BridgeMD
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)
EU CTIS ID: 2024-516168-27-00
What this study is testing
To assess the superiority at W52 of a combination subcutaneous belimumab weekly over a 24 weeks period (Arm A) or subcutaneous placebo weekly during 24 weeks period (Arm B) with rituximab (or biosimilar) (at a fixed dose of 1,000 mg on Day 7 and Days 21)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Informed consent
- Affiliated to, or beneficiary of, a social security regime or similar
- Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008)
- Previous transient response to first-line treatments of corticosteroids and/or IgIV characterized by a rise of platelet levels > 30 G/L with at least a twofold increase from baseline levels followed by a relapse.
- Platelet count ≤ 30 x 109/L within the previous month or <50 x 109/L G/L if presence of haemorrhagic events or other reason left up to investigator discretion.
You likely can't join if
- Splenectomy
- Persons deprived of their liberty by judicial or administrative decision
- Persons admitted to a health or social establishment for purposes other than research
- Psychiatric Illness impairing judgment
- Persons under legal protection (guardianship, curatorship),
- Persons unable to express their consent
See the full eligibility criteria
- Age ≥ 18 years
- Informed consent
- Affiliated to, or beneficiary of, a social security regime or similar
- Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008)
- Previous transient response to first-line treatments of corticosteroids and/or IgIV characterized by a rise of platelet levels > 30 G/L with at least a twofold increase from baseline levels followed by a relapse.
- Platelet count ≤ 30 x 109/L within the previous month or <50 x 109/L G/L if presence of haemorrhagic events or other reason left up to investigator discretion.
- ITP duration of more than 2 months but less than 10 years from diagnosis.
- Negative pregnancy test results and effective contraception for women of childbearing age Female subjects of childbearing potential must not become pregnant and so must be sexually inactive by abstinence or use contraceptive methods with a failure rate of < 1%.
- Gammaglobulin level ≥ 7 g/L
- Splenectomy
- Persons deprived of their liberty by judicial or administrative decision
- Persons admitted to a health or social establishment for purposes other than research
- Psychiatric Illness impairing judgment
- Persons under legal protection (guardianship, curatorship),
- Persons unable to express their consent
- Common variable immunodeficiency
- Previous treatment with cyclophosphamide or ciclosporin
- Inclusion in another clinical trial less than 3 months before inclusion
- Previous anaphylactic shock
- Chronic or ongoing severe infection requiring treatment or hospitalization in the 60 days preceding inclusion
- Previous history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant.
- Use of parenteral antibiotics within 60 days, current use of suppressive therapy for chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, HSZ, herpes zoster, and atypical mycobacteria
- Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
- Neutrophils count < 1,000/mm3 at inclusion
- Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen or core antibody (HbsAg or HBcAb)
- Impaired renal function as indicated by a serum creatinine level > 2 mg/dl
- Liver function: AST (SGOT) and ALT (SGPT) ≥5xULN Total bilirubin ≥3 x ULN
- New York Heart Classification III or IV heart disease
- Previous history of malignancy in the last 5 years other than cutaneous carcinoma
- Previous history of Progressive multifocal leukoencephalopathy
- Previous history of Severe cutaneous adverse reactions (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis)
- Alcohol or drug abuse or dependence, either current or within 1year
- Previous treatment with rituximab or any B-cell targeted therapy
- Pregnant or breast-feeding woman
- Live, attenuated vaccinations must be administered at least 30 days before inclusion in study
- History of significant medical illness or clinically significant laboratory abnormality (or planned surgical procedure) which in the opinion of the investigator would interfere with the study procedures and / or assessments or compromise subject safety
- Body mass index > 40
- Vulnerable persons, under the protection of justice,
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.