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Trial record 8 of 697 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Optimizing Treatment on Idiopathic Inflammatory Myopathies

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ClinicalTrials.gov Identifier: NCT03092180
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

Brief Summary:

As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.

This scheme is an internal routine protocol of our Service.


Condition or disease Intervention/treatment
Idiopathic Inflammatory Myopathies Drug: Intravenous Infusion

Detailed Description:
To compare two groups of patients as described in Brief Summary.

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing Treatment on Idiopathic Inflammatory Myopathies
Study Start Date : January 2005
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2026


Group/Cohort Intervention/treatment
Idiopathic inflammatory myopathies 1
Intravenous infusion with methyprednisolone / human intravenous immunoglobulin at disease onset
Drug: Intravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Other Name: Medicine

Idiopathic inflammatory myopathies 2
Intravenous infusion with methyprednisolone at disease onset
Drug: Intravenous Infusion
Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
Other Name: Medicine




Primary Outcome Measures :
  1. Physician Global Activity [ Time Frame: Six months ]
    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.

  2. Patient/Parent Global Activity - [ Time Frame: Six months ]
    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. Manual Muscle Testing [ Time Frame: Six months ]
    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.

  4. Health Assessment Questionnaire [ Time Frame: Six months ]
    Define the health assessement questionnaire. Pontuaction: 0.00-3.00

  5. Muscle Enzymes [ Time Frame: Six months ]
    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: Six months ]
    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)


Secondary Outcome Measures :
  1. Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin) [ Time Frame: Six months ]

Biospecimen Retention:   Samples With DNA

Serum and muscle biopsies

NOTE: This is a observational study. Subjects in the study will receive a routine care that has been established in our Instituition (diagnostic, therapeutic, biospecimen analysis and retention).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Idiopathic inflammatory myopathies
Criteria

Inclusion Criteria:

  • Idiopathic inflammatory myopathies

Exclusion Criteria:

  • Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

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): NCT03092180


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

Locations
Brazil
Samuel Katsuyuki Shinjo Recruiting
Sao Paulo, Brazil, 01246903
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: NCT03092180     History of Changes
Other Study ID Numbers: MYO-HCFMUSP-01
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo:
Dermatomyositis
Immunomodulation
Immunosuppressive agents
Myositis
Polymyositis
Necrotizing myopathies
Antisynthetase syndrome

Additional relevant MeSH terms:
Muscular Diseases
Myositis
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs