The Vasculitis Foundation encourages patients with vasculitis to participate in research when possible. Some studies are clinically based, others are being conducted by marketing research companies to help industry better understand disease activity.

A complete list of research studies can be found at ClinicalTrials.gov.  Once you are on the page, please enter “vasculitis” in the search box or your own individual form of vasculitis for studies specifically targeted towards patients like you.

Recruiting: A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA)

This study consists of two periods. The objective of Period 1 is to evaluate the efficacy of upadacitinib in combination with a 26-week corticosteroid (CS) taper regimen compared to placebo in combination with a 52-week CS taper regimen, as measured by the proportion of participants in sustained remission at Week 52, and to assess the safety and tolerability of upadacitinib in participants with giant cell arteritis (GCA). The objective of period 2 is to evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved remission in Period 1.

Click here to learn more about this study.
ClinicalTrials.gov Identifier: NCT03725202

Suspended due to COVID-19:  Phase III Clinical Trial to Evaluate the Efficacy and Safety of Sarilumab in Patients with Polymyalgia Rheumatica (PMR)

March 20, 2020
Brief Summary:
Primary Objective:

To evaluate the efficacy of KEVZARA (sarilumab) in patients with polymyalgia rheumatica (PMR) as assessed by the proportion of subjects with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen.

Secondary Objectives:

  • To demonstrate the efficacy of sarilumab in patients with polymyalgia rheumatica compared to placebo, in combination with a CS taper with regards to:
  • Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time.
  • Cumulative CS (including prednisone) exposure.
  • To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with PMR.
  • To measure sarilumab serum concentrations in patients with PMR.
  • To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.
    Click here to learn more about this study.
    ClinicalTrials.gov Identifier: NCT03600818

Suspended to COVID-19:  Phase III Clinical Trial:  Evaluation of Efficacy and Safety of Sarilumab in Patients With Giant Cell Arteritis (GCA)

March 2020
Brief Summary:

Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:
To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:

  • Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
  • Cumulative CS (including prednisone) exposure.
  • To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
  • To measure sarilumab serum concentrations in patients with GCA.
  • To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

    Click here to learn more about the study.

    ClinicalTrials.gov Identifier: NCT03600805

Recruiting:  Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s)

Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe GPA. Patients who enter the trial will be maintained on a stable dose of their maintenance immunosuppressive agent which may include methotrexate (MTX), azathioprine (AZA), or mycophenolate (MA) and will undergo a blinded randomization to receive abatacept or placebo. Patients will additionally receive prednisone 30 mg daily that will then be tapered to zero using a standardized tapering schedule.

Click here for more information on ABROGATE.
ClinicalTrials.gov Identifier: NCT02108860

Suspended due to COVID-19:  Phase II Clinical Trial to Evaluate the Efficacy and Safety of Mavrilimumab in Patients with Giant Cell Arteritis (GCA)

Brief Summary:

Primary Objective:

To evaluate the efficacy of sarilumab in patients with giant cell arteritis (GCA) as assessed by the proportion of patients with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course.

Secondary Objective:

  • To demonstrate the efficacy of sarilumab in patients with GCA compared to placebo, in combination with CS taper with regards to:
  • Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time.
  • Cumulative CS (including prednisone) exposure.
  • To assess the safety (including immunogenicity) and tolerability of sarilumab in patients with GCA.
  • To measure sarilumab serum concentrations in patients with GCA.
  • To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).

Click here to learn more about the study.
ClinicalTrials.gov Identifier: NCT03600805