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 | EUCTR2019-004101-27-NL (EUCTR) | 15/01/2020 | 12/12/2019 | Research into injecting golimumab less frequently by using increased doses | INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study’ - INDIGO | rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Level: LLT;Classification code 10037160;Term: Psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.1;Classification code 10071400;Term: Axial spondyloarthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Sint Maartenskliniek | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands | ||
| 2 | NCT01715896 (ClinicalTrials.gov) | March 2013 | 16/10/2012 | A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis | Rheumatoid Arthritis | Biological: Golimumab 50 mg;Biological: Mavrilimumab 100 mg | MedImmune LLC | NULL | Completed | 18 Years | 80 Years | All | 215 | Phase 2 | Argentina;Colombia;Czech Republic;France;Greece;Hungary;Israel;Mexico;Portugal;Russian Federation;Serbia;Slovakia;Spain;United Kingdom;Turkey |
| 3 | NCT01004432 (ClinicalTrials.gov) | December 2009 | 29/10/2009 | Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) | A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment With Etanercept (ENBREL) or Adalimumab (HUMIRA) | Arthritis;Arthritis, Rheumatoid;Autoimmune Diseases | Drug: Golimumab 50 mg SC;Drug: Golimumab 2 mg/kg IV;Drug: Methotrexate (MTX);Drug: Placebo SC;Drug: Placebo IV | Janssen Biotech, Inc. | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 433 | Phase 3 | United States;Austria;Belgium;Canada;Germany;Greece;Sweden;United Kingdom;France;Spain |
| 4 | NCT00299546 (ClinicalTrials.gov) | February 2006 | 3/3/2006 | A Study of the Safety and Efficacy of Golimumab (CNTO 148) in Subjects With Active Rheumatoid Arthritis Previously Treated With Biologic Anti-TNFa Agent(s) | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s) | Arthritis, Rheumatoid | Drug: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 461 | Phase 3 | United States;Australia;Austria;Canada;Finland;Germany;Netherlands;New Zealand;Spain;United Kingdom;France;Switzerland |
| 5 | NCT00264550 (ClinicalTrials.gov) | December 2005 | 11/12/2005 | An Efficacy and Safety Study of Golimumab in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Subjects With ActiveRheumatoid Arthritis Despite Methotrexate Therapy | Rheumatoid Arthritis | Drug: Golimumab 100 mg;Drug: Golimumab 50 mg;Drug: Methotrexate;Drug: Placebo injection;Drug: Placebo capsules | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 444 | Phase 3 | United States;Argentina;Australia;Canada;Chile;Germany;Hungary;Korea, Republic of;Mexico;New Zealand;Poland;Taiwan;Brazil;India;Turkey |
| 6 | NCT00264537 (ClinicalTrials.gov) | December 2005 | 11/12/2005 | A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive | A Multicenter, Randomized, Double-blind, Placebo-controlledTrial of Golimumab, a Fully Human Anti-TNFa MonoclonalAntibody, Administered Subcutaneously, in Methotrexate-naive Subjects With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Placebo injections;Drug: Placebo capsules;Drug: Methotrexate capsules;Biological: Golimumab 50 mg injections;Biological: Golimumab 100 mg injections | Centocor, Inc. | Schering-Plough | Completed | 18 Years | N/A | All | 637 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Chile;Hungary;India;Korea, Republic of;Malaysia;New Zealand;Philippines;Poland;Russian Federation;Singapore;Spain;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Mexico;Turkey |