Table 2.
Currently planned or ongoing clinical trials in ANCA-associated vasculitis
| Name | Treatment Studied | Status | Patients | Primary Outcomes | Clinical Trial no. |
|---|---|---|---|---|---|
| ABROGATE | Abatacept (CTLA-4 immunoglobulin) | Not yet recruiting | GPA | Treatment failure after 12 months of treatment | NCT02108860 |
| Evaluate the efficacy of achieving glucocorticoid-free remission in patients with relapsing non-severe GPA | |||||
| ALEVIATE | Alemtuzumab (monoclonal anti-CD52) | Unknown | GPA and MPA | Complete or partial remission after 6 months; adverse event | NCT01405807 |
| Evaluating whether alemtuzumab induces sustained remission in refractory patients | |||||
| BIANCA-SC | Blisibimod (selective antagonist of BAFF) | Not yet recruiting | GPA and MPA | Induction of clinical remission | NCT01598857 |
| Evaluate efficacy of blisibimod when taken with methotrexate to induce remission | |||||
| BREVAS | Belimumab (human monoclonal anti-BAFF) | Recruiting | GPA and MPA | Time to first relapse | NCT01663623 |
| Assessing efficacy of belimumab in maintenance of remission following a standard induction regimen | |||||
| CLASSIC | CCX168 (C5a inhibitor) | Recruiting | GPA and MPA | Safety and efficacy of two-dose regimen | NCT02222155 |
| Studying the safety and efficacy of CCX168 for induction therapy (low versus high dose) with conventional therapy | |||||
| CLEAR | CCX168 (C5a inhibitor) | Recruiting | GPA and MPA | Safety (adverse events) and efficacy (BVAS) | NCT01363388 |
| Studying the safety and efficacy of CCX168 versus placebo for induction therapy on a background of conventional therapy | |||||
| LoVAS | Rituximab with glucocorticoids | Recruiting | GPA and MPA | Remission induction | NCT02198248 |
| Comparing rituximab with low-dose glucocorticoids versus rituximab with high-dose glucocorticoids | |||||
| MAINRITSAN-2 | Rituximab (two strategies) | Active, not recruiting | GPA and MPA | Number of minor and major relapses | NCT01731561 |
| Assess efficacy of a rituximab regimen based on rate of ANCA and CD19 lymphocytes for maintenance of remission | |||||
| PEXIVAS | Plasma exchange | Recruiting | GPA and MPA | All-cause mortality; end-stage renal disease | NCT00987389 |
| Determining whether plasma exchange with immunosuppressive therapy are effective in reducing death and ESRD | |||||
| RAVELOS | Rituximab (chimeric monoclonal anti-CD20) | Recruiting by invitation | GPA and MPA | Long-term safety and effects of rituximab | NCT01586858 |
| Following the patients included in the RAVE study to study long-term outcome after rituximab treatment | |||||
| RITAZAREM | Rituximab | Recruiting | GPA and MPA | Time to first relapse | NCT01697267 |
| Evaluating whether repeated rituximab will maintain remission | |||||
| SCOUT | Glucocorticoids and rituximab | Recruiting | GPA and MPA | Complete remission | NCT02169219 |
| Studying whether an 8-week course of glucocorticoids with rituximab is effective as remission induction | |||||
| TAPIR | Glucocorticoids | Recruiting | GPA | Increase of the glucocorticoid dose for disease relapse | NCT01933724–NCT01940094 |
| Evaluating the effects of low-dose glucocorticoids (5 mg/day) versus stopping completely in GPA in remission | |||||