Who Is Eligible for Vasculitis Clinical Trials?
Vasculitis trials span several distinct diseases, each with separate eligibility criteria. ANCA-associated vasculitis (AAV) trials โ covering GPA, MPA, and EGPA โ typically require a confirmed diagnosis per 2022 ACR/EULAR criteria and active disease defined by a Birmingham Vasculitis Activity Score (BVAS) above a threshold. GCA trials require biopsy or imaging confirmation and active disease or steroid-dependence. Many vasculitis trials recruit specifically for remission maintenance โ patients who have achieved induction remission but need long-term therapy to stay in remission.
- Confirmed vasculitis diagnosis per 2022 ACR/EULAR criteria (AAV, GCA, TAK)
- Active disease defined by BVAS for AAV, or imaging/PET for GCA and TAK
- ANCA positivity (PR3 or MPO) for most AAV trials โ though ANCA-negative GPA can qualify
- Remission-maintenance trials: patients who achieved induction and need long-term therapy
- GCA trials often recruit steroid-dependent patients specifically
What Treatments Are Being Tested?
| Drug Class | How It Works | Who It Is For |
|---|---|---|
| Avacopan (complement C5aR inhibitor) | FDA-approved for ANCA vasculitis โ new trials testing in maintenance and combination | GPA/MPA, steroid-sparing protocols |
| CD20 depletors (new generation) | Next-gen anti-CD20 agents for AAV remission induction and maintenance | Active GPA/MPA, PR3+ patients |
| IL-6 inhibitors | Block IL-6 driving GCA inflammation โ tocilizumab already approved, new agents in trials | GCA and TAK, steroid-dependent disease |
| IL-12/23 inhibitors | Emerging data in EGPA and eosinophilic vasculitis | EGPA with eosinophilic involvement |
| JAK inhibitors | Oral agents for GCA and TAK โ potentially replacing or reducing steroids | GCA and TAK, steroid-sparing |
What to Expect as a Trial Participant
Vasculitis trials vary by disease type. AAV trials use BVAS to measure activity. GCA trials use symptom scores and imaging (PET/CT or MRI). Most aim for steroid-sparing as a key endpoint alongside disease control.
- Screening: BVAS or equivalent disease activity score, ANCA testing, imaging (PET/CT or MRI angiography for GCA/TAK), labs
- Baseline: Randomization โ most are double-blind
- Treatment visits: Every 4-12 weeks depending on drug and disease
- Steroid taper: Many trials include a structured steroid taper protocol as part of the study design
- Compensation: Most sites pay $100-$300 per visit due to complexity
Frequently Asked Questions
Other Rheumatology Trials
Trial data sourced live from ClinicalTrials.gov. Content reviewed by Mahiar Rabie, MS, MD. This page is for informational purposes only and does not constitute medical advice. Eligibility for any specific trial must be confirmed with the trial coordinator.