4th edition new draft.pub - The University of Manchester

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Issue 4
May 2011
Welcome to the 4th edition of the
Musculoskeletal Local Speciality Group
Newsletter
In this issue….
∗
∗
Studies to recruit to—advertise your study here!!
Uploading accrual for studies starting pre-2008
∗ Recruitment figures 2009-2010 and 2010-2011:
a comparison
∗
∗
A look at the new year so far—2011-2012
Congratulations to our top recruiting non-commercial
studies!!
∗ Commercial study accrual update 2010-2011
∗
∗
Introducing...New Musculoskeletal research nurses
Musculoskeletal Research Practitioner Workshop:
Feedback

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Studies to recruit to
BILAG Biologics Register (BILAG BR)
Short title: BILAG Biologics Prospective Cohort
Full title of the research: BILAG Biologics Prospective Cohort: The Use of Novel
Biological Therapies in the Treatment of Systemic Lupus Erythematosus (SLE)
REC Reference Number: 09/H1014/64
CSP reference: 24407
UK CRN ID: 8251
The BILAG Biologics Prospective Cohort is a prospective observational cohort study of
patients with SLE who are starting treatment with a biologic drug or a conventional, nonbiologic
therapy. The study aims to recruit 220 patients into the biologic treatment group
and a further 220 patients into the conventional, non-biologic therapy cohort.
The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment
of SLE is associated with an increased risk of hospitalisation for infection, compared to
SLE patients with similar disease activity receiving conventional therapies. The
secondary purpose of the BILAG Biologics Prospective Cohort is to determine the longterm
efficacy of biological therapies in the treatment of SLE.
This prospective cohort study will recruit an exposed cohort of patients with SLE treated
with biological therapies and an unexposed cohort of patients with similar disease
characteristics but exposed only to conventional non-biological therapies.
Comprehensive data will be collected at baseline, from the clinic team and the patient,
including data on disease diagnosis and activity, risk factors for infection and routine
laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to
include any changes in medications, adverse events, hospitalisations for infections,
disease activity and quality of life along with biological samples for biomarker analysis.
Contact
If you would like any additional information regarding the study, please contact Emily
Sutton, BILAG BR Study Coordinator.
Email: Emily.sutton@manchester.ac.uk
Tel: 0161 3061916
Fax: 0161 2751640
BILAG BR
Arthritis Research UK Epidemiology Unit
The University of Manchester
Rutherford House (Unit 4)
Manchester Science Park
40 Pencroft Way
MANCHESTER
M15 6SZ

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Studies to recruit to
MYOSITIS GENETICS STUDY
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. 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 and lupus, 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, are being 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.
For further information about recruiting to this study (portfolio ID 7996)
please contact Paul New at Salford Royal NHS Foundation Trust at:-
Email: Paul.new@srft.nhs.uk
Telephone: 0161 206 4295

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Studies to recruit to
ESOS (European Scleroderma Observational Study) is a new prospective
observational study comparing treatment outcomes in early diffuse
cutaneous systemic sclerosis (dcSSc). The study is funded as part of
the EULAR Orphan Disease Programme, which aims to improve knowledge
of the pathogenesis and treatment of SSc. It has been accepted onto the
NIHR Portfolio (ID 8799) under the musculoskeletal topic.
ESOS is coordinated by the University of Manchester and will involve
the documentation of current best practice (using a web-based data
collection system) in patients with early dcSSc. The four treatment
protocols being recruited are; methotrexate, mycophenolate mofetil,
cyclophosphamide, and also those receiving no immunosuppressant
treatment. Recruitment started in July 2010 in centres across Europe and
will continue for the next 2 years.
If you have a patient with early dcSSc (defined as within 3 years of the
onset of skin thickening) who might be eligible you can:
Visit the study website: http://www.ssc-esos.net
Or
E-mail the study co-ordinator: holly.ennis@manchester.ac.uk

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Studies to recruit to

6
Uploading accrual for studies starting pre-2008
After review of the National Musculoskeletal
Disorders Speciality Group portfolio, it became
evident that several studies that started prior to
the set-up of the NIHR portfolio were being
highlighted as under-recruiting to target. For many studies,
recruitment figures prior to 2008 were not being uploaded,
thereby affecting the % recruitment to target.
NIHR CRN CC guidelines on uploading recruitment data to the
standard template spreadsheet states “Running total - The total
of the number of participants that have been recruited into the
study. If recruitment began before April 2008, the running total
should also include all participants recruited before this date
(not all participants will be listed in the spreadsheet, but all
participants should be counted in the running total)…..The
running total is used to generate the Total accrual to date
percentage bar displayed on the study record in the public
Portfolio database.”
And in the FAQ section of the guidelines it states “As
activity-based funding allocations to CLRNs will be based on
activity from 1 April 2008, a line of data is required for every
study participant recruited after 31 March 2008. We encourage
study coordinators to provide a line of data for each participant
recruited prior to April 2008 in order to provide baseline data.
Where this is not possible we request that total numbers of
recruits are submitted wherever possible. When providing total
numbers these should be submitted to the accrual team as two
figures; recruitment for April 2007 to March 2008 and
recruitment prior to April 2007. Totals should include all
recruitment, including international recruits”
You can review these guidelines in full by going to:
http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_recruitment/
If you are experiencing specific problems with uploading your
recruitment you can contact the portfolio team at:
ccrn.portfolio@nihr.ac.uk

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Recruitment figures 2009-2010 and 2010-2011: a comparison
140
120
100
Recruitment
80
60
40
20
0
2009-2010
2010-2011
Month
Nationally many studies are co-adopted between Musculoskeletal and other topics—Please note
that the above graph includes co-adopted study involvement
A look at the new year so far—2011-2012
25
25
20
Recruitment
15
10
5
0
1
2
4 4
1
15
4
1
3
11
4 4
2
1
3
3
Apr-11
May-11
Study

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Top recruiting non-commercial studies 2010-2011
140
120
100
80
60
40
20
0
BRAGGSS
Developing
the UK-EDAQ
for arthritis
Trace RA
Endogenous
pain control
mechanisms
PAALS
National
Repository
portfolio
ID
Acronym Title Top
recruiting
site
5114 BRAGGSS Investigation of genes influencing
response to treatment with Infliximab,
Etanercept and Adalumimab in patients
with rheumatoid arthritis and related
arthropathies
Manchester
Royal
Infirmary
7084 EDAQ Developing the UK-EDAQ for arthritis North
Manchester
General
Hospital
4076 Trace RA Trial of Atorvastatin for the primary
prevention of Cardiovascular Events in
Rheumatoid Arthritis
4786 Endogenous pain control mechanisms in
patients with chronic arthritic pain
North
Manchester
General
Hospital
Salford
Royal
(Hope)
Hospital
single
centre
8894 PAALS Pain Across the Adult Life Span Central
Local PI/Invetigator
Professor Ian
Bruce
Professor Alison
Hammond/ Denise
McSorland
(research nurse)
Dr Beverley
Harrison/ Lorraine
Lock/Denise
McSorland
(research nurses)
Dr Alison Watson
Dr John McBeth
7881 National
Repository
Investigation of clinical, serological and
genetic factors in the development of
arthritis and rheumatic diseases
Mancheter/
Wellcome
Trustsingle
centre
Manchester
Royal
Infirmary
Professor Ian
Bruce/Dr Pauline
Ho

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Commercial study accrual update 2010-2011
26
1 1 1 1 2 4
7
CCRN 098
CCRN 099
MCRN067
MCRN069
CCRN 092
CCRN 078
17
PCRN010
CCRN 097
20
18
CCRN 067
CCRN 065
CCRN 100
Study ID Acronym Study Title Active Status Recruiting sites
CCRN 092
A multi-centre, randomised, double-blind,
parallel group study of the safety, remission
and prevention of structural joint damage
during treatment with tocilizumab (TCZ), as a
monotherapy and in combination with
methotrexate (MTX), versus MTX in patients
with early, moderate to sever rheumatoid
Trafford General
6915 (RA) arthritis.
Open Hospital
6983
6985
CCRN 099
(PRAD)
CCRN 100
(PRAD 2)
Observational cohort study to evaluate the
safety and efficacy of Pradaxa (dabigatran
etexilate) in patients with moderate renal
impairment (creatinine clearance 30-50ml/min)
undergoing elective total hip replacement
surgery or total knee replacement surgery Open
Observational cohort study to investigate the
safety and efficacy of Pradaxa (dabigatran
etexilate) for the prevention of venous
thromboembolism in patients undergoing
elective total hip replacement surgery or total
knee replacement surgery in a clinical setting. Open
Wrightington
Hospital
Wrightington
Hospital
7770 MCRN069
6939 PCRN010
An open-label extension study of canakinumab
(ACZ885) in patients with Systemic Juvenile
Idiopathic Arthritis (SJIA) and active systemic
manifestations
Open
A randomised open-label study to evaluate the
safety and efficacy of denosumab and monthly
actonel® therapies in postmenopausal women
transitioned from weekly or daily alendronate
therapy
Open
Royal Manchester
Children's Hospital
Synexus
Manchester Clinical
Research Centre

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Commercial study accrual update 2010-2011
Study ID Acronym Study Title Active Status Recruiting sites
An open-label study assessing the addition of
subcutaneous golimumab (GLM) to
conventional disease-modifying antirheumatic
drug (DMARD) therapy in biologic-naïve
subjects with rheumatoid arthritis (Part 1)
followed by a randomised study assessing the
value of combined intravenous and
subcutaneous GLM administration aimed at
inducing and maintaining remission (Part 2)
6678
CCRN 065
(RA)
Closed - in
follow-up
Manchester Royal
Infirmary/
Wrightington
Hospital
6681
CCRN 067
(RA)
A 3-phase study to evaluate sustained
remission and productivity outcomes in
subjects with early rheumatoid arthritis initiated
on treatment with etanercept plus
Closed - in
methotrexate
follow-up
Manchester Royal
Infirmary/
Wrightington
Hospital
6887
CCRN 078
(Tendon
repair)
A randomised, double blind clinical
investigation to evaluate the safety, tolerability,
and preliminary performance of Adaprev in
Improving recovery of tendon function in
subjects undergoing surgical repair of flexor
tendons in Zone II of the hand
Closed - in
follow-up
Wythenshawe
Hospital
6989
CCRN 097 (RA
- TNF)
A global multi-centre observational study in
rheumatoid arthritis (RA) patients who are
non-responders or intolerant to a single tumor
necrosis factor (TNF)-inhibitor
Closed - in
follow-up
Manchester Royal
Infirmary/ Salford
Royal Hospital/
Stepping Hill
Hospital/
Wrightington
Hospital
6969
Efficacy and safety of eslicarbazepine acetate
as therapy in patients with fibromyalgia: A
CCRN 098 double-blind, randomised, placebo-controlled,
(Fibromyalgia) parallel-group, multicentre clinical trial
Closed - in
follow-up
Manchester Royal
Infirmary
7768 MCRN067
A randomized, double-blind, placebo controlled,
withdrawal study of flare prevention of
canakinumab (ACZ885) in patients with
Systemic Juvenile Idiopathic Arthritis (SJIA) and Closed - in
active systemic manifestations
follow-up
Royal Manchester
Children's Hospital

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Introducing the new research nurses
There have been several new Musculoskeletal research nurses appointed in
2011. Let us introduce…….
Name: Jane McConniffe
Base: Arthritis research UK Epidemiology Unit, The University of
Manchester
Role: Peripatetic research nurse. Jane’s role is to travel to sites across
Greater Manchester assisting with screening and recruitment to studies on
the Musculoskeletal portfolio.
Name: Lindsey Barber
Base: Stockport NHS Foundation Trust, Stepping Hill Hospital
Role: Lindsey’s role is to develop and maintain the Musculoskeletal
portfolio at Stepping Hill Hospital. She will be recruiting to TOPKAT (Total
Or Partial Knee Arthroplasty Trial) as well as some other Rheumatology
studies.
Name: Penny Storrs
Base: Salford Royal, Hope Hospital
Role: Penny is employed part-time to work on a variety of portfolio
studies at Salford Royal. She will be working on studies for Dr Ariane
Herrick, Dr Terry O’Neill and Professor Anthony Jones.
We would like to take this opportunity to wish the nurses well in their
posts!!

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Musculoskeletal Research Practitioner Workshop
Wrightington, 29th March 2011
On Tuesday 29th March Greater Manchester and Cheshire & Merseyside
CLRNs ran a combined workshop aimed at Musculoskeletal research
practitioners. The workshop was held at Wrightington Hospital Conference
Centre and focussed around 3 main topics:
∗
∗
∗
Recruitment to trials
MHRA inspections: how to prepare
Intention to treat analysis and patient retention
We would like to thank Ella Bacabac and Angie Miller (research nurses from
Cheshire & Merseyside) along with Professor Deborah Symmons, for
running these workshops.
Thank you also to Professor John Goodacre (Musculoskeletal Lead, Cumbria
& Lancashire CLRN) for his introductory lecture entitled “Training and
development of the NIHR workforce of the future”.
The half-day event was well-attended by people from all 3 CLRNs and
provided an opportunity for research practitioners, working in the same
area of research to meet.
There was also an opportunity to meet some of the study co-ordinators
and view the study material that was on display.
The afternoon ended with a short GCP quiz co-ordinated by Hawys Williams
(TRACE RA trial manager) and the winning groups went home with some
lovely chocolatey goods!
The afternoon was a success and a feedback survey was sent to those who
attended the workshop for their comments. You can view the results of the
survey on the next page.

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Workshop survey feedback
1. To which CLRN are you affiliated Response %
Greater Manchester 66.7%
Cheshire & Merseyside 8.3%
Cumbria & Lancashire 25%
2. Please select the option which best describes your role within
musculoskeletal research
Research nurse 41.7%
Physiotherapist 16.7%
Trial co-ordinator 25%
Doctor 0%
Occupational therapist 0%
other 16%
3. How interesting and informative did you find the opening presentation
“Training and development of the NIHR workforce of
the future”
Very interesting 16.7%
Interesting 83.3%
No new information provided 0%
Not relevant to me 0%
4. How useful and informative did you find each of the workshop
sessions (scored 1-5 with 1 being the lowest)
Recruitment to trials 33.3% (5)
33.3% (3)
MHRA inspections – how to prepare 33.3% (5)
41.7% (3)
8.3% (2)
Intention to treat analysis and patient retention 41.7% (5)
25.0% (4)
33.3% (3)
5. Was the workshop a good networking opportunity
Yes 83.3%
No 8.3%
Not sure 8.3%
6. Were there sufficient opportunities to ask questions
Yes 100%
No 0%
Not sure 0%
7. Would you be interested in attending similar workshops/
events in the future
Yes 83.3%
No 8.3%
Maybe 8.3%
8. Any feedback or suggestions for future workshops:
Longer time spent on each workshop
Better introduction time so all attendees know who each other are

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And finally………
Donna Taylor-Fesler will be leaving Stockport NHS Foundation Trust and
continuing in the role of Administrator for the Musculoskeletal Local
Speciality Group at the University of Manchester from 1st May 2011. From
end of April 2011 the e-mail address:
musculoskeletal@stockport.nhs.uk will no longer be in use.
Donna’s new e-mail address is: musculoskeletal@manchester.ac.uk
Musculoskeletal local speciality group contacts:
Call us:
e-mail us:
Professor Deborah Symmons 0161 275 5044
deborah.symmons@manchester.ac.uk
Donna Taylor-Fesler 0161 275 3229 musculoskeletal@manchester.ac.uk
Lorraine Lock 0161 275 3229 Lorraine.lock@manchester.ac.uk
Jane McConniffe 0161 275 3229 jane.mcconniffe@manchester.ac.uk
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