Completed

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

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What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Connective Tissue Diseases+7

+ Muscular Diseases

+ Musculoskeletal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2010
See protocol details

Summary

Principal SponsorKarolinska University Hospital
Last updated: March 19, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01813617
Principal SponsorKarolinska University Hospital
Last updated: March 19, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

72 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Connective Tissue DiseasesMuscular DiseasesMusculoskeletal DiseasesMyositisNervous System DiseasesNeuromuscular DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDermatomyositisPolymyositis

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Karolinska University Hospital, Solna

Stockholm, SwedenOpen Karolinska University Hospital, Solna in Google Maps
CompletedOne Study Center