Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03092154|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment Side Effects||Drug: Lipid-lowering agents (Artovastatin)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two groups: with or without lipid-lowering agents|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks
Drug: Lipid-lowering agents (Artovastatin)
Artovastatin 20 mg /day, orally, 12 consecutive weeks.
Other Name: Therapy
No Intervention: No intervention
Patients will not receive artovastatin (lipid-lowering agents)
- 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.
- Side effects [ Time Frame: 12 weeks ]Side effects of lipid-lowering agents
- Patient/Parent Global Activity [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]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 [ Time Frame: 12 weeks ]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: 12 weeks ]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 [ Time Frame: 12 weeks ]Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092154
|Contact: Samuel K Shinjo, PhDemail@example.com|
|Samuel Katsuyuki Shinjo||Recruiting|
|Sao Paulo, Brazil, 01246903|
|Contact: Samuel K Shinjo, PhD 55-11-3061-7176 firstname.lastname@example.org|
|Sub-Investigator: Isabela BP Borges|
|Sub-Investigator: Marilda G Silva|
|Sub-Investigator: Rafael G Misse|
|Principal Investigator:||Samuel K Shinjo, PhD||Universidade de Sao Paulo - Rheumatology Division|