Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

NCT01813617 | Completed

• 2 other identifiers: SweMyoNet 1Centre of Care Science
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Polymyositis; Dermatomyositis

Keywords

Polymyositis; Dermatomyositis; Muscle endurance; Muscle stength; Outcome

Outcome Measures

Primary Outcomes (1)

• Functional Index 2 assessing change in muscle function over time.

  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 Outcomes (1)

• Manual Muscle test, MMT-8, assessing change in muscle function over time.

  0, 6 and 12 months

Other Outcomes (1)

• Physicians global assessment of disease activity assessing change over time.

  0, 6 and 12 months

Study Arms (1)

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

Interventions

Immunosuppressive Agents DRUG

Patients in the cohort received medical treatment according to standard care.

Also known as: Prednisone, Methotrexate, Azathioprine

Recent onset polymyositis and dermatomyositis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital, Solna

Stockholm, Stockholm County, 171 76, Sweden

Location

MeSH Terms

Conditions

Polymyositis; Dermatomyositis

Interventions

Immunosuppressive Agents; Prednisone; Methotrexate; Azathioprine

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Helene Alexanderson, PhD, RPT

  Karolinska University Hospital / Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RPT

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 19, 2013
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

SE (1)