NL-OMON45740已完成3 期
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate - GS-US-417-0301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •For a complete list of study inclusion criteria, please refer to Section 4.2 of the study protocol.;Main Eligibility Criteria
- •1) Male or female subjects who are *18 years of age, on the day of signing informed consent.
- •2) Have a diagnosis of RA (2010 ACR/EULAR criteria) , and are ACR functional class I-III.
- •3) Have *6 swollen joints (from a SJC66) and *6 tender joints (from a TJC68) at both Screening and Day 1.
- •4) Must meet at least one of the following parameters at Screening:
- •a) *1 documented joint erosion on radiographs of the hands, wrists or feet by central reading AND a positive result for anti-CCP or RF at the central laboratory,
- •OR b) *3 documented erosions on radiographs of the hands, wrists or feet by central reading if both antibodies (ie, RF, anti-CCP) are negative (based on central laboratory),
- •OR c) Serum CRP * 6 mg/L based on central laboratory value
- •5) Ongoing treatment with a stable dose of MTX as described below:
- •a) Use of oral MTX on a continuous basis for at least 12 weeks prior to Day 1 and on a stably prescribed dose of 7.5-25 mg/weekly for at least 4 weeks prior to Day 1. Stable doses of <7.5 mg/week are allowed only in the presence of intolerance or toxicity to higher doses or where higher doses are prohibited by the local label or local clinical practice. Doses >25 mg weekly are not permitted during the study.
- •b) Subjects should be receiving an adequate and prescribed stable dose of folic acid (*5 mg/week total dose or as per local clinical practice) which should be confirmed or initiated at Screening,
- •and continued throughout the study.
- •c) Subjects may use concomitant hydroxychloroquine (HCQ) *400 mg/day or chloroquine *250 mg/day during the study with the prescription having been stable for at least 4 weeks prior to Day 1.
排除标准
- •For a complete list of study exclusion criteria, please refer to section 4.3 of the study protocol:
- •Subjects that have failed prior therapy with a bDMARD are not eligible to participate. Subjects with prior exposure to one bDMARD may be enrolled (approximately 20% of total study population) if there is documented evidence of limited exposure (ie, less than 3 months) to the bDMARD
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant paiModerate to severe chronic pain of low back that requires around-the-clock opioid therapy.MedDRA version: 7.0Level: ptClassification code 10003988EUCTR2004-003752-19-ATMundipharma Research GmbH & Co.KG750
进行中（未招募）
不适用
A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant paiModerate to severe chronic pain of low back that requires around-the-clock opioid therapy.MedDRA version: 7.0Level: ptClassification code 10003988EUCTR2004-003752-19-CZMundipharma Research GmbH & Co.KG950
进行中（未招募）
3 期
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateCTRI/2017/08/009478Gilead Sciences Inc
进行中（未招募）
1 期
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to MethotrexateEUCTR2016-000568-41-NLGilead Sciences, Inc.1,759
进行中（未招募）
1 期
A Randomized, Double-blind, Placebo- and Active-controlled, Double-dummy, Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged-release Tablets in Subjects with Moderate to Severe, Chronic Nonmalignant Pain - OXN in moderate to severe, chronic nonmalignant paiModerate to severe chronic pain of low back that requires around-the-clock opioid therapy.MedDRA version: 7.0Level: ptClassification code 10003988EUCTR2004-003752-19-SKMundipharma Research GmbH & Co.KG950