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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.
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
Arms & Interventions
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.
Interventions
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.
International Sites
Yashoda Hospital, Hyderabad, Andhra Pradesh, India