Treatment Side Effects and Changes to Physical Function in Newly-Diagnosed Polymyalgia Rheumatica

Not Applicable

Completed

• Conditions: Polymyalgia Rheumatica; Sarcopenia; Inflammatory and Immune System - Autoimmune diseases; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12618001522202
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-11
• Study Completion: 2023-07-30
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

For PMR participants:
Diagnosis of PMR (as defined by the 2012 EULAR/ACR Classification Criteria)
AND
Commencement of prednisolone for PMR treatment <12 weeks prior

For control participants:
Age- and gender-matched to PMR participants

Exclusion Criteria

For PMR participants:
•Prior diagnosis or current symptoms suggestive of Giant Cell Arteritis (GCA [including headache, jaw claudication, scalp tenderness or sudden visual disturbance]);
•Active malignancy;
•Active infection;
•Active neuromuscular disease;
•Other inflammatory/autoimmune conditions requiring immunosuppression e.g. Rheumatoid Arthritis (RA);
•Chronic pain syndromes;
•Prior or current treatment with concomitant Disease Modifying Anti-Rheumatic Drugs (DMARD).

For Control Participants:
•Current or prior diagnosis of PMR;
•Current or prior diagnosis of GCA;
•Any condition requiring regular systemic glucocorticoids;
•Active malignancy;
•Active infection;
•Active neuromuscular disease;
•Any inflammatory/autoimmune conditions requiring immunosuppression e.g. Rheumatoid Arthritis (RA);
•Chronic pain syndromes.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For participants who were not already sarcopenic, the proportion who have developed sarcopenia at the 78-week assessment o EWGSOP definition of sarcopenia o FNIH definition of sarcopenia[ 78 weeks after initial assessment];Prevalence of sarcopenia at 78-week assessment o EWGSOP definition of sarcopenia o FNIH definition of sarcopenia[ 78 weeks after initial assessment]