Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

March 14, 2013 updated by: Helene Alexanderson, Karolinska University Hospital

Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study

Most patients respond to medical treatment with corticosteroids and immunosuppressive treatment, but a majority of patients develop sustained muscle impairment. The aim of this study was to evaluate the outcome of muscle endurance assessed with the Functional Index-2 (FI-2), muscle strength assessed by the MMT-8 and disease activity assessed by the six item core set at 6 and 12 months following diagnosis in patients with polymyositis (PM) and dermatomyositis (DM).

72 patients diagnosed with probable or definite PM or DM 2003-2010 who performed the FI-2 and the MMT at the time of diagnosis were included in this Swedish Myositis Register study. All patients had performed both the Functional Index-2 assessing muscle endurance and the Manual Muscle test (MMT) assessing isometric muscle strength. Physician Global assessment based on the evaluation of the consensus recommended six item core set for disease activity assessment was also included. Data were analysed on group levels as well as with criteria for individual responder criteria. A responder was identified as improving at least 20 % compared to baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to investigate the degree of impairment of isometric muscle weakness and dynamic muscle endurance in patients with recent onset PM and DM and to evaluate how muscle impairment and disease activity changes during the first year following diagnosis of PM or DM. A further aim was to investigate the association between muscle impairment, disease activity and autoantibodies in these patients.

All patients diagnosed with definite or probable PM or DM according to Bohan and Peter criteria (Bohan and Peter 1975) 2003-2010, at the Rheumatology clinic at Karolinska University Hospital, also included in the Swedish Rheumatology Register (SweMyoNet) who had performed measures of dynamic muscle endurance by the FI-2 and isometric muscle strength by the MMT-8 were included in this register study (n=71).

Functional Index-2 is a disease specific, valid and reliable instrument assessing muscular endurance in seven muscle groups including seven tasks; shoulder flexion, shoulder abduction, neck flexion, hip flexion, step test and toe lifts and heel lifts. Each muscle group are scored as the number of correctly executed repetitions.

The six-item core set for measures of disease activity include; Physician's and patient's assessment of disease activity on a Visual Analogue Scale (VAS), the Manual Muscle Test (MMT), the Stanford Health Assessment Questionnaire (HAQ), analyses of muscle enzymes and the extra-muscular disease activity scores Myositis Disease Activity Visual Analogue Scales (MYOACT) or the Myositis Intention to Treat Index (MITAX). The 8-muscle group MMT was performed on the dominant body side including muscle groups; neck flexors, deltoids, biceps brachia, dorsi flexors of the wrist, gluteus maximus and medius, quadriceps and dorsi flexors of the ankle. Total score varies between 0 and 80, where 80 indicate normal muscular strength.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska University Hospital, Solna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with polymyositis or dermatomysitis at the Karolinska University Hospital 2003-2010.

Description

Inclusion Criteria:

  • Probable or definite polymyositis and dermatomyositis
  • Performed both the FI-2 and the MMT at time of diagnosis

Exclusion Criteria:

  • Patients with diagnosis inclusions body myositis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Recent onset polymyositis and dermatomyositis
Patients in this cohort was diagnosed with polymyositis or dermatomyositis during 2003-2010 and was treated with corticosteroids and other immunosuppressive agents according to standard care. They were all diagnosed and treated at the Rheumatology Clinic, Karolinska University Hospital.
Drug: Immunosuppressive Agents
Patients in the cohort received medical treatment according to standard care.
Other Names:
  • Methotrexate
  • Prednisone
  • Azathioprine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Index 2 assessing change in muscle function over time.
Time Frame: 0, 6 and 12 months
The FI-2 is a disease-specific assessment of dynamic muscle endurance in 7 muscle groups and records the number of correct performed repetitions for each muscle group.
0, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Manual Muscle test, MMT-8, assessing change in muscle function over time.
Time Frame: 0, 6 and 12 months
Measure isometric muscle strength in 8 muscle groups and is scored between 0-10 for each muscle group with a total score of 80 indicating godd muscle strength.
0, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physicians global assessment of disease activity assessing change over time.
Time Frame: 0, 6 and 12 months
Physician's global assessment is included in the consensus proposed six item core set of disease activity measures also including patient's global assessment, the MMT, Health Assessment Questionnaire (HAQ), analysis of muscle enzymes and the extra-muscular disease activity tools MITAX or MYOACT.
0, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

March 14, 2013

First Posted (Estimate)

March 19, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 14, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SweMyoNet 1
  • Centre of Care Science (Registry Identifier: Swedish Myositis Network Register (SweMyoNet))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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