Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helene Alexanderson, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01813617
First received: March 13, 2013
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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 Intervention
Polymyositis
Dermatomyositis
Drug: Immunosuppressive Agents

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Functional Index 2 assessing change in muscle function over time. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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:
  • Manual Muscle test, MMT-8, assessing change in muscle function over time. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: No ]
    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:
  • Physicians global assessment of disease activity assessing change over time. [ Time Frame: 0, 6 and 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 72
Study Start Date: September 2010
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813617

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

No publications provided

Responsible Party: Helene Alexanderson, PhD, RPT, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01813617     History of Changes
Other Study ID Numbers: SweMyoNet 1, Centre of Care Science
Study First Received: March 13, 2013
Last Updated: March 14, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska University Hospital:
Polymyositis
Dermatomyositis
Muscle endurance
Muscle stength
Outcome

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Azathioprine
Methotrexate
Immunosuppressive Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014