A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis

Conditions

• Wegener's Granulomatosis or Microscopic Polyangiitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Methylprednisolone — DRUG
  Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
• Prednisone — DRUG
  Prednisone will be administered orally at tapered dose (start at 1 milligrams per kilogram per day \[mg/kg/day\]) at the discretion of investigator given daily until participants are off the drug.
• Rituximab — DRUG
  Rituximab will be administered at 375 milligrams per meter square (mg/m\^2) of body surface area given by IV infusion once weekly from Week 1 to 4.

Study Details

This is a perspective, Phase IV, multi-center, single arm, open-label, interventional study in adult participants with Wegener's granulomatosis (granulomatosis with polyangiitis \[GPA\]) or microscopic polyangiitis. Participants will be treated with rituximab (Ristova) and glucocorticoids. Rituximab will be administered by intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m\^2) body surface area once weekly during Weeks 1 to 4. Participants will also receive one or three pulses of methylprednisolone (1000 milligram \[mg\] each), followed by a tapering dose of oral prednisolone (start dose of 1 mg per kilogram per day). The dose of oral prednisone will be reduced as per evaluation by the investigator till the participant is completely off the drug. The participants will be followed up for duration of 6 months from the date of starting rituximab therapy with three follow-up visits at Days 52, 112 and 172. All adverse events occurring during this period will be captured.

Key Dates

Start date

Jul 6, 2015

Status verified

Jul 2022

Primary completion

Jun 7, 2022

Completion

Jun 7, 2022

Study Design

Enrollment

30 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Participants will receive IV infusion of rituximab once weekly from Week 1 to 4. Participants will also receive one pulse of methylprednisolone, followed by a tapering dose of oral prednisolone at the discretion of the investigator. Methylprednisolone may be repeated up to total of 3 pulses at the discretion of the investigator.

Primary Outcome Measure

Percentage of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Baseline up to 6 months ]