Limitations, agreements, and source contact

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

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

certain Agreement

other Details

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

pi Sponsor Employee

false

restriction Type

OTHER

restrictive Agreement

true

limitations And Caveats

description

After Month 6, participants could receive treatment for GPA/MPA in accordance with local standard of care, and this could include additional rituximab infusions and/or other immunosuppressive therapies. Low participant numbers (e.g., 1 subject = 4%).

point Of Contact

email

genentech@druginfo.com

organization

Hoffmann-La Roche

phone

800 821-8590

title

Medical Communications

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Preserved source evidence · Not medical advice