5525: RITAZAREM: An international, open label, randomized controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis

Status: Closed to Enrollment

For Diseases:

Granulomatosis with Polyangiitis (Wegener's)


Granulomatosis with polyangiitis (GPA, Wegener's) and microscopic polyangiitis are types of vasculitis that are known as ANCA-associated vasculitis (AAV). Vasculitis is inflammation of the small blood vessels of your body. There is often an antibody present in the blood of patients with vasculitis, called ANCA, which damages blood vessels in vasculitis. This study will enroll participants whose vasculitis has come back, also known as "relapsing vasculitis."

The RITAZAREM trial will try to find out whether repeating rituximab stops vasculitis from returning and whether it works better than older treatments, such as azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. The trial results will help vasculitis doctors decide the best treatment for future patients who have their vasculitis initially treated with rituximab.

About this Study

This interventional study will include 190 participants from 50 hospitals in Europe, North America, and Australia. Patients will be recruited at the time of relapse. Everyone will receive 4 weekly rituximab infusion and steroids. Patients whose disease is under control by month 4 will be randomized to either receive additional rituximab infusions or azathioprine.

Patients in the rituximab arm will receive treatment until month 20, and those in the azathioprine arm until month 27.

Evaluations will be performed at months 0, 1.5, 3, 4, 8, 12, 16, 20, 24, 27, 30, 36, and every 6 months until the last patient has completed 36 months in the study. Participants can be on study for four years depending upon whether the status of their vasculitis.

Target Enrollment:

To be eligible to participate, you must:

  1. Have a diagnosis of granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis
  2. Current or historical PR3/MPO ANCA positivity by ELISA
  3. Have active or 'relapsing vasculitis'
  4. Be 15 years of age and above

You are not eligible to participate if:

  • Age < 15 years (age < 18 years at centers that do not treat pediatric patients)
  • Have taken certain medications:
    1. Received rituximab or belimumab within the past 6 months
    2. Alemtuzumab or anti-thymocyte globulin (ATG) within the last 12 months
    3. IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months
  • Exclusions related to general health:
    1. Presence of another multisystem autoimmune disease, poorly-controlled asthma, COPD, psoriasis, or inflammatory bowel disease
    2. Infection with HIV; hepatitis B virus, hepatitis C virus, or evidence of active tuberculosis or known active infection or evidence of untreated latent tuberculosis.
    3. History of malignancy within the past five years
    4. Pregnancy or breast feeding.
    5. Unable to follow study guidelines.

Study Participation

This study is taking place in the following North American cities:

  • Ann Arbor, MI
  • Boston, MA
  • Chapel Hill, NC
  • Cleveland, OH
  • Los Angeles, CA
  • New York City NY
  • Philadelphia, PA
  • Pittsburgh, PA
  • Rochester, MN
  • Salt Lake City, UT
  • Hamilton, ON, Canada
  • Toronto, ON, Canada

Please contact Carol McAlear for additional information.

For information about the European and Japanese sites participating in this study:
Please contact Kim Mynard

For additional information on this trial, please visit:
RITAZEREM web site: www.rdcrn.org/vcrc/ritazarem/
Clinicaltrials.gov: clinicaltrials.gov/ct2/show/NCT01697267