Evaluation of the optimal duration of immunosuppressive treatment after induction of remission, in patients with ANCA vasculitis

Randomised controlled trial comparing relapse rate between standard (18 to 24 months) and prolonged (48 months) immunosuppression with azathioprine and prednisolone, in patients in the remission phase of ANCA vasculitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13739474

Enrollment

116

Registered

2017-01-10

Start date

1998-09-01

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

ANCA-associated vasculitis Circulatory System ANCA-associated vasculitis

Interventions

Patients with ANCA vasculitis in stable remission are included 18 to 24 months after initiation of immunosuppressive therapy. Patients are randomised in a 1:1 ratio to either withdraw from immunosuppr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of MPA, GPA or renal-limited vasculitis 2. Renal involvement and/or other threatened loss of function of a vital organ (lung, brain, eye, motor nerve, or gut); and ANCA positivity (ANCA-negative patients were eligible for enrollment in the study only when there was histologic confirmation of pauci-immune vasculitis) 3. Remission-induction therapy with cyclophosphamide and prednisolone for at least 3 months, with or without plasma exchanges 4. Stable remission on azathioprine/prednisolone 5. Aged 18 years and over

Exclusion criteria

Exclusion criteria: 1. Age under 18 years 2. Pregnancy 3. Previous malignancy 4. Known HIV infection 5. Previous life-threatening relapse 6. End-stage renal disease (ESRD) at inclusion and allergy to study medications. Patients not in stable remission for at least six months at 18 months after commencement of therapy and patients who had discontinued azathioprine and/or prednisolone are excluded from the study.

Design outcomes

Primary

Measure	Time frame
Rate of vasculitis relapse is measured using the Birmingham Vasculitis Activity Score (BVAS) continuously from baseline to 30 months.	—

Secondary

Measure	Time frame
1. Incidence of major and minor relapse is measured using the Birmingham Vasculitis Activity Score (BVAS) continuously from baseline to 30 months 2. Mortality rate is measured continuously from baseline to 30 months 3. Adverse events of therapy are observed continuously from baseline to 30 months 4. Cumulative damage is assessed using the Vasculitis Damage Index (VDI) from baseline to 30 months 5. Renal function is assessed by measuring estimated Glomerular Filtration Rate (eGFR) from baseline to 30 months 6. Incidence of end-stage renal disease (ESRD) is monitored from baseline to 30 months 7. ANCA status	—

Measure

Time frame

1. Incidence of major and minor relapse is measured using the Birmingham Vasculitis Activity Score (BVAS) continuously from baseline to 30 months 2. Mortality rate is measured continuously from baseline to 30 months 3. Adverse events of therapy are observed continuously from baseline to 30 months 4. Cumulative damage is assessed using the Vasculitis Damage Index (VDI) from baseline to 30 months 5. Renal function is assessed by measuring estimated Glomerular Filtration Rate (eGFR) from baseline to 30 months 6. Incidence of end-stage renal disease (ESRD) is monitored from baseline to 30 months 7. ANCA status

—

Countries

Czech Republic, Finland, France, Germany, Italy, Lithuania, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026