ARA Database

Participants: 'Expression of Interest' form
Rheumatologists: 'Permission to Contact' form
Adverse Event Reporting for ARAD patients taking bDMARDs (please complete and fax toll free to: 1800 022 730)
Participant Newsletter - September 2009
ARAD 6-monthly report - October 2009
ARAD access for external researchers: Access Policy and Expression of Interest form
Participant Brochure
Publications
Reply Paid Labels

Australian Rheumatology Association Database
A R A D

Currently funded by: NHMRC Enabling Grant
Supported by:
Monash University
Cabrini Health

with additional funding through Educational Grants to the ARA from:

Abbott Australasia Pty Ltd
Roche Products Pty Ltd
Wyeth Australia Pty Ltd

Previous educational grants were provided to the ARA by:
Amgen Australia Pty Ltd
Aventis
Schering Plough

DATABASE UPDATE : December 2009

As of 1st January 2009 there are 4037 participants enrolled across Australia from 222 participating rheumatologists. The table below summarises the enrolment characteristics of the ARAD cohort.

	Diagnosis
Current bDMARD	RA	AS	PsA	JCA	AOSD
abatacept	76	1	0	1	0
rituximab	179	0	1	0	0
adalimumab	862	188	171	1	0
anakinra	4	0	0	5	1
etanercept	1043	225	125	95	0
infliximab	98	189	33	4	0
tocilizumab	3	0	0	0	0
not receiving therapy	249	18	24	10	0
control (phase4)	320	16	48	47	0
*Total*	2834	637	402	163	1

Total = 4037*
* Some patients are currently missing diagnosis

Received PTC but
awaiting patient consent

284

102

1. Direct patient recruitment is continuing. Patients wanting more information are being guided to the 'Patients: Expression of Interest' form on the ARAD website (see above) and/or to the State Co-ordinators. This DOES NOT replace rheumatologists referring patients to ARAD.

2. Please note that the 'Access Policy' and 'Expression of Interest Form' for external researchers to access de-identified ARAD data are available to download from this site (see above).

3.The most recent ARAD 6 monthly aggregate report for rheumatologists is available at: 6-monthly report

Rheumatologists are urged to continue enrolling CONTROL patients (i.e. patients with inflammatory arthritis who have not received biological therapy). To enrol a CONTROL patient, simply complete the "Rheumatologists: Permission to Contact" form in the same manner as non-control patients.

We would like to thank all participating rheumatologists for their continuing support of ARAD.

ARAD PROJECT TEAM
Investigators
Professor Rachelle Buchbinder
Associate Professor Lyn March
Professor Marissa Lassere
Associate Professor Christopher Reid

Project Manager
Maree Williams
e: Maree.Williams@med.monash.edu.au
Tel: 03 9508 1137
Fax: 03 9508 1653

State coordinators
QLD, WA, NT & TAS
Lyndall Henderson
e: lyndallh@med.usyd.edu.au
Tel: 02 9926 8579
Fax: 02 9906 1859

NSW & ACT
Joy Rappo
Tel: 02 9113 2982
Fax: 02 9588 1156

VIC & SA
Joan McPhee
e: Joan.McPhee@med.monash.edu.au
Tel:(03) 9508 1137
Fax: 03 9508 1653

Data Centre Staff
Molly Bond
Vibhasha Chand
Nino Hay
Fax: 1800 022 730
http://www.ccretherapeutics.org.au/

(Member Access Only)
Participating Members Information
Includes:
- Participating Members List
- Adverse Event Reporting for ARAD patients taking bDMARDs
- Spreadsheet to track patients taking bDMARDs

What is ARAD?

It is a national Australian database which collects important health information from individuals with inflammatory arthritis including:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Juvenile arthritis
- Psoriatic arthritis
The aim of ARAD is to determine the short and long term effectiveness and safety of new biological drugs, such as Enbrel, Remicade, Humira, Kineret, MabThera and Orencia, used to treat inflammatory arthritis conditions.
ARAD collects information from patients every 6 months via questionnaires. Questions about medical history, medication history, responses to medication, physical functioning and quality of life are asked.
Patients and rheumatologists across Australia contribute to ARAD.

Adverse Event Reporting for ARAD patients
If a patient participating in ARAD develops an adverse event you may notify us by completing the form at the link above and faxing it to us (toll free 1800 022 730). In particular, these may be adverse events that are definitely or possibly related to bDMARD. We are however interested in adverse events in all ARAD patients.

We will then send a copy of the form to the Australian Drug Reaction Advisory Committee (ADRAC) unless you advise us not to. This means that you do not need to complete a blue ADRAC form for these patients.

The adverse event information that you provide will be stored securely by the ARAD Data Management Centre and will be completely confidential.

ARAD access for external researchers

ARAD is funded in part by an NHMRC Enabling Grant This NHMRC scheme supports facilities where there is a national need for the facility and provides all Australian researchers with access to the facility. Guidelines about access to ARAD for Australian researchers are contained in the ARAD Access Policy document. Researchers interested in accessing ARAD should read the document carefully and submit an Expression of Interest form, along with other materials described in the documents. Other sources of financial support for ARAD come from the ARA, Monash University and pharmaceutical companies (through educational grants).

The benefits of participating and supporting ARAD

ARAD provides a valuable resource for clinicians and researchers of this chronic disease and provides a quality assurance activity for rheumatologists
ARAD can monitor patient outcomes and any adverse events that may be experienced
Monitor adverse events
Regular reports are provided to participating rheumatologists with the progress of their own patients as well as comparing their patients to the ARAD population. ARAD 6-monthly report - May 2009
Regular newsletters are provided to participants updating them on ARAD and providing them with information on arthritis
With the enrolment of a control group in the future, comparisons can be made between patients on biological therapies and those not on biologicals

Patients - what do you need to do?

To enrol, you can ask your Rheumatologist to fill in a 'Permission to Contact' form. Alternatively, if you would like to register your interest directly, a Participants: "Expression of Interest" form can be downloaded from the ARAD website (see above).

Then, fax the Participants: "Expression of Interest" form (toll free) to: 1800 022 730.

Your ARAD State Co-ordinator will then:
1. Send you an ARAD pack containing a patient information and consent form, questionnaire and a reply paid envelope
2. Contact you to explain the project and what your involvement would be.

Participation involves completing a written postal questionnaire survey every 6 months. Each questionnaire should take about 30 minutes to complete.

ARAD collects information about your arthritis and health, the medications you take, your quality of life and information from state and federal health registries.

There are NO blood or physical tests in ARAD.

We encourage you to discuss your participation with your Rheumatologist.

All patient information is de-identified and stored in a password protected database, accessible only by ARAD staff.

Rheumatologists - what do you need to do?

When preparing the application form for the biologic medication:

Introduce ARAD Participant Brochure and ask patient to sign the 'Permission to Contact' form.
Advise patient that ARAD will contact them to discuss the registry in further detail.
Complete the Rheumatologist box on the 'Permission to Contact' form and ask the patient to complete and sign the relevant section.

Then fax the 'Permission to Contact' form to ARAD Data Management Centre on toll free:
1800 022 730

The ARAD project team then:

Maintains regular contact with the patient and collects data from them at 6 monthly intervals
Provides feedback to the rheumatologist on their patient's progress

PARTICIPANT NEWSLETTER ARCHIVE
July 2009
January 2009
July 2008
January 2008
July 2007
January 2007
July 2006
August 2005