Condition category
Musculoskeletal Diseases
Date applied
18/07/2002
Date assigned
18/07/2002
Last edited
20/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.arc.org.uk

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

  1. 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.

Additional files

Editorial Notes