Low-dose Glucocorticoid Vasculitis Induction Study

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT02198248
• Date of registration: 18/07/2014
• Prospective Registration: Yes
• Primary sponsor: Chiba University
• Public title: Low-dose Glucocorticoid Vasculitis Induction Study LoVAS
• Scientific title: Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial
• Date of first enrolment: October 2014
• Target sample size: 140
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02198248
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Japan

Contacts

• Name: Hiroshi Nakajima, M.D., Ph.D
• Affiliation: Chiba University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Provision of written informed consent by a patient or a surrogate decision maker

2. Age=>20 years

3. New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with
polyangiitis, microscopic polyangiitis or renal limited ANCA-associated vasculitis)
consistent with the 2012 Chapel Hill consensus definitions

4. Positive test by ELISA for proteinase 3-ANCA or myeloperoxidase-ANCA

Exclusion Criteria:

1. Prior treatment for ANCA-associated vasculitis before trial entry

2. ANCA-associated vasculitis related glomerulonephritis (eGFR<15ml/min) or alveolar
hemorrhage (oxygen inhalation >2L/min)

3. Presence of another multisystem autoimmune disease

4. Known infection with HIV; a past or current history of hepatitis B virus or hepatitis
C virus infection

5. Desire to bear children, pregnancy or lactating

6. History of malignancy within the past 5 years or any evidence of persistent malignancy

7. Ongoing or recent (last 1 year) evidence of active tuberculosis

8. Severe allergy or anaphylaxis to monoclonal antibody therapy

9. Any concomitant condition anticipated to likely require oral systemic glucocorticoids,
immunosuppressants, biologics, plasma exchange or IVIg

10. Any biological B cell depleting agent (such as rituximab or belimumab) within the past
6 months

11. Other conditions, in the investigator's opinion, inappropriate for the trial entry



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wegener Granulomatosis

Microscopic Polyangiitis

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Intervention(s)

Drug: Glucocorticoids

Drug: Rituximab

Primary Outcome(s)

Proportion of the patients achieving remission [Time Frame: 6 months]

Secondary Outcome(s)

Proportion of the patients with new onset insomnia [Time Frame: at 6 and 24 months]

Accumulative dose of glucocorticoids [Time Frame: assessed at 6 and 24 months]

Overall survival, disease free survival, time to end-stage renal disease, time to the first serious adverse event [Time Frame: 0-24 months]

Patient global assessment (visualised analogue scale) [Time Frame: assessed at 0, 6, 12, 18 and 24 months]

Time to remission [Time Frame: assessed at 1, 2, 4 and 6 months]

Proportion of the patients with new onset bone fracture, bone density [Time Frame: at 6 and 24 months]

Short-Form 36 (SF-36) [Time Frame: assessed at 0, 6, 12, 18 and 24 months]

Proportions of the patients with new onset hyperlipidemia [Time Frame: at 6 and 24 months]

Proportions of major relapse [Time Frame: at 24 months]

Number of infections, proportions of the patients with infection [Time Frame: at 6 and 24 months]

Numbers of events of adverse events/serious adverse events, proportions of the patients with adverse events/serious adverse events [Time Frame: at 6 and 24 months]

Proportions of the patients with new onset diabetes mellitus [Time Frame: at 6 and 24 months]

Proportions of the patients with new onset hypertension [Time Frame: at 6 and 24 months]

Birmingham Vasculitis Activity Score (BVAS) version 3 [Time Frame: assessed at 0, 1, 2, 4, 6, 9, 12, 18 and 24 months]

Proportions of death, relapse, end-stage renal disease and the composite of these [Time Frame: at 6 and 24 months]

Proportions of patients achieving remission and discontinuance of glucocorticoids [Time Frame: at 6 and 24 months]

Vasculitis Damage Index (VDI) [Time Frame: assessed at 0, 6, 12, 18 and 24 months]

Secondary ID(s)

G25051

UMIN000014222

Source(s) of Monetary Support

Please refer to primary and secondary sponsors