治験一覧
8,963 件中 4721〜4740 件を表示
日本の臨床現場における生物学的製剤未治療関節リウマチ患者におけるアバタセプトの長期転帰
The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.
非放射線学的軸性脊椎関節炎患者におけるセクキヌマブの有効性および安全性に関する研究
The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208
メソテリン-ADCの第1相試験
The purpose of this study is to assess the safety and tolerability of Mesothelin-ADC in subjects with advanced and/or metastatic solid tumors.
健康な日本人被験者を対象としたGSK2315698の第1相臨床試験
This is the first study in which GSK2315698 will be administered in Japanese population. The primary objective of the study is to investigate safety and tolerability, pharmacokinetics, and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a single center, double-blind, randomized, placebo-controlled, dose-ascending study. Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3 groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be separated by a washout period of at least 8 and 10 days, respectively. Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours. A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort) complete the study. The duration of participation for any subject in this study will be approximately 59 days.
女性患者におけるイリボウの特別な薬物使用監視
The purpose of the survey is to evaluate the safety and efficacy of Irribow and Irribow OD Tablets in post-marketing medical practice and to examine the status of treatment compliance.
周期性発熱症候群を有する日本人患者におけるカナキヌマブの安全性に関する延長試験
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301 (NCT02059291) study to continue to be treated with ACZ885 until approval in Japan of the drug in Periodic Fever Syndromes or until development of ACZ885 in Periodic Fever Syndromes was suspended.
慢性腎臓病に伴う貧血を有する日本人血液透析患者（赤血球生成刺激剤を服用していない患者）におけるGSK1278863の有効性および安全性に関する研究
This 24-week, Phase 3, open-label, non-comparative, multicentre study aims to evaluate the efficacy and safety of GSK1278863 in Japanese hemodialysis (HD) patients with renal anemia not using erythropoiesis-stimulating agents (ESAs). The primary objective is to evaluate the initial response to GSK1278863 measured by hemoglobin (Hgb) levels in HD patients not using ESAs enrolled in this study. The study is designed to evaluate the appropriateness of the starting dose of GSK1278863 and of the GSK1278863 dose adjustment regimen to achieve or maintain the target Hgb levels. This study will consist of a 4-week screening period, a 24-week treatment period (4-week fixed-dose period and a 20-week dose adjustment period), and a 2- to 4-week follow-up period.
BI-RADS® 3および4病変の評価における仮想タッチ組織画像定量化（VTIQ - 2D-SWE）の評価
The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).
固形腫瘍患者を対象としたLY3200882の研究
The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.
メトトレキサート（MTX）に対する反応が不十分な成人関節リウマチ（RA）患者を対象とした、ウパダシチニブ（ABT-494）単剤療法とメトトレキサート（MTX）単剤療法を比較する研究（SELECT-MONOTHERAPY）
The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.
中等度から重度の潰瘍性大腸炎患者を対象としたミリキズマブ（LY3074828）の臨床試験
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.
進行固形腫瘍を有する日本人患者を対象としたLY3039478の研究
The purpose of this study is to evaluate the tolerability of the study drug LY3039478 in Japanese participants with advanced solid tumors.
タネズマブ試験の被験者のうち、膝、股関節、または肩の人工関節置換術を受けた被験者を対象とした長期観察研究
A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).
NRG1融合遺伝子（eNRGy）を有する固形腫瘍患者におけるゼノクツズマブ（MCLA-128）の研究
This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)
PRI-724-1101の追跡評価研究
The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.
DMD患者におけるドリサペルセンの延長試験
This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.
MAPK経路異常を有する進行性固形腫瘍患者を対象としたLXH254の第I相試験
A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.
活動性ループス腎炎患者におけるBI 655064の用量設定、有効性および安全性
The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.
転移性結腸直腸癌の成人患者を対象とした、FOLFIRI + ベバシズマブ併用BBI608投与に関する研究
This is an open-label, multicenter, phase 1 study of BBI608 in combination with FOLFIRI + Bavacizumab. This study population is adult Japanese patients with metastatic colorectal cancers in FOLFIRI + Bevacizumab combination therapy.
超音波ガイド下大腿静脈アクセス性、安全性、および心房細動治療にかかる時間
This study is designed to evaluate the use of real-time ultrasound-guided femoral venipuncture during pulmonary vein isolation for treating atrial fibrillation .