Trial reportArthritis and rheumatism2012
A randomized controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis.
Trial report in Arthritis and rheumatism, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers, 9 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
114 citing papers in PubMed, 9 syntheses or guidelines pooled it, 396 citations in OpenAlex.
- Guidelines on the Use of Therapeutic Apheresis in Clinical Practice-Evidence-Based Approach From the Writing Committee of the American Society for Apheresis: The Tenth Special Issue.Journal of clinical apheresis · 2026Guideline
- Meta-analysis of the efficacy of rituximab in the management of cryoglobulinemic vasculitis.Frontiers in medicine · 2025Pooled it
- Risk factors for relapse in non-infectious cryoglobulinemic vasculitis, including type I cryoglobulinemia: a systematic review.Frontiers in immunology · 2023Pooled it
- Interventions for renal vasculitis in adults.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Systematic Review of Safety and Efficacy of Rituximab in Treating Immune-Mediated Disorders.Frontiers in immunology · 2019Pooled it
- Interventions for chronic non-hypovolaemic hypotonic hyponatraemia.The Cochrane database of systematic reviews · 2018Pooled it
- Treatment for hepatitis C virus-associated mixed cryoglobulinaemia.The Cochrane database of systematic reviews · 2018Pooled it
- Treatment for cryoglobulinemic and non-cryoglobulinemic peripheral neuropathy associated with hepatitis C virus infection.The Cochrane database of systematic reviews · 2014Pooled it
- Tenofovir alafenamide for prevention of HBV reactivation in HBsAg-negative, anti-HBc-positive patients undergoing rituximab-based chemotherapy: A multicenter randomized controlled trial.Hepatology communications · 2025Trial
- Efficacy and safety of long-term treatment with low-dose rituximab for relapsing mixed cryoglobulinemia vasculitis.Clinical rheumatology · 2017Trial
- Peg-IFNα/ribavirin/protease inhibitor combination in hepatitis C virus associated mixed cryoglobulinemia vasculitis: results at week 24.Annals of the rheumatic diseases · 2014Trial
- Diagnostic and therapeutic challenges in rare hematologic entities: monoclonal gammopathy of thrombotic and bleeding significance.Haematologica · 2026Review
- Hepatitis C in Chronic Kidney Disease After the DAA Revolution: Clinical Decisions, Transplantation, and Implementation Challenges.Journal of clinical medicine · 2026Review
- Polyclonal Hyperviscosity Crisis and Severe Depletion Coagulopathy Induced by Therapeutic Plasma Exchange in Sjögren's Syndrome: A Case Report and Therapeutic Dilemma.Reports (MDPI) · 2026Article
- Clinical features and pathogenesis of Sjogrens disease related peripheral neuropathy and their relevance to clinical trials.Communications medicine · 2026Review
- Cryoglobulinemia: An update on classification, pathophysiology, clinical presentation, and management.Journal of internal medicine · 2026Review
- Cryoglobulinemia, monoclonal and mixed cryoglobulinemia syndromes, cryoglobulinemic vasculitis:Frontiers in immunology · 2026Review
- Successful treatment with bortezomib for refractory cryoglobulinemic vasculitis triggered by ischemic non-obstructive coronary artery disease.CEN case reports · 2025Article
- Update on paraproteinemic neuropathy.Current neurology and neuroscience reports · 2025Review
54 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
25 authors at 14 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo conduct a long-term, prospective, randomized controlled trial evaluating rituximab (RTX) therapy for severe mixed cryoglobulinemia or cryoglobulinemic vasculitis (CV).
methodsFifty-nine patients with CV and related skin ulcers, active glomerulonephritis, or refractory peripheral neuropathy were enrolled. In CV patients who also had hepatitis C virus (HCV) infection, treatment of the HCV infection with antiviral agents had previously failed or was not indicated. Patients were randomized to the non-RTX group (to receive conventional treatment, consisting of 1 of the following 3: glucocorticoids; azathioprine or cyclophosphamide; or plasmapheresis) or the RTX group (to receive 2 infusions of 1 gm each, with a lowering of the glucocorticoid dosage when possible, and with a second course of RTX at relapse). Patients in the non-RTX group who did not respond to treatment could be switched to the RTX group. Study duration was 24 months.
resultsSurvival of treatment at 12 months (i.e., the proportion of patients who continued taking their initial therapy), the primary end point, was statistically higher in the RTX group (64.3% versus 3.5% [P < 0.0001]), as well as at 3 months (92.9% versus 13.8% [P < 0.0001]), 6 months (71.4% versus 3.5% [P < 0.0001]), and 24 months (60.7% versus 3.5% [P < 0.0001]). The Birmingham Vasculitis Activity Score decreased only after treatment with RTX (from a mean ± SD of 11.9 ± 5.4 at baseline to 7.1 ± 5.7 at month 2; P < 0.001) up to month 24 (4.4 ± 4.6; P < 0.0001). RTX appeared to be superior therapy for all 3 target organ manifestations, and it was as effective as conventional therapy. The median duration of response to RTX was 18 months. Overall, RTX treatment was well tolerated.
conclusionRTX monotherapy represents a very good option for severe CV and can be maintained over the long term in most patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.