Trial reportRheumatology (Oxford, England)2021
Open-label phase 3 study of intravenous golimumab in patients with polyarticular juvenile idiopathic arthritis.
Trial report in Rheumatology (Oxford, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02277444 (A Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy), which is not on this map. Cited by 18 papers, 3 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 Multicenter, Open-Label Trial of Intravenous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
Who cites it
18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Pediatric Society of the African League Against Rheumatism juvenile idiopathic arthritis recommendations for enthesitis-related arthritis and juvenile psoriatic arthritis.Clinical rheumatology · 2025Guideline
- Tumor necrosis factor (TNF) inhibitors for juvenile idiopathic arthritis.The Cochrane database of systematic reviews · 2025Pooled it
- Efficacy and safety of TNF inhibitors in the treatment of juvenile idiopathic arthritis: a systematic literature review.Pediatric rheumatology online journal · 2023Pooled it
- Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK).Rheumatology (Oxford, England) · 2023Trial
- Efforts towards a precision medicine approach in juvenile idiopathic arthritis.Rheumatology (Oxford, England) · 2026Review
- Recent Advances in the Pharmacological Management of Pediatric Spondyloarthritis.Paediatric drugs · 2026Review
- 25 Years of Biologics for the Treatment of Pediatric Rheumatic Disease: Advances in Prognosis and Ongoing Challenges.Arthritis care & research · 2025Review
- Children With Inflammatory Bowel Diseases are Disadvantaged by Current Drug Approval Policies: A Call for Urgent Change.Crohn's & colitis 360 · 2025Article
- Health-Related Quality of Life in Juvenile Idiopathic Arthritis: A Systematic Review of Phase III Clinical Trials.Journal of clinical medicine · 2025Review
- Safety and efficacy of tofacitinib for the treatment of patients with juvenile idiopathic arthritis: preliminary results of an open-label, long-term extension study.Annals of the rheumatic diseases · 2024Article
- Patterns and determinants of response to novel therapies in juvenile and adult-onset polyarthritis.Rheumatology (Oxford, England) · 2024Review
- Advances in the Diagnosis and Treatment of Enthesitis-Related Arthritis.Children (Basel, Switzerland) · 2023Review
- Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.Arthritis & rheumatology (Hoboken, N.J.) · 2023Article
- Golimumab for Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis: Pharmacologic and Clinical Considerations.Life (Basel, Switzerland) · 2023Review
- Juvenile idiopathic arthritis.Nature reviews. Disease primers · 2022Review
- Biologic Disease-Modifying and Other Anti-Rheumatic Drugs Use in Patients with Moderate-to-Severe Juvenile Idiopathic Arthritis Based on a Japanese Nationwide Claims Database.Therapeutics and clinical risk management · 2022Article
- Signals and Mechanisms Regulating Monocyte and Macrophage Activation in the Pathogenesis of Juvenile Idiopathic Arthritis.International journal of molecular sciences · 2021Review
- Advances in Juvenile Spondyloarthritis.Current rheumatology reports · 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
31 authors at 17 institutions in 9 countries.
Funding
Abstract
objectivesTo assess efficacy, pharmacokinetics (PK) and safety of intravenous (i.v.) golimumab in patients with polyarticular-course JIA (pc-JIA).
methodsChildren aged 2 to <18 years with active pc-JIA despite MTX therapy for ≥2 months received 80 mg/m2 golimumab at weeks 0, 4, then every 8 weeks through week 52 plus MTX weekly through week 28. The primary and major secondary endpoints were PK exposure and model-predicted steady-state area under the curve (AUCss) over an 8-week dosing interval at weeks 28 and 52, respectively. JIA ACR response and safety were also assessed.
resultsIn total, 127 children were treated with i.v. golimumab. JIA ACR 30, 50, 70, and 90 response rates were 84%, 80%, 70% and 47%, respectively, at week 28 and were maintained through week 52. Golimumab serum concentrations and AUCss were 0.40 µg/ml and 399 µg ⋅ day/ml at week 28. PK exposure was maintained at week 52. Steady-state trough golimumab concentrations and AUCss were consistent across age categories and comparable to i.v. golimumab dosed 2 mg/kg in adults with rheumatoid arthritis. Golimumab antibodies and neutralizing antibodies were detected via a highly sensitive drug-tolerant assay in 31% (39/125) and 19% (24/125) of patients, respectively. Median trough golimumab concentration was lower in antibody-positive vs antibody-negative patients. Serious infections were reported in 6% of patients, including one death due to septic shock.
conclusionBody surface area-based dosing of i.v. golimumab was well tolerated and provided adequate PK exposure for clinical efficacy in paediatric patients with active pc-JIA.ClinicalTrials.gov number NCT02277444.
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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.