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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
ClinicalTrials.gov identifier
Public title Maintenance therapy in patients with severe Systemic lupus erythematosus (SLE): The BILAG multi-centre open randomised controlled trial comparing cyclosporin A and azathioprine
Scientific title
Acronym CYAZ
Serial number at source G0535
Study hypothesis Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Systemic lupus erythematosus (SLE)
Participants - 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
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/06/1998
Anticipated end date 31/12/2004
Status of trial Completed
Patient information material
Target number of participants Not provided at time of registration
Interventions 1. Steroids tapered accordingly to protocol
2. Randomised to azathioprine or cyclosporin A
3. Dose increased according to body weight and tolerability
Primary outcome measure(s) Not provided at time of registration
Secondary outcome measure(s) Not provided at time of registration
Sources of funding Arthritis Research Campaign (UK)
Trial website
Publications
Contact name Dr  Bridget  Griffiths
  Address Musculoskeletal Unit
Level 2 Freeman Hospitals
High Heaton
  City/town Newcastle upon Tyne
  Zip/Postcode NE7 7DN
  Country United Kingdom
  Tel +44 (0)191 284 3111
  Email bridget.griffiths@ncl.ac.uk
Sponsor Arthritis Research Campaign (ARC) (UK)
  Address Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
  City/town Derbyshire
  Zip/Postcode S41 7TD
  Country United Kingdom
  Email info@arc.org.uk
  Sponsor website: http://www.arc.org.uk
Date applied 18/07/2002
Last edited 28/04/2008
Date ISRCTN assigned 18/07/2002
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