Treatment Side EffectsNCT03092154
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
A study testing Lipid-lowering agents (Artovastatin) in people with Treatment Side Effects, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Side Effects
- What is being tested?
- Lipid-lowering agents (Artovastatin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- fullfill all criteria of Bohan and Peter (1975)
- dyslipidemia
- age> 18 years
- prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
- without changing nutritional habits in the last three months, and during the study period
- no change of lifestyle in the last three months, and during the study period
Who cannot join
- Patients with:
- disease relapsing
- overlapping myositis
- neoplasia associated myositis
- diabetes mellitus
- current and/or chronic infections
Show all 11Show fewer
- patients undergoing major surgery within six months prior to the study
- pregnant patients
- previous use of lipid-lowering agents in the last 6 months
- in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem
- active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality
Trial locations and contacts
1 site in 1 country.
About this study
The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.
Read the detailed description
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
- Conditions
- Treatment Side Effects
- Being tested
- Lipid-lowering agents (Artovastatin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid-lowering agents (Artovastatin)Drug
Also called Therapy
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Experimental | Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks Receives: Drug: Lipid-lowering agents (Artovastatin) |
| No intervention | No intervention | Patients will not receive artovastatin (lipid-lowering agents) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Ultrasound-based measurements of brachial reactivity were performed according to the guidelines of the International Brachial Artery Reactivity Task Force. The assessment of vascular reactivity was carried out by the same examiner. The left brachial artery was measured at a longitudinal section above the antecubital fossa, using a high-resolution ultrasound system Sequoia Echocardiography System, version 6.0, Acuson; Siemens, Vernon, CA) equipped with a multifrequency linear transducer (7-12 MHz) to produce two-dimensional images. This technique was used to evaluate the change in arterial diameter and blood flow after physical and pharmacological stimulation.
Measured: 12 weeks
Secondary outcomes (7)
Side effects
Side effects of lipid-lowering agents
Measured: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
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: 12 weeks
Health Assessment Questionnaire
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Measured: 12 weeks
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 2017
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Side EffectsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: with or without lipid-lowering agents
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
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
- NCT03092154
- Sponsor's protocol ID
- MYO-HCFMUSP-03
- Status last verified
- May 2022
- First submitted
- 9 Mar 2017
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
- ClinicalTrials.gov ID
- NCT03092154
- Acronym / sponsor ID
- MYO-HCFMUSP-03
- Conditions
- Treatment Side Effects
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- 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.
The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.
Detailed description
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups: with or without lipid-lowering agents
| Arm | Type | Receives |
|---|---|---|
| Exposed | Experimental | Drug: Lipid-lowering agents (Artovastatin)Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks |
| No intervention | No intervention | –Patients will not receive artovastatin (lipid-lowering agents) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- fullfill all criteria of Bohan and Peter (1975)
- dyslipidemia
- age> 18 years
- prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
- without changing nutritional habits in the last three months, and during the study period
Key exclusion criteria (11 listed)
- disease relapsing
- overlapping myositis
- neoplasia associated myositis
- diabetes mellitus
- current and/or chronic infections
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 |
|---|---|---|
| Lipid-lowering agents (Artovastatin)Also: TherapyArtovastatin 20 mg /day, orally, 12 consecutive weeks. | Drug | Exposed |
Primary outcome
Endothelial function
Time frame: 12 weeks
Ultrasound-based measurements of brachial reactivity were performed according to the guidelines of the International Brachial Artery Reactivity Task Force. The assessment of vascular reactivity was carried out by the same examiner. The left brachial artery was measured at a longitudinal section above the antecubital fossa, using a high-resolution ultrasound system Sequoia Echocardiography System, version 6.0, Acuson; Siemens, Vernon, CA) equipped with a multifrequency linear transducer (7-12 MHz) to produce two-dimensional images. This technique was used to evaluate the change in arterial diameter and blood flow after physical and pharmacological stimulation.
7 secondary outcomes
Side effects
Time frame: 12 weeks
Patient/Parent Global Activity
Time frame: 12 weeks
Physician Global Activity
Time frame: 12 weeks
Manual Muscle Testing
Time frame: 12 weeks
Muscle enzymes
Time frame: 12 weeks
Myositis Disease Activity Assessment Tool
Time frame: 12 weeks
Health Assessment Questionnaire
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- 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. This study is not recruiting at the moment.
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?
A study testing Lipid-lowering agents (Artovastatin) in people with Treatment Side Effects, 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Jun 2022. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 12 weeks). 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 3 Jun 2022.