Participant flow

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.

   id

   FG000

   title

   Rituximab

2. description

   Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.

   id

   FG001

   title

   Control Group

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      To have renal transplant

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         98

      type

      STARTED

   2. achievements

      1. comment

         Number of participants who completed 18 months post-randomization

         group Id

         FG000

         num Subjects

         90

      2. comment

         Number of participants who completed 18 months post-randomization

         group Id

         FG001

         num Subjects

         88

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.

recruitment Details

Eight centers in the United States and one center in the Netherlands (Groningen) enrolled 197 Antineutrophil cytoplasmic antibodies (ANCA)-positive patients with either Wegener's granulomatosis or microscopic polyangiitis between December 30, 2004 and June 30, 2008.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice