Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis

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Brief Title

Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis

Official Title

Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

Brief Summary

      The purpose of this pilot study is to test whether an 8-week course of glucocorticoids,
      combined with rituximab, is effective in treating ANCA-associated vasculitis.
    

Detailed Description

      The primary aim of this pilot study is to examine whether an 8 week course of
      glucocorticoids, in combination with rituximab, is effective in inducing and maintaining
      disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis
      (AAV) who have a more favorable prognosis.

      This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure
      that any patients who require courses of glucocorticoids longer than two months will receive
      longer therapy, if appropriate for their well-being.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Complete Remission

Secondary Outcome

 Disease Response

Condition

Granulomatosis With Polyangiitis

Intervention

Glucocorticoids

Study Arms / Comparison Groups

 Glucocorticoids and Rituximab
Description:  This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

June 2014

Completion Date

November 1, 2017

Primary Completion Date

August 17, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients ages 18-85 years old

          -  Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus
             Conference

          -  New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's
             granulomatosis (BVAS/WG) of > 3

        Exclusion Criteria:

          -  Renal disease in patients with PR3-ANCA as defined by any of the following:

          -  Urinary red blood cell casts

          -  Biopsy-proven glomerulonephritis

          -  Increase in serum creatinine of >30% over baseline

          -  Severe renal disease in patients with MPO-ANCA as defined by both of the following:

          -  Urinary red blood cell casts or biopsy-proven glomerulonephritis

          -  Estimated glomerular filtration rate < 30 ml/min/1.73m2

          -  Diffuse alveolar hemorrhage requiring ventilatory support

          -  GC treatment for longer than 14 days prior to enrollment unless patient has been on a
             stable maintenance dose of prednisone at the time of the flare

          -  Daily oral cyclophosphamide within 1 month prior to enrollment

          -  Completed a remission induction course of cyclophosphamide or rituximab within 4
             months of enrollment

          -  Hepatitis B infection

          -  HIV infection

          -  History of anti-GBM disease

          -  Other uncontrolled disease, including drug and alcohol abuse, that may interfere with
             the study

          -  Pregnancy or breastfeeding

          -  History of severe allergic reactions to human or chimeric monoclonal antibodies
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

John H Stone, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02169219

Organization ID

2012P001427


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital

Collaborators

 Genentech, Inc.

Study Sponsor

John H Stone, MD, Principal Investigator, Massachusetts General Hospital and Harvard Medical School


Verification Date

July 2018