Back to resultsLipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Primary Purpose
Treatment Side Effects
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Lipid-lowering agents (Artovastatin)
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Side Effects
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
Patients with:
- disease relapsing
- overlapping myositis
- neoplasia associated myositis
- diabetes mellitus
- current and/or chronic infections
- 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
Sites / Locations
- Samuel Katsuyuki Shinjo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exposed
No intervention
Arm Description
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
Patients will not receive artovastatin (lipid-lowering agents)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Side effects
Side effects of lipid-lowering agents
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.
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.
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.
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.
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)
Health Assessment Questionnaire
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03092154
Brief Title
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Official Title
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Side Effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: with or without lipid-lowering agents
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exposed
Arm Type
Experimental
Arm Description
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Patients will not receive artovastatin (lipid-lowering agents)
Intervention Type
Drug
Intervention Name(s)
Lipid-lowering agents (Artovastatin)
Other Intervention Name(s)
Therapy
Intervention Description
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
Primary Outcome Measure Information:
Title
Endothelial function
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Side effects
Description
Side effects of lipid-lowering agents
Time Frame
12 weeks
Title
Patient/Parent Global Activity
Description
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.
Time Frame
12 weeks
Title
Physician Global Activity
Description
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.
Time Frame
12 weeks
Title
Manual Muscle Testing
Description
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.
Time Frame
12 weeks
Title
Muscle enzymes
Description
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.
Time Frame
12 weeks
Title
Myositis Disease Activity Assessment Tool
Description
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)
Time Frame
12 weeks
Title
Health Assessment Questionnaire
Description
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with:
disease relapsing
overlapping myositis
neoplasia associated myositis
diabetes mellitus
current and/or chronic infections
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo, PhD
Organizational Affiliation
Universidade de Sao Paulo - Rheumatology Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel Katsuyuki Shinjo
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
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