Actively Recruiting
Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-06-26
48
Participants Needed
20
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Cryoglobulinemia vasculitis (CV) is a systemic immune-mediated small vessel vasculitis. Rituximab proved effective on main vasculitis signs, with a complete clinical response of 65%. However, CV relapse is noted in up to 40% of patients. Following rituximab, serum Blys concentration significantly increased and may favor relapses. Tribeca is a multicentre randomized controled study comparing safety and efficacy of belimumab to placebo in non infectious cryoglobulinemia vasculitis.
CONDITIONS
Official Title
Efficacy and Safety of Belimumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Compared to Placebo. TRIBECA STUDY (Treatment nd BElimumab in Cryoglobulinemia Associated Vasculitis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Written informed consent provided
- Active mixed cryoglobulinemia vasculitis with clinical signs in skin, joints, kidneys, nerves, central nervous system, digestive, lungs, or heart
- History of positive cryoglobulinemia or rheumatoid factor with low C4 complement, monoclonal IgM Kappa, or biopsy proof of vasculitis
- Affiliated with the French national social security system
- Received rituximab as induction therapy within 6 weeks before inclusion
- Negative pregnancy test for women of childbearing potential at inclusion and monthly during study
- Willingness to use effective contraception or abstinence during study and for 92 days after last dose
- Negative HIV, hepatitis B and C tests before inclusion
- Neutrophil count greater than 1x10^9/L
You will not qualify if you...
- Vasculitis unrelated to cryoglobulinemia
- Inactive cryoglobulinemia vasculitis at rituximab initiation
- Use of certain investigational biologic agents within 365 days before study
- Use of intravenous cyclophosphamide within 180 days before study
- Use of non-biologic investigational agents within 30 days before study
- Live vaccines within 30 days before or during study
- History of malignant cancer within 5 years except certain skin cancers and low-grade blood disorders
- Serious suicide risk or recent suicidal behavior
- Progressive multifocal leukoencephalopathy
- Primary immunodeficiency history
- History of major organ or stem cell transplant
- Current suppressive therapy for chronic infection
- Infection requiring hospitalization or IV/IM antibiotics within 60 days before inclusion
- Current or recent drug or alcohol abuse within 365 days
- Positive HIV test within 3 months before inclusion
- Positive hepatitis B or C RNA test within 3 months before inclusion
- History of allergic reaction to belimumab, corticosteroids, or study treatment components
- Pregnant or breastfeeding women
- Significant medical or psychiatric illness making participation unsuitable
- Under legal protection or unable to consent
- Participation in another interventional study
AI-Screening
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Trial Site Locations
Total: 20 locations
1
CH Blois
Blois, France
Actively Recruiting
2
CHU (Haut-Lévêque)
Bordeaux, France
Actively Recruiting
3
CHU Caen
Caen, France
Actively Recruiting
4
Hopital Henri Mondor
Créteil, France
Not Yet Recruiting
5
Hopital Bicetre
Le Kremlin-Bicêtre, France
Actively Recruiting
6
CHU Lille
Lille, France
Actively Recruiting
7
CHU La Conception
Marseille, France
Actively Recruiting
8
CHU Nantes
Nantes, France
Actively Recruiting
9
CH Nimes
Nîmes, France
Actively Recruiting
10
Hopital de La Pitié Salpetriere AP-HP
Paris, France
Actively Recruiting
11
Hopital Européen Georges Pompidou
Paris, France
Actively Recruiting
12
Hopital Necker
Paris, France
Actively Recruiting
13
Hopital Saint Antoine
Paris, France
Actively Recruiting
14
Hopital Saint Louis
Paris, France
Actively Recruiting
15
Hopital Tenon
Paris, France
Actively Recruiting
16
CHU Starsbourg
Strasbourg, France
Actively Recruiting
17
Hopital Foch
Suresnes, France
Actively Recruiting
18
CHU Toulouse
Toulouse, France
Actively Recruiting
19
CHU Tours
Tours, France
Actively Recruiting
20
CHU Valenciennes
Valenciennes, France
Actively Recruiting
Research Team
D
David Saadoun, MD PhD
CONTACT
J
Jérôme Lambert, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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