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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35919612

Enrollment

Registered

2002-07-18

Start date

1998-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus (SLE) Musculoskeletal Diseases Systemic lupus erythematosus

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Added 20/01/10: Absolute mean change in prednisolone	—

Secondary

Measure	Time frame
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 1, 2026