Trial reportAnnals of the rheumatic diseases2013
Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks.
Trial report in Annals of the rheumatic diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00771251 (A Study of Golimumab), which is not on this map. Cited by 22 papers, 6 of them syntheses that pooled it.
What it found
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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 Study of Golimumab (CNTO148) Monotherapy in Patients With Active Rheumatoid Arthritis
Who cites it
22 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Pooled it
- The Risk of Adverse Effects of TNF-α Inhibitors in Patients With Rheumatoid Arthritis: A Network Meta-Analysis.Frontiers in immunology · 2022Pooled it
- Radiographic progression in clinical trials in rheumatoid arthritis: a systemic literature review of trials performed by industry.RMD open · 2020Pooled it
- Biologics or tofacitinib for people with rheumatoid arthritis unsuccessfully treated with biologics: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- Biologic or tofacitinib monotherapy for rheumatoid arthritis in people with traditional disease-modifying anti-rheumatic drug (DMARD) failure: a Cochrane Systematic Review and network meta-analysis (NMA).The Cochrane database of systematic reviews · 2016Pooled it
- Biologics or tofacitinib for rheumatoid arthritis in incomplete responders to methotrexate or other traditional disease-modifying anti-rheumatic drugs: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2016Pooled it
- Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients.Arthritis research & therapy · 2018Trial
- Effect of Ozoralizumab Administration with or without Methotrexate in Patients with Rheumatoid Arthritis: A Post-Hoc Analysis.Rheumatology and therapy · 2025Article
- Long-term Use of Golimumab in Daily Practice for Patients with Rheumatoid Arthritis.Internal medicine (Tokyo, Japan) · 2021Article
- Effect of Golimumab Dose Escalation in Japanese Patients With Rheumatoid Arthritis: Post-Hoc Analysis of Post-Marketing Surveillance Data.Rheumatology and therapy · 2020Article
- Different Original and Biosimilar TNF Inhibitors Similarly Reduce Joint Destruction in Rheumatoid Arthritis-A Network Meta-Analysis of 36 Randomized Controlled Trials.International journal of molecular sciences · 2019Review
- Safety, Effectiveness, and Treatment Persistence of Golimumab in Elderly Patients with Rheumatoid Arthritis in Real-World Clinical Practice in Japan.Rheumatology and therapy · 2018Article
- Real-World Treatment Patterns for Golimumab and Concomitant Medications in Japanese Rheumatoid Arthritis Patients.Rheumatology and therapy · 2018Article
- Early phase and adaptive design clinical trials in rheumatoid arthritis: a systematic review of early phase trials.Rheumatology advances in practice · 2018Article
- Risk of Herpes Zoster in Individuals on Biologics, Disease-Modifying Antirheumatic Drugs, and/or Corticosteroids for Autoimmune Diseases: A Systematic Review and Meta-Analysis.Open forum infectious diseases · 2016Article
- Combination therapy with biologic agents in rheumatic diseases: current and future prospects.Therapeutic advances in musculoskeletal disease · 2016Review
- The 2 + 1 paradigm: an efficient algorithm for central reading of Mayo endoscopic subscores in global multicenter phase 3 ulcerative colitis clinical trials.Gastroenterology report · 2016Article
- Pharmacokinetics, efficacy and safety profiles of etanercept monotherapy in Japanese patients with rheumatoid arthritis: review of seven clinical trials.Modern rheumatology · 2015Review
- Predictive factors related to the efficacy of golimumab in patients with rheumatoid arthritis.Clinical medicine insights. Arthritis and musculoskeletal disorders · 2015Article
- Adverse reactions to biologic agents and their medical management.Nature reviews. Rheumatology · 2014Review
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs).
methodsA total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study.
resultsDemographics were similar across groups; the mean age was 52 years and 81.8% of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 (20/105 (19.0%); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8% of patients in group 1, 62.4% in group 2 and 60.8% in group 3 had AEs and 1.9%, 1.0% and 2.0% had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24.
conclusionsGolimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.
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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.