Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01171573 |
| Other study ID # |
Ollier-002 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2001 |
| Est. completion date |
December 2030 |
Study information
| Verified date |
April 2023 |
| Source |
Northern Care Alliance NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)belong to a group of
inflammatory muscle disorders, of unknown cause, that are characterised by skeletal muscle
inflammation and progressive muscular weakness, which can be debilitating and chronic in
nature (occasionally fatal).
The current treatment options for these conditions are steroids and various other
immunosuppressive drugs. However, these are usually only partially effective at reducing
symptoms, and their toxic side effects also limit their usefulness. In order to develop more
specific treatments for myositis in the future (and therefore more effective), it is
important to understand the exact mechanisms that cause the disease in the first instance. In
other similar inflammatory diseases such as rheumatoid arthritis (RA) and systemic lupus
(SLE), it is known that changes to the Human Leukocyte Antigen(HLA), as well as certain
inflammatory cytokines, are involved in both the development and expression of the disease.
As many of the inflammatory mechanisms that cause damage in PM, DM and IBM are similar to
those in RA and SLE, it seems likely that similar genetic factors will also be involved in
the development and expression of PM, DM and IBM.
In order to understand the genetic aspects / causes of myositis, and ultimately develop more
effective treatment therapies in the future, patients with PM, DM or IBM, will be asked to
give 20 mls of blood. These blood samples, along with the patient's clinical details, will
then be sent to the Centre for Integrated Genomic Medical Research (CIGMR), at The University
of Manchester, where all of the genetic analyses will take place. By understanding the
genetic cause of the disease, it should be possible to design specific drugs for treating the
condition in the future.
Description:
In order to understand the genetic aspects / causes of myositis, and ultimately develop more
effective treatment therapies, it will be necessary to collect blood samples and clinical
details from around 1000 patients with myositis. As the condition is very rare, it will not
be possible to get the required number of patients from one centre alone, and therefore, a
collaborative, multicentred approach will be needed. Consultant rheumatologists and
neurologists throughout the UK, who have patients with PM, DM or IBM, will be approached, and
asked if they would like to officially enter into the myositis genomic multicentred study.
Once ethical and R&D approval has been granted, consultants will be named as the 'Principal
Investigators' at each of these 'research sites' and could then start to recruit suitable
patients into the study.
Patients from each research site, with definite PM, DM or IBM, will be asked by their own
consultants (Principal Investigator) to give 20 mls of blood via venepuncture for genetic and
antibody analysis. The PI will also complete a clinical/laboratory proforma, for each
patient, regarding their disease characteristics, to allow subsequent confirmation that
patients' disease is indeed definite, and this proforma and the blood sample will be sent to
CIGMR. All of the genetic analyses, will take place at CIGMR, but storage of clinical details
and certain patient identifiers will be stored at SRFT on a password protected NHS tust
computer.
This study will be co-ordinated by Dr RG Cooper through the Rheumatic Diseases Centre,
Salford Royal NHS Foundation Trust (SRFT), and Professor Bill Ollier from the Centre for
Integrated Genomic Medical Research unit (CIGMR), Stopford Building, Manchester University.
