A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Hoffmann-La Roche
Study ID
NCT01750697
Phase
PHASE2
Status
Completed

Conditions

  • Granulomatosis With Polyangiitis

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Participants will receive rituximab 375 mg/m\^2 IV infusion on Days 1, 8, 15 and 22. Rituximab infusions will be given at a rate of 25 milligrams per hour (mg/h). This may be escalated at a rate of 25 mg/h increments every 30 minutes to a maximum of 200 mg/h.

Study Details

This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m\^2) intravenously (IV) on Days 1, 8, 15 and 22.

Key Dates

Start date
May 23, 2013
Status verified
Jun 2019
Primary completion
May 10, 2018
Completion
May 10, 2018

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs), Including Serious AEs [ Time Frame: Baseline (Day 1) up to last visit (1.5-5 years) ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research UnitLouisvilleKentucky40202-
Hackensack University Medical CenterHackensackNew Jersey07601-
COLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research BuildingNew YorkNew York10032-
Cincinnati Childrens HospitalCincinnatiOhio45229-
The Cleveland Clinic Foundation; Rheumatic and Immunologic DiseasesClevelandOhio44195-
University of Utah; Immunology/Rheumatology/AllergySalt Lake CityUtah84109-

Find similar trials in Louisville, KY

By research site
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit· Louisville, KYHackensack University Medical Center· Hackensack, NJCOLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research Building· New York, NYCincinnati Childrens Hospital· Cincinnati, OHThe Cleveland Clinic Foundation; Rheumatic and Immunologic Diseases· Cleveland, OHUniversity of Utah; Immunology/Rheumatology/Allergy· Salt Lake City, UT

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