Trial reportArthritis research & therapy2013
A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis.
Trial report in Arthritis research & therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00771030 (A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis), which is not on this map. Cited by 50 papers, 5 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, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis
Who cites it
50 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Risk for development of inflammatory bowel disease under inhibition of interleukin 17: A systematic review and meta-analysis.PloS one · 2020Pooled it
- Risk of Infections and Cancer in Patients With Rheumatologic Diseases Receiving Interleukin Inhibitors: A Systematic Review and Meta-analysis.JAMA network open · 2019Pooled it
- Meta-analysis of IL-17 inhibitors in two populations of rheumatoid arthritis patients: biologic-naïve or tumor necrosis factor inhibitor inadequate responders.Clinical rheumatology · 2019Pooled it
- Safety and Efficacy of Brodalumab for Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis.Clinical drug investigation · 2017Pooled it
- Anti-IL-17 therapy in treatment of rheumatoid arthritis: a systematic literature review and meta-analysis of randomized controlled trials.Rheumatology international · 2016Pooled it
- A randomised phase II study evaluating the efficacy and safety of subcutaneously administered ustekinumab and guselkumab in patients with active rheumatoid arthritis despite treatment with methotrexate.Annals of the rheumatic diseases · 2017Trial
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- Impact of Biological Therapies on Quality of Life in Rheumatoid Arthritis: A Narrative Review.Open access rheumatology : research and reviews · 2025Review
- Liposomes: An Emerging Strategy for the Effective Treatment of Rheumatoid Arthritis.Current rheumatology reviews · 2025Review
- The IL-17 family in diseases: from bench to bedside.Signal transduction and targeted therapy · 2023Review
- Identification of biomarkers in patients with rheumatoid arthritis responsive to DMARDs but with progressive bone erosion.Frontiers in immunology · 2023Article
- Pharmacogenomics of Monoclonal Antibodies for the Treatment of Rheumatoid Arthritis.Journal of personalized medicine · 2022Review
- Interleukin-17 contributes to Ross River virus-induced arthritis and myositis.PLoS pathogens · 2022Article
- Interleukin-17 as a potential therapeutic target for chronic pain.Frontiers in immunology · 2022Review
- Mesenchymal Stem Cell-Based Therapy for Rheumatoid Arthritis.International journal of molecular sciences · 2021Review
- Cytokine Networks in the Pathogenesis of Rheumatoid Arthritis.International journal of molecular sciences · 2021Review
- Reactivation of latent tuberculosis with TNF inhibitors: critical role of the beta 2 chain of the IL-12 receptor.Cellular & molecular immunology · 2021Review
- Transcriptional Interactomic Inhibition of RORα Suppresses Th17-Related Inflammation.Journal of inflammation research · 2021Article
- Distinct roles of interleukin-17 and T helper 17 cells among autoimmune diseases.Journal of translational autoimmunity · 2021Article
- Role of the IL-23/IL-17 Pathway in Rheumatic Diseases: An Overview.Frontiers in immunology · 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
13 authors.
Funding
Abstract
introductionThe aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA).
methodsThis phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥ 6/66 swollen and ≥ 8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics.
resultsForty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70.
conclusionsMultiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA.
trial registrationClinicalTrials.gov, NCT00771030.
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.