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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02115997
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hoffmann-La Roche
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries India
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Wegener's Granulomatosis or Microscopic Polyangiitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Christian Med Clg & Hspt, Vellore, India

Status

Withdrawn

Address

Christian Med Clg & Hspt

Vellore, , 632004

New Delhi, India

Status

Recruiting

Address

Indraprastha Apollo Hospitals; Department of Rheumatology

New Delhi, , 110076

New Delhi, India

Status

Withdrawn

Address

All India Institute of Medical Sciences (AIIMS); Rheumatology

New Delhi, , 110029

Max Super Speciality Hospital, New Delhi, India

Status

Terminated

Address

Max Super Speciality Hospital

New Delhi, , 110017

Jasleen Hospital, Nagpur, India

Status

Active, not recruiting

Address

Jasleen Hospital

Nagpur, , 440010

Medica Superspeciality Hospital, Kolkata, India

Status

Withdrawn

Address

Medica Superspeciality Hospital

Kolkata, , 700099

Gujarat, India

Status

Recruiting

Address

MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology

Gujarat, , 387001

Bangalore, India

Status

Active, not recruiting

Address

Chanre Rheumatology and Immunology Center and Research

Bangalore, , 560079

Bangalore, India

Status

Recruiting

Address

St. John's Medical College Hospital; Rheumatology

Bangalore, , 560034

Manipal Hospital, Bangalore, India

Status

Not yet recruiting

Address

Manipal Hospital

Bangalore, , 560017

Fortis Hospital, Noida, Uttar Pradesh, India

Status

Active, not recruiting

Address

Fortis Hospital

Noida, Uttar Pradesh, 201301

Mumbai, Maharashtra, India

Status

Completed

Address

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz

Mumbai, Maharashtra, 400053

Apollo BGS Hospitals, Mysuru, Karnataka, India

Status

Recruiting

Address

Apollo BGS Hospitals

Mysuru, Karnataka, 570023

Fortis Memorial Research Instititute, Gurgaon, Haryana, India

Status

Active, not recruiting

Address

Fortis Memorial Research Instititute

Gurgaon, Haryana, 122002

Medanta-The Medicity, Gurgaon, Haryana, India

Status

Active, not recruiting

Address

Medanta-The Medicity

Gurgaon, Haryana, 122001

Sir Gangaram Hospital, New Delhi, Delhi, India

Status

Not yet recruiting

Address

Sir Gangaram Hospital

New Delhi, Delhi, 110060

Yashoda Hospital, Hyderabad, Andhra Pradesh, India

Status

Recruiting

Address

Yashoda Hospital

Hyderabad, Andhra Pradesh, 500082

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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