Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2017
Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01534884 (Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis), which is not on this map. Cited by 16 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.
Phase 1, Randomized, Controlled, Multicenter, 2-Arm, Parallel-Group, Double-Blind Study to Demonstrate the Equivalence of CT-P10 to MabThera With Respect to the Pharmacokinetic Profile in Patients With Rheumatoid Arthritis
Who cites it
16 citing papers in PubMed, 32 citations in OpenAlex.
- Trial
- Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.Rheumatology (Oxford, England) · 2019Trial
- Trial
- Safety and effectiveness of rituximab biosimilar (Rituximab-GP2013) versus originator in rheumatoid arthritis: real-world evidence from a single center.Clinics (Sao Paulo, Brazil) · 2026Article
- Incidence and implications of anti-rituximab antibodies in nephropathies and other immune-mediated diseases: a narrative review.Frontiers in immunology · 2026Review
- Interchangeability and adverse events in originator-rituximab and its biosimilar (CT-P10) among rheumatic patients: a real-life experience.Internal and emergency medicine · 2023Article
- Article
- Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Osteoporosis in patients with rheumatoid arthritis is associated with serum immune regulatory cellular factors.Clinical rheumatology · 2022Article
- The safety and clinical effectiveness of rapid infusion with CT-P10 in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia: A retrospective non-interventional post-authorization safety study in Europe.Hematological oncology · 2022Article
- Development of anti-rituximab antibodies in rituximab-treated patients: Related parameters & consequences.The Indian journal of medical research · 2022Review
- Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Comparison of Rituximab Originator With CT-P10 Biosimilar in Patients With Primary Sjögren's Syndrome: A Retrospective Analysis in a Real-Life Setting.Frontiers in medicine · 2020Article
- Comparison of the Efficacy of Innovator Rituximab and its Biosimilars in Diffuse Large B Cell Lymphoma Patients: A Retrospective Analysis.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2020Article
- Targeting CD20: teaching an old dog new tricks.Hematology. American Society of Hematology. Education Program · 2019Review
- Past, Present, and Future of Rituximab-The World's First Oncology Monoclonal Antibody Therapy.Frontiers in oncology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
21 authors at 17 institutions in 6 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundCT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents.
objectiveOur objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks.
methodsIn this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2. Based on disease activity, patients could receive a second course of treatment between weeks 24 and 48. Efficacy endpoints, including mean change from baseline in Disease Activity Score using 28 joints (DAS28), safety, immunogenicity, pharmacokinetics, and pharmacodynamics were evaluated.
resultsIn total, 154 patients were randomized to CT-P10 or RTX (n = 103 and 51, respectively); 137 (n = 92 and 45) completed the first course of treatment, of whom 83 (n = 60 and 23) were re-treated. Improvements from baseline in all efficacy endpoints were highly similar between the CT-P10 and RTX groups over both treatment courses. At week 24 after the second course, mean change from week 0 of the first course in DAS28 erythrocyte sedimentation rate was -2.47 and -2.04 for CT-P10 and RTX, respectively, (p = 0.1866) and in DAS28 C-reactive protein was -2.32 and -2.00, respectively (p = 0.3268). The proportion of patients positive for antidrug antibodies at week 24 after the second treatment course was 20.0% and 21.7% in the CT-P10 and RTX groups, respectively. The safety profile of CT-P10 was comparable to that of RTX, and pharmacokinetic and pharmacodynamic properties were similar.
conclusionsIn patients with RA, efficacy, safety, and other clinical data were comparable between CT-P10 and RTX after up to two courses of treatment over 72 weeks. (ClinicalTrials.gov identifier NCT01534884).
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