Idiopathic Inflammatory MyopathiesNCT03092180
Optimizing Treatment on Idiopathic Inflammatory Myopathies
An observational study of Idiopathic Inflammatory Myopathies, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset. This scheme is an internal routine protocol of our Service. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- What is being tested?
- Intravenous Infusion
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2005to 4 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic inflammatory myopathies
Who may be able to join
- Idiopathic inflammatory myopathies
Who cannot join
- Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Samuel Katsuyuki Shinjo
São Paulo, 01246903
About this study
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.
This scheme is an internal routine protocol of our Service.
Read the detailed description
To compare two groups of patients as described in Brief Summary.
- Conditions
- Idiopathic Inflammatory Myopathies
- Being tested
- Intravenous Infusion
- Keywords
- Dermatomyositis, Immunomodulation, Immunosuppressive agents, Myositis, Polymyositis, Necrotizing myopathies, Antisynthetase syndrome
- Medical subject headings
- Myositis, Dermatomyositis, Polymyositis, Antisynthetase syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous InfusionDrug
Also called Medicine
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic inflammatory myopathies 1 | Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset Receives: Drug: Intravenous Infusion | |
| Idiopathic inflammatory myopathies 2 | Intravenous infusion with methyprednisolone at disease onset Receives: Drug: Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Global Activity
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
Measured: Six months
Patient/Parent Global Activity -
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
Measured: Six months
Manual Muscle Testing
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
Measured: Six months
Health Assessment Questionnaire
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
Measured: Six months
Muscle Enzymes
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
Measured: Six months
Myositis Disease Activity Assessment Tool
After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)
Measured: Six months
Secondary outcomes (1)
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)
Effect of drugs in disease outcomes
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study startJan 2005
- Primary completion6 May 2024
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
- Investigators
- Samuel K Shinjo, PhD, Principal investigator, Universidade de Sao Paulo - Rheumatology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092180
- Sponsor's protocol ID
- MYO-HCFMUSP-01
- Status last verified
- Dec 2024
- First submitted
- 9 Mar 2017
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Treatment on Idiopathic Inflammatory Myopathies
- ClinicalTrials.gov ID
- NCT03092180
- Acronym / sponsor ID
- MYO-HCFMUSP-01
- Conditions
- Idiopathic Inflammatory Myopathies
- Keywords
- Dermatomyositis, Immunomodulation, Immunosuppressive agents, Myositis, Polymyositis, Necrotizing myopathies, Antisynthetase syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.
This scheme is an internal routine protocol of our Service.
Detailed description
To compare two groups of patients as described in Brief Summary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic inflammatory myopathies 1 | – | Drug: Intravenous InfusionIntravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset |
| Idiopathic inflammatory myopathies 2 | – | Drug: Intravenous InfusionIntravenous infusion with methyprednisolone at disease onset |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic inflammatory myopathies
Key inclusion criteria (1 listed)
- Idiopathic inflammatory myopathies
Key exclusion criteria (1 listed)
- Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous InfusionAlso: MedicineIntravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin | Drug | Idiopathic inflammatory myopathies 1, Idiopathic inflammatory myopathies 2 |
Primary outcome
Physician Global Activity
Time frame: Six months
This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
Patient/Parent Global Activity -
Time frame: Six months
This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
Manual Muscle Testing
Time frame: Six months
This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
Health Assessment Questionnaire
Time frame: Six months
Define the health assessement questionnaire. Pontuaction: 0.00-3.00
Muscle Enzymes
Time frame: Six months
This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase.
Myositis Disease Activity Assessment Tool
Time frame: Six months
After local anesthesia, a cutaneous incision will be made in lateral thigh face. The biopsy will be done using the Bergstrom needle. Histological (hematoxylin and eosin)/immunohistochemical (CD4, CD8, CD68, CD20, C5b-9, MHCI, MHCII, CD31) analysis will be performed in muscle samples (at baseline and after 12 weeks) in all patients (present study)
1 secondary outcome
Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel K Shinjo, PhD principal investigator
Universidade de Sao Paulo - Rheumatology Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Inflammatory Myopathies, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel K Shinjo, PhD (55-11-3061-7176, samuel.shinjo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician Global Activity (time frame: Six months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.