Contact information
Type
Scientific
Primary contact
Dr Bridget Griffiths
ORCID ID
Contact details
Musculoskeletal Unit
Level 2 Freeman Hospitals
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
+44 (0)191 284 3111
bridget.griffiths@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0535
Study information
Scientific title
Acronym
CYAZ
Study hypothesis
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
Not provided at time of registration
Study design
Multicentre randomised open label active controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Added 20/01/10:
Absolute mean change in prednisolone
Secondary outcome measures
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
Overall trial start date
01/06/1998
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
89 (added 20/01/10)
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/1998
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Musculoskeletal Unit
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Organisation
Arthritis Research Campaign (ARC) (UK)
Sponsor details
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Arthritis Research Campaign (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20081225
Publication citations
-
Results
Griffiths B, Emery P, Ryan V, Isenberg D, Akil M, Thompson R, Maddison P, Griffiths ID, Lorenzi A, Miles S, Situnayake D, Teh LS, Plant M, Hallengren C, Nived O, Sturfelt G, Chakravarty K, Tait T, Gordon C, The BILAG multi-centre open randomized controlled trial comparing ciclosporin vs azathioprine in patients with severe SLE., Rheumatology (Oxford), 2010, 49, 4, 723-732, doi: 10.1093/rheumatology/kep396.