Trial reportArthritis & rheumatology (Hoboken, N.J.)2022
Phase II/III Results of a Trial of Anti-Tumor Necrosis Factor Multivalent NANOBODY Compound Ozoralizumab in Patients With Rheumatoid Arthritis.
Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
26 citing papers in PubMed, 63 citations in OpenAlex.
- Trial
- Ozoralizumab shows effectiveness regardless of baseline RF and ACPA titres in patients with RA: a post hoc analysis of the OHZORA trial.Rheumatology (Oxford, England) · 2025Trial
- Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis.RMD open · 2024Trial
- Clinical Benefit and Global Regulation of Bispecific Antibody Drugs: A Cross-sectional Analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Article
- Assessment of drug levels as a biomarker in rheumatoid arthritis.EULAR rheumatology open · 2026Review
- Advances in Nanotechnology for Lymphoma Treatment: Targeted Delivery, Immunomodulation, and TME-Responsive Therapy Strategies.International journal of nanomedicine · 2026Review
- Targeting vascular inflammation and endothelial dysfunction with nanobodies: emerging therapeutic strategies for cardiovascular disease.Frontiers in immunology · 2026Review
- Application of nanobody‑based CAR‑T in tumor immunotherapy (Review).International journal of molecular medicine · 2025Review
- Effect of Ozoralizumab Administration with or without Methotrexate in Patients with Rheumatoid Arthritis: A Post-Hoc Analysis.Rheumatology and therapy · 2025Article
- Rheumatoid Factor: Diagnostic and Prognostic Performance and Therapeutic Implications in Rheumatoid Arthritis.Journal of clinical medicine · 2025Review
- Resolution of inflammation during rheumatoid arthritis.Frontiers in cell and developmental biology · 2025Review
- Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.The Journal of experimental medicine · 2024Review
- Discovery of nanobodies: a comprehensive review of their applications and potential over the past five years.Journal of nanobiotechnology · 2024Review
- Unlocking the potential of bispecific ADCs for targeted cancer therapy.Frontiers of medicine · 2024Review
- Milk-derived extracellular vesicles functionalized with anti-tumour necrosis factor-α nanobody and anti-microbial peptide alleviate ulcerative colitis in mice.Journal of extracellular vesicles · 2024Article
- Next-Generation Anti-TNFα Agents: The Example of Ozoralizumab.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- Small Antibodies with Big Applications: Nanobody-Based Cancer Diagnostics and Therapeutics.Cancers · 2023Review
- Evaluation of the Potential Impact of In Silico Humanization on VInternational journal of molecular sciences · 2023Article
- Immunotherapies in chronic pain through modulation of neuroimmune interactions.Pharmacology & therapeutics · 2023Review
- Efficacy and pharmacokinetics of ozoralizumab, an anti-TNFα NANOBODYArthritis research & therapy · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the efficacy and safety of subcutaneous administration of 30 mg or 80 mg of ozoralizumab plus methotrexate (MTX) in patients with rheumatoid arthritis (RA) whose disease remained active despite MTX therapy.
methodsIn this multicenter, double-blind, parallel-group, placebo-controlled phase II/III trial, 381 patients were randomized to receive placebo, ozoralizumab 30 mg, or ozoralizumab 80 mg, plus MTX subcutaneously injected every 4 weeks for 24 weeks. The primary end points were the response rates based on the American College of Rheumatology 20% improvement criteria (ACR20) at week 16 and change in the Sharp/van der Heijde score (ΔSHS) from baseline to week 24.
resultsThe proportion of patients with an ACR20 response at week 16 was significantly higher (P < 0.001) in both ozoralizumab groups (79.6% for 30 mg, 75.3% for 80 mg), compared with placebo (37.3%); these improvements were observed from the first week of treatment. The proportion of the patients with structural nonprogression (ΔSHS ≤0) was significantly higher in both ozoralizumab groups than in the placebo group. For some secondary end points, significantly greater improvements were observed starting from as early as day 3. Serious adverse events occurred in 4 patients in the ozoralizumab 30-mg group and 5 patients in the ozoralizumab 80-mg group.
conclusionIn patients with active RA who received ozoralizumab in combination with MTX, the signs and symptoms of RA were significantly reduced as compared with the outcomes in those receiving placebo. Ozoralizumab demonstrated acceptable tolerability with no new safety signals when compared with other antibodies against tumor necrosis factor.
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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.