Learn about Research & Clinical Trials
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Hoffmann-La Roche|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Wegener's Granulomatosis or Microscopic Polyangiitis|
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.
Drug: - Methylprednisolone
Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
Drug: - Prednisone
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.
Drug: - Rituximab
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.
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.