Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

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Brief Title

Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Official Title

Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study

Brief Summary

      Rituximab is the first drug approved by the United States Food and Drug Administration (FDA)
      for the treatment of patients with granulomatosis with polyangiitis (Wegener's
      granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the
      long-term safety and efficacy of this drug is not yet clear. This study proposes to follow
      patients who were enrolled in the RAVE study to determine if treatment with rituximab
      influences long-term outcomes.
    



Study Type

Observational


Primary Outcome

Long-term safety of rituximab for the treatment of ANCA-associated vasculitis

Secondary Outcome

 Disease activity

Condition

Granulomatosis With Polyangiitis

Intervention

Observational

Study Arms / Comparison Groups

 RAVE subjects
Description:  

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

Other

Estimated Enrollment

67

Start Date

May 2012

Completion Date

May 15, 2014

Primary Completion Date

May 15, 2014

Eligibility Criteria

        Inclusion Criteria:

          1. Enrollment in the RAVE trial

          2. Completion of RAVE Common Closeout Date visit

          3. Informed consent

        Exclusion Criteria:

          1. Refusal to participate

          2. Inability to comply with standard-of-care, including routine clinical visits and
             testing.
      

Gender

All

Ages

12 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Philip Seo, MD, , 

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT01586858

Organization ID

ML27815


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 University of Alabama at Birmingham

Study Sponsor

Philip Seo, MD, Study Director, Johns Hopkins University


Verification Date

October 2017