Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00104299
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Microscopic Polyangiitis
  • Vasculitis
  • Wegener's Granulomatosis

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab plus cyclophosphamide placebo (rituximab group) — DRUG
    375 mg/m\^2 infusions once weekly for 4 week
  • Cyclophosphamide plus rituximab placebo (control group) — DRUG
    2 mg/kg/day orally for months 1-3
  • Azathioprine — DRUG
    2 mg/kg/day orally for months 4-6
  • Methylprednisolone (or other glucocorticoid) — DRUG
    1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab
  • Prednisone — DRUG
    During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.

Study Details

Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.

Key Dates

Start date
Jan 31, 2005
Status verified
Mar 2017
Primary completion
Dec 31, 2008
Completion
Jan 31, 2010

Study Design

Enrollment
197 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
  • Active Comparator: Control Group

Primary Outcome Measure

Disease Remission [ Time Frame: 6 months post-randomization ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
Johns Hopkins UniversityBaltimoreMaryland21224-
Boston UniversityBostonMassachusetts02118-
Mayo Clinic FoundationRochesterMinnesota55905-
Hospital for Special SurgeryNew YorkNew York10128-
Duke UniversityDurhamNorth Carolina27710-
The Cleveland ClinicClevelandOhio44195-

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALJohns Hopkins University· Baltimore, MDBoston University· Boston, MAMayo Clinic Foundation· Rochester, MNHospital for Special Surgery· New York, NYDuke University· Durham, NC

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