NCT00847236

Brief Summary

The aim of this study is to evaluate a simple and rapid method in order to better define and treat Polymyalgia Rheumatica by measuring levels of muscle achiness and pain with a blood pressure cuff.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

4.6 years

First QC Date

February 18, 2009

Last Update Submit

August 22, 2017

Conditions

Polymyalgia RheumaticaRheumatoid ArthritisRheumatic Disease

Keywords

Polymyalgia RheumaticaRheumatoid ArthritisRheumatic DiseasePMR

Outcome Measures

Primary Outcomes (1)

  • To define whether the measurement of proximal arm tenderness can be used to diagnose and treat patients with Polymyalgia Rheumatica

    One to two visits each subject

Secondary Outcomes (1)

  • Assessing the ease of measuring proximal arm tenderness

    One to two visits each subject

Study Arms (3)

Subjects with Polymyalgia Rheumatica

50 subjects with Polymyalgia Rheumatica, both acute and chronic

Subjects w/o Polymyalgia Rheumatica

50 subjects with Rheumatic Disease other than polymyalgia Rheumatica

Subjects w/o Rheumatic Disease

50-Non Rheumatic disease subjects

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients and Healthy volunteers from colleague referral and own practice

You may qualify if:

  • Patients signing Informed Consent

You may not qualify if:

  • Patients less than 50 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Arlington

Arlington, Massachusetts, 02474, United States

Location

MeSH Terms

Conditions

Polymyalgia RheumaticaArthritis, RheumatoidRheumatic Diseases

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesArthritisJoint DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Gerald S. Harris, M.D.

    Lahey Clinic, Inc. Arlingtion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

US(1)