Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,032 studies on the registry; 93 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Experimental
  Exposed

  Patients will receive lipid-lowering agents (Artovastatin) for at least 12-weeks

  Drug: Lipid-lowering agents (Artovastatin)

• No intervention
  No intervention

  Patients will not receive artovastatin (lipid-lowering agents)

Interventions

• DrugLipid-lowering agents (Artovastatin)

  Artovastatin 20 mg /day, orally, 12 consecutive weeks.

  Also known as: Therapy

Primary outcomes

1. 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.

   Time frame: 12 weeks

Secondary outcomes

1. Side effects

   Side effects of lipid-lowering agents

   Time frame: 12 weeks

2. 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.

   Time frame: 12 weeks

3. 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.

   Time frame: 12 weeks

4. 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.

   Time frame: 12 weeks

5. 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.

   Time frame: 12 weeks

6. 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)

   Time frame: 12 weeks

7. Health Assessment Questionnaire

   Especific questionnaire (health assessment questionnaire). Pontuaction 0.00-3.00

   Time frame: 12 weeks

Individual participant data

Plan to share: No