient-specific information forms.
Main outcome variables
Number of calcinosis lesions; size of calcinosis lesions; consistency of calcinosis lesions; probable complications of the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210808052107N1
Registration date:2022-07-22, 1401/04/31
Registration timing:registered_while_recruiting
Last update:2022-07-22, 1401/04/31
Update count:0
Registration date
2022-07-22, 1401/04/31
Registrant information
Name
Foroughossadat Hosseini Moghaddam emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
forough.e66@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-09-10, 1401/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Infliximab injection into calcinosis lesions on patients with juvenile dermatomyositis (JDM)
Public title
Evaluation of the effect of Infliximab (a biological drug) on lesions caused by calcium deposition in patients with juvenile dermatomyositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of juvenile dermatomyositis
Presence of calcinous lesions
Exclusion criteria:
Patients with Calcinosis lesion size greater than 5 cm2
Presence of calcinosis lesion in life threatening organs
Age
To 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, Infliximab is used as an injection into a calcinosis lesion for the first time.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi Street, Yaman Ave, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.SBMU.MSP.REC.1401.117
Health conditions studied
1
Description of health condition studied
Juvenile Dermatomyositis (JDM)
ICD-10 code
M33.0
ICD-10 code description
Juvenile dermatomyositis
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
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 data will become available and for how long
The access period will start one month after publishing the results.
To whom data/document is available
Request for data will be possible for all researchers.
Under which criteria data/document could be used
The only condition for using the data will be scientific fidelity and citation to the published study of the present study.
From where data/document is obtainable
Applicants can send their request one month after the publication of the results.
Email: Forough.e66@gmail.com
What processes are involved for a request to access data/document
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.