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Completed

NCT Number: NCT02115997

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

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.

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Key information

Conditions

Wegener's Granulomatosis or Microscopic Polyangiitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Granulomatosis with Polyangiitis Immune System Diseases Lung Diseases Lung Diseases, Interstitial Microscopic Polyangiitis Nervous System Diseases Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yashoda Hospital, Hyderabad, Andhra Pradesh, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or non-pregnant, non-nursing female
  • Diagnosed with Wegener's granulomatosis or Microscopic polyangiitis according to the definitions of the Chapel Hill Consensus Conference
  • Participants with either newly diagnosed or relapsing disease
  • Participants must have active disease as per the BVAS/WG greater than equal to (>/=) 3 that would normally require treatment with cyclophosphamide (CYC)
  • Participants willing to practice medically acceptable contraception during and 1 year after the completion of rituximab therapy
  • Participants must have severe disease i.e. one or more of the major BVAS/WG items depicting severity or disease severe enough to require treatment with CYC.
  • Participants must be positive for either proteinase 3-antineutrophil cytoplasmic antibodies (PR3-ANCA) or myeloperoxidase-antineutrophil cytoplasmic antibodies (MPO-ANCA) at the screening

Exclusion criteria

  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Participants in a severely immunocompromised state
  • Participants with severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease
  • Participants having active severe infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
  • Participants who had a live vaccine fewer than 4 weeks before first dose of rituximab
  • Any other condition which puts the participant to undue risk for rituximab therapy as per local prescribing information or Investigator's judgment
  • Participants with any previous treatment with rituximab
  • Participants with any previous treatment with alemtuzumab
  • Participants who have had treatment with infliximab within the previous 3 months
  • Participants who have had treatment with adalimumab within the previous 2 months
  • Participants who have had treatment with etanercept within the previous month
  • Participants with any other investigational medication within the previous month

Treatment and study plan

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.

Other names: Ristova

Primary outcomes

  1. Percentage of Participants With Adverse Events and Serious Adverse Events

    Time frame: Baseline up to 6 months

  2. Percentage of Participants Who Achieved a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) Score of 0 and Successfully Completed Prednisone Taper at 6 Months

    Time frame: 6 months

Secondary outcomes

  1. Percentage of Participants Who Achieved a BVAS/WG Score of 0 During Treatment With Prednisone at a Dose of Less Than (<) 10 mg/day

    Time frame: 6 months

  2. Percentage of Participants With Refractory Antineutrophil Cytoplasmic Antibodies-Associated Vasculitis (AAV) Who Achieved BVAS/WG Score of 0 and Successfully Completed Prednisone Taper at 6 Months

    Time frame: 6 months

  3. Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2)

    Time frame: 6 months

  4. Number of Severe Flares

    Time frame: At Months 2, 4, 6

  5. Number of Limited Flares

    Time frame: At Months 2, 4, 6

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Apr 16, 2014
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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