46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,325 / 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04333147 (ClinicalTrials.gov) | May 12, 2020 | 27/3/2020 | Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) | A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis | Arthritis, Rheumatoid | Biological: Otilimab (GSK3196165);Drug: csDMARD(s) | GlaxoSmithKline | Iqvia Pty Ltd | Recruiting | 18 Years | N/A | All | 3000 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Colombia;Czechia;Estonia;Germany;Hungary;India;Japan;Korea, Republic of;Latvia;Lithuania;Poland;Russian Federation;South Africa;Spain;Ukraine;United Kingdom |
| 2 | NCT04134728 (ClinicalTrials.gov) | October 31, 2019 | 18/10/2019 | Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors | A 24-week, Phase 3, Multicentre, Randomised, Double-blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Sarilumab, in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological DMARDs and/or Janus Kinase Inhibitors | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Biological: Sarilumab;Drug: Placebo to GSK3196165/ Sarilumab;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Completed | 18 Years | N/A | All | 550 | Phase 3 | United States;Argentina;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Lithuania;Poland;South Africa;Spain;United Kingdom |
| 3 | NCT03970837 (ClinicalTrials.gov) | June 5, 2019 | 16/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic (cs)/Biologic (b) Disease Modifying Anti-rheumatic Drugs (DMARDs) | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs | Arthritis, Rheumatoid | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib;Drug: Placebo to GSK3196165 (Otilimab);Drug: Placebo to Tofacitinib;Drug: csDMARDs | GlaxoSmithKline | Iqvia Pty Ltd | Active, not recruiting | 18 Years | N/A | All | 1764 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;China;Colombia;Estonia;France;Germany;Hungary;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Thailand;United Kingdom |
| 4 | NCT03980483 (ClinicalTrials.gov) | May 16, 2019 | 15/5/2019 | Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate | Arthritis, Rheumatoid;Glycogen Storage Disease Type II | Biological: GSK3196165 (Otilimab);Drug: Tofacitinib 5 mg;Drug: Placebo to GSK3196165;Drug: Placebo to tofacitinib;Drug: Methotrexate;Drug: Folic (or folinic) acid | GlaxoSmithKline | Iqvia Pty Ltd | Active, not recruiting | 18 Years | N/A | All | 1537 | Phase 3 | United States;Argentina;Canada;China;Czechia;Hungary;India;Italy;Latvia;Lithuania;Malaysia;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;United Kingdom |