Maintenance therapy in patients with severe Systemic lupus erythematosus (SLE): The BILAG multi-centre open randomised controlled trial comparing cyclosporin A and azathioprine

ISRCTN	ISRCTN35919612
DOI	https://doi.org/10.1186/ISRCTN35919612
Protocol serial number	G0535
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Bridget Griffiths
Scientific

Musculoskeletal Unit
Level 2 Freeman Hospitals
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Phone	+44 (0)191 284 3111
Email	bridget.griffiths@ncl.ac.uk

Primary study design	Interventional
Study design	Multicentre randomised open label active controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CYAZ
Study objectives	Added 20/01/10: To determine whether low-dose ciclosporin was a more effective corticosteroid-sparing agent than AZA in patients with SLE. Please note that as of 20/01/10 this record has been updated. All updates can be found in the relevant field with the above update date. This information was obtained from the publication below PMID: 20081225.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Systemic lupus erythematosus (SLE)
Intervention	1. Steroids tapered accordingly to protocol 2. Randomised to azathioprine or cyclosporin A 3. Dose increased according to body weight and tolerability Added 20/01/10: Duration of intervention was 12 months
Intervention type	Other
Primary outcome measure(s)	Added 20/01/10: Absolute mean change in prednisolone
Key secondary outcome measure(s)	Added 20/01/10: 1. Change in disease activity (classic British Isles Lupus Assessment Group [BILAG] index) 2. Number of flares 3. Development of new damage 4. Change in quality of life
Completion date	31/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	89
Key inclusion criteria	1. American Rheumatism Association (ARA) criteria for SLE 2. New corticosteroid sparing agent required 3. Patient on 15 mg or more of prednisolone for at least 4 weeks
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/1998
Date of final enrolment	31/12/2004

Musculoskeletal Unit

Newcastle upon Tyne
NE7 7DN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No