Wegener's Granulomatosis or Microscopic PolyangiitisPhase 4NCT02115997
A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
A Phase 4 study testing Methylprednisolone, Prednisone and Rituximab in people with Wegener's Granulomatosis or Microscopic Polyangiitis, run by Hoffmann-La Roche at 10 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wegener's Granulomatosis or Microscopic Polyangiitis
- What is being tested?
- Methylprednisolone, Prednisone and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesIndia
- Study dates
- 6 Jul 2015to 7 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
St. John's Medical College Hospital; Rheumatology
Bangalore, 560034
Chanre Rheumatology and Immunology Center and Research
Bangalore, 560079
MULJIBHAI PATEL UROLOGICAL HOSPITAL; Nephrology
Gujarat, Gujarat, 387001
Medanta-The Medicity
Gurgaon, Haryana, 122001
Fortis Memorial Research Instititute
Gurgaon, Haryana, 122002
Yashoda Hospital
Hyderabad, Andhra Pradesh, 500082
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; Department of Rheumatologz
Mumbai, Maharashtra, 400053
Apollo BGS Hospitals
Mysuru, Karnataka, 570023
Jasleen Hospital
Nagpur, 440010
Fortis Hospital
Noida, 201 301
About this study
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.
- Being tested
- Methylprednisolone, Prednisone, Rituximab
- Medical subject headings
- Granulomatosis with Polyangiitis, Microscopic Polyangiitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
PrednisoneDrug
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.
RituximabDrug
Also called Ristova
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 group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | 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. Receives: Drug: Methylprednisolone; Drug: Prednisone; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events and Serious Adverse Events
Measured: Baseline up to 6 months
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
Measured: 6 months
Secondary outcomes (5)
Percentage of Participants Who Achieved a BVAS/WG Score of 0 During Treatment With Prednisone at a Dose of Less Than (<) 10 mg/day
Measured: 6 months
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
Measured: 6 months
Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2)
Measured: 6 months
Number of Severe Flares
Measured: At Months 2, 4, 6
Number of Limited Flares
Measured: At Months 2, 4, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study start6 Jul 2015
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wegener's Granulomatosis or Microscopic PolyangiitisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115997
- Sponsor's protocol ID
- ML28550
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2014
- Last updated
- 6 Jul 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis
- ClinicalTrials.gov ID
- NCT02115997
- Acronym / sponsor ID
- ML28550
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Methylprednisolone, Drug: Prednisone, Drug: RituximabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneMethyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator. | Drug | Rituximab |
| PrednisonePrednisone 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 |
| RituximabAlso: RistovaRituximab 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. | Drug | Rituximab |
Primary outcome
Percentage of Participants With Adverse Events and Serious Adverse Events
Time frame: Baseline up to 6 months
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
5 secondary outcomes
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
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
Percentage of Participants Who Achieved and Maintained Partial Remission (Defined as Having a BVAS/WG of 1 or 2)
Time frame: 6 months
Number of Severe Flares
Time frame: At Months 2, 4, 6
Number of Limited Flares
Time frame: At Months 2, 4, 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone, Prednisone and Rituximab in people with Wegener's Granulomatosis or Microscopic Polyangiitis, run by Hoffmann-La Roche at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events and Serious Adverse Events (time frame: Baseline up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.