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Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

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ClinicalTrials.gov Identifier: NCT03092154
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Treatment Side Effects Drug: Lipid-lowering agents (Artovastatin) Not Applicable

Detailed Description:
Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups: with or without lipid-lowering agents
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Exposed
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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 12 weeks ]
    Side effects of lipid-lowering agents

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)

  7. Health Assessment Questionnaire [ Time Frame: 12 weeks ]
    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Samuel K Shinjo, PhD 55-11-3061-7176 samuel.shinjo@gmail.com

Locations
Brazil
Samuel Katsuyuki Shinjo Recruiting
Sao Paulo, Brazil, 01246903
Contact: Samuel K Shinjo, PhD    55-11-3061-7176    samuel.shinjo@gmail.com   
Sub-Investigator: Isabela BP Borges         
Sub-Investigator: Marilda G Silva         
Sub-Investigator: Rafael G Misse         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Samuel K Shinjo, PhD Universidade de Sao Paulo - Rheumatology Division

Responsible Party: Samuel Katsuyuki Shinjo, PhD, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03092154     History of Changes
Other Study ID Numbers: MYO-HCFMUSP-03
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Myositis
Dermatomyositis
Polymyositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents