Gene expression profiling in patients with polymyalgia rheumatica before and after symptom-abolishing glucocorticoid treatment
| ISRCTN | ISRCTN69503018 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69503018 |
| Secondary identifying numbers | PMR1 |
- Submission date
- 29/06/2017
- Registration date
- 26/07/2017
- Last edited
- 09/08/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Public
Institute for Inflammation Research
Tagensvej 20
Copenhagen
DK-2100
Denmark
Study information
| Study design | Interventional single-centre exploratory research trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Gene expression in patients with polymyalgia rheumatica and control subjects before and after glucocorticoid treatment |
| Study objectives | 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(s) | Ethical Committee of Copenhagen Denmark, 15/04/2005, ref: KF[01]261665 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Glucocorticoids (prednisolone) |
| Primary outcome measure | 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 study start date | 01/01/2005 |
| Completion date | 10/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 20 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/10/2007 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Copenhagen
DK-2400
Denmark
Sponsor information
Hospital/treatment centre
Bispebjerg Bakke 23
Copenhagen
DK-2400
Denmark
"ROR" |
https://ror.org/00td68a17 |
|---|
Funders
Funder type
Industry
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- Danish Rheumatism Association
- Location
- Denmark
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Nordea Foundation
- Location
- Denmark
Government organisation / National government
- Alternative name(s)
- Det Frie Forskningsråd, Sundhed og Sygdom, DFF, Sundhed og Sygdom, Medical Sciences, Danish Council for Independent Research, Danish Council for Independent Research, Medical Sciences, Danish Health Sciences Research Council, Danish Medical Research Council, FSS, DFF
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/08/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Manuscript in late-stage peer review. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/08/2017 | Yes | No |
Editorial Notes
09/08/2017: Publication reference added.
