Condition category
Musculoskeletal Diseases
Date applied
29/06/2017
Date assigned
26/07/2017
Last edited
09/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Polymyalgia rheumatic is a condition that causes swelling, pain and stiffness in parts of the body, such as the shoulders, hips or neck. It affects men and women above the age of 50 and is the most common chronic inflammatory disease in this age group. If left untreated, the disease is very unpleasant and causes by aching, stiff and tender muscles. Treatment with steroids (treatment for swelling) is effective but long-term treatment is required, which may be associated with serious adverse (unwanted) effects. The aim of this study is to extend the understanding of what happened to people with PMR, by profiling the gene expression in muscle tissue from patients who have not taken steroids with PMR and matched non-PMR participants before and after symptom-eliminating treatment with prednisolone (a type of steroid).

Who can participate?
Patients aged 50 years and older who have aching or stiffness in the neck, shoulders, hips or thighs for one month or more and adults aged 50 and older without PMR and healthy adults aged 50 and years and older.

What does the study involve?
Participant receive daily 20 mg prednisolone tablets that they take daily for 14 days. Participants are invited for a visit at the research center twice: once before and once after treatment with the treatment. During the two visits, blood samples are taken and a single muscle biopsy is taken from muscle tissue in the neck/shoulder (trapezius) muscles or the thigh muscles.

What are the possible benefits and risks of participating?
Participants receive 500 Danish kroners for participating. There are no notable risks with participating.

Where is the study run from?
Bispebjerg Hospital (Denmark)

When is the study starting and how long is it expected to run for?
January 2005 to June 2017

Who is funding the study?
1. Danish Rheumatism Association (Gigtforeningen) (Denmark)
2. Nordea Foundation (Nordea-fonden) (Denmark)
3. Medical Sciences, Danish Council for Independent Research, (Sundhed og Sygdom, Det Frie Forskningsråd) (Denmark)

Who is the main contact?
Prof. Henrik Galbo

Trial website

Contact information

Type

Public

Primary contact

Prof Henrik Galbo

ORCID ID

Contact details

Institute for Inflammation Research
Tagensvej 20
Copenhagen
DK-2100
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PMR1

Study information

Scientific title

Gene expression in patients with polymyalgia rheumatica and control subjects before and after glucocorticoid treatment

Acronym

Study hypothesis

The aim of this study is to extend the understanding of the pathophysiology of PMR, by profiling the gene expression in muscle tissue from glucocorticoid-naive patients with PMR and matched non-PMR control subjects before and after symptom-eliminating treatment with prednisolone.

Ethics approval

Ethical Committee of Copenhagen Denmark, 15/04/2005, ref: KF[01]261665

Study design

Interventional single-centre exploratory research trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Polymyalgia rheumatica

Intervention

Participants are allocated to groups based on their diagnosis. Participants (the patients and the control participants) receive an open-label, once-daily prednisolone tablets 20 mg/day for 14 days.

Participants are invited for a visit at the research center twice, once before and once after treatment with the treatment usually prescribed for the disease. During the two visits, blood samples are taken and a single muscle biopsy will be taken from muscle tissue in the neck/shoulder (trapezius) muscles or the thigh muscles.

The two groups are compared to see the pathophysiology of PMR.

Intervention type

Drug

Phase

Not Applicable

Drug names

Glucocorticoids (prednisolone)

Primary outcome measures

Gene expression is measured in symptomatic muscle tissue using the microarray and quantitative real-time PCR methods at baseline and 14 days.

Secondary outcome measures

1. Erythrocyte sedimentation rate is measured using standard clinical laboratory procedures at baseline and 14 days
2. C-reactive protein is measured using standard clinical laboratory procedures at baseline and 14 days
3. Clinical symptoms is evaluated by a trained rheumatologist at baseline and 14 days

Overall trial start date

01/01/2005

Overall trial end date

10/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Age 50 years or older
2. Bilateral aching and stiffness persisting for 1 month or more involving two of the following areas: neck or torso, shoulders or proximal regions of the arms, and hips or proximal aspects of the thighs
3. Erythrocyte sedimentation rate >40 mm/h
4. Exclusion of other diagnoses except giant cell arteritis

Control participants:
Aged 50 years or older

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

20

Participant exclusion criteria

Patients and control participants:
1. Prior treatment with glucocorticoids
2. Diagnosis of GCA based on obligatory temporal artery biopsy (patients only)
3. Inflammatory conditions other than PMR
4. Cancer during the past 5 years
5. Neuromuscular disease
6. Severe infections
7. Hereditary disposition for type 2 diabetes
8. Thyroid disease
9. Disturbance of calcium homeostasis
10. Uncontrolled hypertension
11. Use of drugs with potential effects on the study parameters

Recruitment start date

01/09/2005

Recruitment end date

01/10/2007

Locations

Countries of recruitment

Denmark

Trial participating centre

Bispebjerg Hospital
Institute of Sports Medicine
Copenhagen
DK-2400
Denmark

Sponsor information

Organisation

Bispebjerg Hospital

Sponsor details

Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Gigtforeningen

Alternative name(s)

Danish Rheumatism Association

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

Denmark

Funder name

Nordea-fonden

Alternative name(s)

Nordea Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Denmark

Funder name

Sundhed og Sygdom, Det Frie Forskningsråd

Alternative name(s)

Medical Sciences, Danish Council for Independent Research, Det Frie Forskningsråd, Sundhed og Sygdom, Danish Council for Independent Research, Medical Sciences, DFF, Sundhed og Sygdom, Danish Health Sciences Research Council, Danish Medical Research Council, FSS, DFF

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Denmark

Results and Publications

Publication and dissemination plan

Manuscript in late-stage peer review.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository ArrayExpress at http://www.ebi.ac.uk/arrayexpress/experiments/E-MTAB-3671. The type of data stored is the raw gene expression levels values. This will made publicly available when the paper is published in the journal. Participants gave general informed consent that covers the publication of the research results in a completely anonymised format.

Intention to publish date

01/08/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28784116

Publication citations

Additional files

Editorial Notes

09/08/2017: Publication reference added.