Health TrialsbyHealthPanel

Optimizing Treatment on Idiopathic Inflammatory Myopathies

ConditionIdiopathic Inflammatory Myopathies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Idiopathic inflammatory myopathies

Disqualifiers

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

Trial population

Idiopathic inflammatory myopathies

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Intravenous Infusion

    Drug

    Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Idiopathic inflammatory myopathies 11 intervention
Group B: Idiopathic inflammatory myopathies 21 intervention

Trial outcomes

Primary outcomes

1

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
Six months
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
Six months
3

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
Six months
4

Health Assessment Questionnaire

Define the health assessement questionnaire. Pontuaction: 0.00-3.00

Time frame
Six months

Secondary outcomes

1

Side effects to treatment (glucocorticoid, immunosuppressants and/or human intravenous immunoglobulin)

Effect of drugs in disease outcomes

Time frame
Six months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov
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