Condition category
Musculoskeletal Diseases
Date applied
05/09/2017
Date assigned
11/09/2017
Last edited
22/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cystic Fibrosis is a condition that causes the lungs and digestive system clogged with mucus. Cystic Fibrosis associated arthropathy (CFA) is a condition thought to affect up to 10% of the CF population. It causes joint pain and swelling which is often intermittent, but which may become long-lasting. The aim of this study is to review patients with CF and inflammatory musculoskeletal symptoms with the aim of better understanding the phenotype and range of this condition. This will help to identify patients who need further investigation and treatment for joint symptoms. It will also aid future studies considering treatment options for this condition.

Who can participate?
Patients aged 16 or over who have CF, and who report joint swelling, morning stiffness, or impact on activities of daily living due to joint symptoms as well as patients with CF who do not have joint issues.

What does the study involve?
Participants are asked to attend an appointment for a clinical history and examination to be completed, and an ultrasound of their joints. Following this review, participants are asked to reattend only if their joint symptoms flare. They are asked to contact the CF unit should this occur. A follow-up telephone call is used at the end of the study period to confirm flare patterns. Participants with CF without joint disease have one visit combined with a routine clinic visit to include blood tests and ultrasound along with a clinical examination. They will also have a telephone call at the end of the study to ensure that they have not developed joint symptoms in the intervening time period.

What are the possible benefits and risks of participating?
Participants may benefit from better identification for patients seen with inflammatory joint disease so that treatment options may be discussed (in current form, evidence for these is extrapolated from other rheumatic diseases). In some cases, identification that pain is not currently associated with inflammation in the joint, and advice can be given on this basis and other associations with pain looked for. There are risks of bruising and minor discomfort for blood tests. There is a small risk of radiation with the ultrasounds associated with x-rays of symptomatic joints - these will only be carried out if they would be done so in routine clinical practice.

Where is the study run from?
1. Manchester Adult Cystic Fibrosis Centre (UK)
2. Leeds Adult Cystic Fibrosis Centre (UK)

When is the study starting and how long is it expected to run for?
April 2017 to November 2018

Who is funding the study?
1. CF trust (UK)
2. Manchester Adult CF unit (UK)
3. Leeds University (UK)

Who is the main contact?
Dr Elizabeth Clarke
elizabeth.clarke@manchester.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Elizabeth Clarke

ORCID ID

http://orcid.org/0000-0002-6703-6281

Contact details

Manchester Adult Cystic Fibrosis Unit
University Hospital South Manchester
Manchester
M23 9LT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

awaited

Study information

Scientific title

Identifying a Phenotype in Cystic Fibrosis Associated Arthritis

Acronym

PAC

Study hypothesis

This study aims to review patients with CF and inflammatory musculoskeletal symptoms with the aim of better understanding the phenotype and range of this condition.

Ethics approval

Not provided at time of registration.

Study design

Observational cohort with control arm

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

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

Condition

Cystic Fibrosis Associated Arthropathy

Intervention

This is an observational study looking at cystic fibrosis associated arthropathy patterns of disease, to include clinical history and examination, serology, and ultrasound.

Patients with CF who have inflammatory-sounding joint symptoms are recruited to this observational cohort study. Participants attend a baseline visit in which they are seen by the clinical fellow to gain background medical information, a clinical examination, collect blood tests and complete an ultrasound of joints when they are not flaring. Xrays of joints are requested only for patients in whom it would be clinically indicated (unremitting or longstanding pain and swelling). Joint aspiration is carried out only where there is a significant effusion, in which case it would be clinically indicated. Investigation with blood tests includes inflammatory markers; urate (for gout); rheumatoid factor and anti CCP (associated with rheumatoid arthritis) and HLA-B27 (associated with seronegative spondyloarthropathies). Participants are then seen as and when their joint symptoms flare in order to characterise the patterns of events and to gain clinical examination data, ultrasound imaging and bloods to gain a better picture of the disease. A telephone call at the end of the study is used to confirm patterns of disease flare over the study period.

25 patients with CF who do not have joint disease act as healthy control participants. These patients will have one visit combined with a routine clinic visit to include a medical history and clinical examination, blood tests and ultrasound.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Patterns of disease identified by clinical manifestation, ultrasound findings and serology over a 9 month follow-up.

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

01/04/2017

Overall trial end date

01/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Cystic Fibrosis
2. Peripheral joint disease including current or previous joint swelling affecting activities of daily living
3. Aged over 16
4. Attendance at either the Manchester or Leeds CF centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

1. Joint problems that when reviewed sound primarily biomechanical or have another non-inflammatory cause
2. Under 16 years

Recruitment start date

14/10/2017

Recruitment end date

14/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Manchester Adult Cystic Fibrosis Unit
University Hospitals South Manchester Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Leeds Cystic Fibrosis Centre
Gledhow Wing Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University Hospital South Manchester

Sponsor details

Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 161 998 7070
sian.hanison@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Cystic Fibrosis Trust

Alternative name(s)

CF

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Manchester Adult Cystic Fibrosis Unit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Leeds University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination of results to participants and the CF community via our research newsletter and our unit facebook and twitter pages when possible. Planned publication in a high-impact peer reviewed journal 01/02/2020. A copy of the protocol will be available following review by the ethics committee.

IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available due to the raw data will be held separately from any patient identifiers for 5 years by the trust (UHSM) who are our sponsor. Requests for access would be via the trust but generally the information has been gather for a specific reason (this study) and could not therefore be used for another purpose.

Intention to publish date

01/02/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/09/2017: Internal review.