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New treatment option for Granulomatosis With Polyangiitis
Official title Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis
ClinicalTrials.gov ID: NCT04871191
What this study is testing
What is Rituximab?
Rituximab is an investigational medicine, being studied as a potential treatment for granulomatosis with polyangiitis.
Also referred to as Mabthera.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to identify the most promising therapeutic strategy for patients with granulomatosis with polyangiitis and inadequate response to standard of care therapy. It will evaluate the efficacy to induce remission of three different salvage strategies including: a combination of rituximab with addition of a conventional disease-modifying antirheumatic drugs (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or tofacitinib.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Newly diagnosed or relapsing granulomatosis with polyangiitis according to American College of Rheumatology criteria, EMA classification algorithm...
- Aged 18 years or older
- Active clinical manifestations attributable to GPA
- An inadequate response to previous standard of care therapy including either :
- A combination of glucocorticoids plus cyclophosphamide
You likely can't join if
- An allergy or hypersensitivity to monoclonal antibodies or either of the study drugs (rituximab, abatacept or tocilizumab) or to their excipients
- A previous treatment with a combination of rituximab plus a cDMARD, with tofacitinib, or with tocilizumab
- A contraindication to a combination of rituximab plus a cDMARD, to tofacitinib, or to tocilizumab (including an ongoing infection; history of recent...
- Patients with severe vasculitis manifestations that requires plasma exchange therapy including severe renal failure with a creatinine level ≥350...
- Patients with vasculitis in remission
- Patients with symptoms attributable to chronic and non-active GPA
See the full eligibility criteria
- Newly diagnosed or relapsing granulomatosis with polyangiitis according to American College of Rheumatology criteria, EMA classification algorithm and/or the 2012 revised Chapel Hill Consensus Conference definition.
- Aged 18 years or older
- Active clinical manifestations attributable to GPA
- An inadequate response to previous standard of care therapy including either :
- A combination of glucocorticoids plus cyclophosphamide
- AND /OR a combination of glucocorticoids plus rituximab
- An inadequate response to treatment defined as follows:
- A progressive disease unresponsive to previous standard of care therapy after 12 weeks of treatment
- Or a lack of response, defined as \< 50% reduction in the disease activity score, after 12 weeks of treatment
- Or a persistent active disease attributable to either a vasculitic or a granulomatous manifestation of GPA that requires the maintenance of corticosteroids ≥ 7.5 mg/day of equivalent prednisone after ≥ 12 weeks of...
- A stable dose of oral glucocorticoids of ≥ 7.5 mg/day of equivalent prednisone within the 4 weeks before enrollment. Pulses of methylprednisolone (1 to 3 pulses of 7.5 to 15 mg/kg each; ≤ 1000 mg) are allowed if...
- A stable dose of conventional disease-modifying anti-rheumatic drugs (cDMARD) within 4 weeks before enrollment if the patient is currently treated with a cDMARD
- Patients must have the ability to understand the requirements of the study, provide written informed consent prior to participation in the study (including consent for the use and disclosure of research-related health...
- Patients must have an affiliation with a mode of social security (profit or being entitled)
- An allergy or hypersensitivity to monoclonal antibodies or either of the study drugs (rituximab, abatacept or tocilizumab) or to their excipients
- A previous treatment with a combination of rituximab plus a cDMARD, with tofacitinib, or with tocilizumab
- A contraindication to a combination of rituximab plus a cDMARD, to tofacitinib, or to tocilizumab (including an ongoing infection; history of recent cancer \<5 years before enrollment, except for cured non-melanoma skin...
- Patients with severe vasculitis manifestations that requires plasma exchange therapy including severe renal failure with a creatinine level ≥350 µmol/L or severe alveolar haemorrhage
- Patients with vasculitis in remission
- Patients with symptoms attributable to chronic and non-active GPA
- Patients with severe cardiac failure defined as class IV in New York Heart Association
- Patients with acute infections or chronic active infections (including HIV, HBV or HCV)
- Patients with active cancer or recent cancer (\<5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment
- Pregnant women and lactation. All women with childbearing potential are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception from the date of...
- Patients with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol
- Patients included in other investigational therapeutic study within the previous 3 months
- Patients suspected not to be observant to the proposed treatments
- Laboratory parameter exclusions
- aspartate or alanine aminotransferase (AST/SGOT or ALT/SGPT) \> 5 times upper limit of normal
- Platelet count \<100.000/mm3
- White blood cell count \<2000/mm3
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.