Trial reportArthritis research & therapy2021
Efficacy and safety of biosimilar CT-P17 versus reference adalimumab in subjects with rheumatoid arthritis: 24-week results from a randomized study.
Trial report in Arthritis research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03789292 (A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.
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.
A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
Who cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.
- Impact of switching between reference biologics and biosimilars of tumour necrosis factor inhibitors for rheumatoid arthritis: a systematic review and network meta-analysis.Scientific reports · 2023Pooled it
- Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study.Advances in therapy · 2025Trial
- Efficacy and safety of switching from reference adalimumab to CT-P17 (100 mg/ml): 52-week randomized, double-blind study in rheumatoid arthritis.Rheumatology (Oxford, England) · 2022Trial
- Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT-P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects.British journal of clinical pharmacology · 2021Trial
- Self-Injection Satisfaction and Safety of CT-P17 (Yuflyma), a High-Concentration Adalimumab Biosimilar, in Patients With Crohn's Disease: A Cross-Sectional Study.JGH open : an open access journal of gastroenterology and hepatology · 2025Article
- CT-P17 Adalimumab Biosimilar in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: An Open-Label Extension of a Phase 3 Interchangeability Study.Dermatology and therapy · 2025Article
- Patient Satisfaction and Experience with CT-P17 Following Transition from Reference Adalimumab or Another Adalimumab Biosimilar: Results from the Real-World YU-MATTER Study.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Observational
- Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments.Pharmaceutical medicine · 2024Article
- Navigating adalimumab biosimilars: an expert opinion.Journal of comparative effectiveness research · 2023Review
- Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease.Intestinal research · 2023Review
- Stepping Forward to the Next Level: Totality of Evidence for the First High-Concentration Adalimumab Biosimilar, CT-P17.Clinical drug investigation · 2022Review
- Patient-Reported Outcomes in Rheumatoid Arthritis: A Key Consideration for Evaluating Biosimilar Uptake?Patient related outcome measures · 2022Review
- An Update Review of Biosimilars of Adalimumab in Psoriasis - Bioequivalence and Interchangeability.Drug design, development and therapy · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 12 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTo demonstrate equivalent efficacy of the proposed high-concentration (100 mg/ml), citrate-free adalimumab biosimilar CT-P17 to European Union-approved adalimumab (EU-adalimumab) in subjects with active rheumatoid arthritis (RA).
methodsThis randomized, double-blind phase III study ( ClinicalTrials.gov , NCT03789292) randomized (1:1) subjects with active RA at 52 centers to receive CT-P17 or EU-adalimumab 40 mg subcutaneously every 2 weeks until week 52. Results to week 24 are reported here. The primary endpoint was 20% improvement by American College of Rheumatology criteria (ACR20) response rate at week 24. Equivalence was concluded if the corresponding confidence intervals (CIs) for the estimate of treatment difference were within predefined equivalence margins: - 15 to 15% (95% CI; European Medicines Agency assumption); - 12 to 15% (90% CI; Food and Drug Administration assumption). Additional efficacy, pharmacokinetic, usability, safety, and immunogenicity endpoints were evaluated.
results648 subjects were randomized (324 CT-P17; 324 EU-adalimumab). The ACR20 response rate at week 24 was 82.7% (n = 268/324) in both groups (intention-to-treat population). The 95% CI (- 5.94 to 5.94) and 90% CI (- 4.98 to 4.98) were within predefined equivalence margins for both assumptions and equivalent efficacy was concluded. Additional endpoints and overall safety were comparable between groups. Mean trough serum concentrations of CT-P17 were slightly higher than those of EU-adalimumab. Immunogenicity was slightly lower numerically for the CT-P17 group than for the EU-adalimumab group.
conclusionsCT-P17 and EU-adalimumab have equivalent efficacy and comparable safety and immunogenicity in subjects with active RA. Overall safety of CT-P17 is consistent with the known safety profile of reference adalimumab.
trial registrationClinicalTrials.gov, NCT03789292 . Registered 28 December 2018-retrospectively registered.
Indexed as
Identifiers
What OpenQuestion holds
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.