SATELITE “Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis”

SATELITE “Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” - SATELITE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000679-35-FR

Enrollment

Registered

2021-06-25

Start date

2021-09-07

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatosis with Polyangiitis

Interventions

Trade Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 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 (2) Aged 18 years or older (3) Active clinical manifestations attributable to GPA (4) An inadequate response to previous standard of care therapy including: a. Both a combination of glucocorticoids plus cyclophosphamide and a combination of glucocorticoids plus rituximab b. Or an inadequate response to a combination of glucocorticoids plus rituximab and a contraindication to cyclophosphamide (5) An inadequate response to treatment defined as follows: a. A progressive disease unresponsive to previous standard of care therapy after 12 weeks of treatment b. Or a lack of response, defined as ?50% reduction in the disease activity, after 12 weeks of treatment c. 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 treatment (6) 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 necessary, according to severity before starting the experimental treatment (7) 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 (8) 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 information) and comply with the study protocol procedures (including required study visits) (9) Patients must have an affiliation with a mode of social security (profit or being entitled) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21

Exclusion criteria

Exclusion criteria: (1) An allergy or hypersensitivity to monoclonal antibodies or either of the study drugs (rituximab, prednisone, abatacept or tocilizumab) or to their excipients (2) A previous treatment with a combination of rituximab plus a cDMARD, with abatacept, or with tocilizumab (3) A contraindication to a combination of rituximab plus a cDMARD, to abatacept, or to tocilizumab (including an ongoing infection; history of recent cancer 5 times upper limit of normal b. Platelet count <100.000/mm3 c. White blood cell count <2000/mm3 (15) Hepatic Failure

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to identify the most promising therapeutic strategy for patients with inadequate response to standard of care therapy in granulomatosis with polyangiitis. 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 (cDMARD) (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or abatacept.;Secondary Objective: To evaluate the safety profile (adverse events), the corticosteroids dose, the sequelae, the functional disability and quality of life, the patient-reported outcomes (PRO) and the evolution of ANCA titers in each salvage therapy group. ;Primary end point(s): The primary endpoint will be the proportion of patients with a response or a remission at 12 weeks as defined according to the EULAR recommendations. Remission is defined as the absence of disease activity attributable to active disease qualified by the need for ongoing stable maintenance immunosuppressive therapy. The term ‘‘active disease’’ is not restricted to vasculitis only, but also includes other inflammatory features like granulomatous inflammation. Response is defined as a 50% reduction of disease activity score and absence of new manifestations. Evaluation of remission and response will be determined according to the EULAR recommendations by the investigator in charge of the patient and secondarily validated blindly by an Endpoint Adjudication Committee.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: The primary objective of this study is to identify the most promising therapeutic strategy for patients with inadequate response to standard of care therapy in granulomatosis with polyangiitis. 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 (cDMARD) (either methotrexate, azathioprine or mycophenolate mofetil, but preferentially methotrexate); tocilizumab; or abatacept.;Secondary Objective: To evaluate the safety profile (adverse events), the corticosteroids dose, the sequelae, the functional disability and quality of life, the patient-reported outcomes (PRO) and the evolution of ANCA titers in each salvage therapy group. ;Primary end point(s): The primary endpoint will be the proportion of patients with a response or a remission at 12 weeks as defined according to the EULAR recommendations. Remission is defined as the absence of disease activity attributable to active disease qualified by the need for ongoing stable maintenance immunosuppressive therapy. The term ‘‘active disease’’ is not restricted to vasculitis only, but also includes other inflammatory features like granulomatous inflammation. Response is defined as a 50% reduction of disease activity score and absence of new manifestations. Evaluation of remission and response will be determined according to the EULAR recommendations by the investigator in charge of the patient and secondarily validated blindly by an Endpoint Adjudication Committee.;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - The proportion of patients with a response or a remission according to the EULAR recommendations at week 26 and 52. - The difference between the physician’s and patient’s global assessment of disease activity between baseline and week 12 and between baseline and week 52. - The patient-reported outcomes (PRO) including: HAQ, SF-36 and VAA-PRO at week 12, 24 and 52. - The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at week 26 and 52 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions. - The area under the curve for corticosteroids at week 26 and 52. - The Vasculitis Damage Index at week 26 and 52. - Evolution of ANCA titers in the treatment groups.;Timepoint(s) of evaluation of this end point: 52 weeks	—

Measure

Time frame

Secondary end point(s): - The proportion of patients with a response or a remission according to the EULAR recommendations at week 26 and 52. - The difference between the physician’s and patient’s global assessment of disease activity between baseline and week 12 and between baseline and week 52. - The patient-reported outcomes (PRO) including: HAQ, SF-36 and VAA-PRO at week 12, 24 and 52. - The number of adverse events, expressed as adverse events according to the CTCAE toxicity grading system per patient-year at week 26 and 52 for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hemorraghic cystitis, malignancies, venous thromboembolic events, hospitalization resulting either from the disease or from a complication due to the study treatment, infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions. - The area under the curve for corticosteroids at week 26 and 52. - The Vasculitis Damage Index at week 26 and 52. - Evolution of ANCA titers in the treatment groups.;Timepoint(s) of evaluation of this end point: 52 weeks

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

karine.goude@aphp.fr0144841722

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026