Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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Trial registered on ANZCTR


Registration number
ACTRN12611000877987
Ethics application status
Not yet submitted
Date submitted
15/08/2011
Date registered
17/08/2011
Date last updated
17/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Mannose-binding lectin (MBL) deficiency is more frequent in rheumatoid arthritis patients with coexistant bronchiectasis than in patients with rheumatoid arthritis alone or bronchiectasis alone.
Scientific title
Are patients who have co-existant Rheumatoid arthritis and bronchiectasis more likely to be deficient in mannose-binding lectin (MBL) compared with patients with rheumatoid arthritis alone or bronchiectasis alone?
Secondary ID [1] 262834 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 270559 0
Bronchiectasis 270560 0
Condition category
Condition code
Inflammatory and Immune System 270721 270721 0 0
Rheumatoid arthritis
Respiratory 270722 270722 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
With the permission of the heads of department of both Rheumatology and Respiratory medicine at Fremantle Hospital, an audit will take place of patients attending the outpatient clinic of both of these departments between 2006 and 2010. At the same time an audit of patients attending the private rooms of one of the investigators will also be carried out. This audit will identify subjects who have had a serum MBL level measured at some part of their disease investigation and who have a diagnosis of rheumatoid arthritis alone, bronchiectasis alone, or coexisting RA and bronchiectasis. Once the patients have been identified, data including age, sex and details of diagnosis will be collated from the existing patient record. The audit and data collection will take place over a 3 month period commencing September 2011.
Intervention code [1] 269187 0
Not applicable
Comparator / control treatment
Serum MBL levels of subjects suffering both RA and Bronchiectasis will be compared with serum MBL levels of subjects suffering RA alone and subjects suffering bronchiectasis alone.
Control group
Historical

Outcomes
Primary outcome [1] 269429 0
Frequency of MBL deficiency in identified subjects.
Timepoint [1] 269429 0
End of study period
Secondary outcome [1] 287622 0
nil
Timepoint [1] 287622 0
nil

Eligibility
Key inclusion criteria
Diagnosis of RA according to American College of Rheumatology criteria.
Diagnosis of Bronchiectasis made by a Consultant Respiratory physician
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269658 0
Self funded/Unfunded
Name [1] 269658 0
N/A
Country [1] 269658 0
Australia
Primary sponsor type
Individual
Name
Krista Makin
Address
Fremantle Hospital
Alma St
Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 266696 0
Individual
Name [1] 266696 0
Dr Graeme Carroll
Address [1] 266696 0
Fremantle Hospital
Alma St
Fremantle WA 6160
Country [1] 266696 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269606 0
South Metropolitan Area Health Service HREC
Ethics committee address [1] 269606 0
Fremantle Hospital
Alma St
Fremantle Wa 6160
Ethics committee country [1] 269606 0
Australia
Date submitted for ethics approval [1] 269606 0
23/08/2011
Approval date [1] 269606 0
Ethics approval number [1] 269606 0

Summary
Brief summary
There is a well established association between rheumatoid arthritis (RA) and bronchiectasis. It has been observed that patients who suffer RA are between 10 and 30 times more likely to develop bronchiectasis. The aetiology of this association is unknown. Mannose-binding lectin (MBL) is a component of the immune system which is active in fighting infection. It is thought that a deficiency in MBL may predispose individuals to infection especially if there is coexisting immunodeficiency. This study seeks to find an association between MBL deficiency and the development of bronchiectasis in patients with RA as a means to providing insight into the association between the two diseases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33019 0
Address 33019 0
Country 33019 0
Phone 33019 0
Fax 33019 0
Email 33019 0
Contact person for public queries
Name 16266 0
Dr Krista Makin
Address 16266 0
Fremantle Hospital
Alma St
Fremantle WA 6160
Country 16266 0
Australia
Phone 16266 0
+61 8 9431 3333
Fax 16266 0
Email 16266 0
[email protected]
Contact person for scientific queries
Name 7194 0
Dr Krista Makin
Address 7194 0
Fremantle Hospital
Alma St
Fremantle WA 6160
Country 7194 0
Australia
Phone 7194 0
+61 8 9431 3333
Fax 7194 0
Email 7194 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.