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Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01813617
Recruitment Status : Completed
First Posted : March 19, 2013
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):
Helene Alexanderson, Karolinska University Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment
Polymyositis Dermatomyositis Drug: Immunosuppressive Agents

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study
Study Start Date : September 2010
Actual Primary Completion Date : June 2012

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:
  • Prednisone
  • Methotrexate
  • Azathioprine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01813617

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Karolinska University Hospital, Solna
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital
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Principal Investigator: Helene Alexanderson, PhD, RPT Karolinska University Hospital / Karolinska Institutet
Additional Information:

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Responsible Party: Helene Alexanderson, PhD, RPT, Karolinska University Hospital Identifier: NCT01813617    
Other Study ID Numbers: SweMyoNet 1
Centre of Care Science ( Registry Identifier: Swedish Myositis Network Register (SweMyoNet) )
First Posted: March 19, 2013    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013
Keywords provided by Helene Alexanderson, Karolinska University Hospital:
Muscle endurance
Muscle stength
Additional relevant MeSH terms:
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Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Immunosuppressive Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors