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 |
| Secondary identifying numbers | G0535 |
- Submission date
- 18/07/2002
- Registration date
- 18/07/2002
- Last edited
- 20/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bridget Griffiths
Scientific
Scientific
Musculoskeletal Unit
Level 2 Freeman Hospitals
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
| Phone | +44 (0)191 284 3111 |
|---|---|
| bridget.griffiths@ncl.ac.uk |
Study information
| Study design | Multicentre randomised open label active controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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 study start date | 01/06/1998 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 89 (added 20/01/10) |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Musculoskeletal Unit
Newcastle upon Tyne
NE7 7DN
United Kingdom
NE7 7DN
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
