Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01813617
• Date of registration: 13/03/2013
• Prospective Registration: No
• Primary sponsor: Karolinska University Hospital
• Public title: Outcome in Patients With Recent Onset Polymyositis and Dermatomyositis
• Scientific title: Outcome of Muscle Function and Disease Activity in Patients With Recent Onset Polymyositis and Dermatomyositis - a 1-year Follow-up Register Study
• Date of first enrolment: September 2010
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01813617
• Study type: Observational [Patient Registry]
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Helene Alexanderson, PhD, RPT
• Affiliation: Karolinska University Hospital / Karolinska Institutet

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dermatomyositis

Polymyositis

Intervention(s)

Drug: Immunosuppressive Agents

Primary Outcome(s)

Functional Index 2 assessing change in muscle function over time. [Time Frame: 0, 6 and 12 months]

Secondary Outcome(s)

Manual Muscle test, MMT-8, assessing change in muscle function over time. [Time Frame: 0, 6 and 12 months]

Secondary ID(s)

SweMyoNet 1

Centre of Care Science

Source(s) of Monetary Support

Please refer to primary and secondary sponsors