RITUX-PLUS 2 : A phase 3 randomized and double-blind controlled trial comparing the efficacy and safety of rituximab combined with subcutaneous belimumab versus rituximab + placebo in adult patients with persistent or chronic immune thrombocytopenia (ITP)

Conditions

Adult patients with persistent or chronic immune thrombocytopenia

Brief summary

The overall response rate (CR + R) in both arms at W52

Detailed description

Total number of responders (responders + complete responses) at W6, W12, W 24, W36, W52, W78, W104., Duration of severe hypogammaglobulinemia in patients with such complication, Number of patients developing a severe hypogammaglobulinemia (gammaglobulin level < 4 g/dl) in both arms at W12, W24, W36, W52, W78, W104, Variation in gammaglobulin classes and subclass levels throughout the study (W0, W12, W24, W36, W52, W78, W104), Number of severe infections requiring hospitalization during the study, Number of haemorrhagic events evaluated by the Khellaf Score at W6, W12, W24, W36, W52, W78, W104., Platelet levels at W6, W12, W 24, W36, W52, W78, W104, Use of the SF-36 health questionnaire and FACIT-Fatigue scale (Functional assessment of chronic illness therapy) to assess patient’s quality of life at inclusion, W12, W24 and W52, Percentage of each B-cell subpopulation, T Follicular helper population and levels of cytokines (including BAFF) and anti-platelet antibodies at W12, W24, W36, W52, W78, W104.

Related papers

No related papers found yet.

Interventions

DRUGPLACEBO OF BELIMUMAB

DRUGBenlysta 200 mg solution for injection in pre-filled pen.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The overall response rate (CR + R) in both arms at W52	—

Secondary

Measure	Time frame
Total number of responders (responders + complete responses) at W6, W12, W 24, W36, W52, W78, W104., Duration of severe hypogammaglobulinemia in patients with such complication, Number of patients developing a severe hypogammaglobulinemia (gammaglobulin level < 4 g/dl) in both arms at W12, W24, W36, W52, W78, W104, Variation in gammaglobulin classes and subclass levels throughout the study (W0, W12, W24, W36, W52, W78, W104), Number of severe infections requiring hospitalization during the study, Number of haemorrhagic events evaluated by the Khellaf Score at W6, W12, W24, W36, W52, W78, W104., Platelet levels at W6, W12, W 24, W36, W52, W78, W104, Use of the SF-36 health questionnaire and FACIT-Fatigue scale (Functional assessment of chronic illness therapy) to assess patient’s quality of life at inclusion, W12, W24 and W52, Percentage of each B-cell subpopulation, T Follicular helper population and levels of cytokines (including BAFF) and anti-platelet antibodies at W12, W24, W36, W5	—

Measure

Time frame

Total number of responders (responders + complete responses) at W6, W12, W 24, W36, W52, W78, W104., Duration of severe hypogammaglobulinemia in patients with such complication, Number of patients developing a severe hypogammaglobulinemia (gammaglobulin level < 4 g/dl) in both arms at W12, W24, W36, W52, W78, W104, Variation in gammaglobulin classes and subclass levels throughout the study (W0, W12, W24, W36, W52, W78, W104), Number of severe infections requiring hospitalization during the study, Number of haemorrhagic events evaluated by the Khellaf Score at W6, W12, W24, W36, W52, W78, W104., Platelet levels at W6, W12, W 24, W36, W52, W78, W104, Use of the SF-36 health questionnaire and FACIT-Fatigue scale (Functional assessment of chronic illness therapy) to assess patient’s quality of life at inclusion, W12, W24 and W52, Percentage of each B-cell subpopulation, T Follicular helper population and levels of cytokines (including BAFF) and anti-platelet antibodies at W12, W24, W36, W5

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Countries

France

Outcome results

None listed