EUCTR2013-003554-25-GB进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects with Psoriatic Arthritis: AMVISION-1 - AMVISION-1
Amgen Inc.0 个研究点目标入组 630 人开始时间: 2014年2月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 630
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subject has provided informed consent
- •- Subject is = 18 years of age at time of screening
- •- Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria
- •- Subject has = 3 tender and = 3 swollen joints
- •- Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Other Medical Conditions:
- •- Subject has any systemic disease (eg, renal failure, heart failure, hypertension, liver disease, diabetes, anemia) considered by the investigator to be clinically significant and uncontrolled.
- •- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
- •Washouts or Other Treatments
- •- Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows:
- •? anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation
- •? other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation
- •? anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time
- •? rituximab at any time
- •- Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening.
- •- Other investigational procedures while participating in this study are excluded.
- •- Subject has known sensitivity to any of the products or components to be administered during dosing.
- •-Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia Suicide Severity Rating Scale (eC-SSRS) at screening or at baseline
- •-Subject has a history or evidence of a psychiatric disorder or substance abuse that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- •-Subject has severe depression based on a total score of = 15 on the Patient Health Questionnaire-8 (PHQ-8) at screening or baseline (note: subjects with a total score of 10-14 on the PHQ-8 should referred to a mental health professional).
- •- Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug.
- •- Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
研究者
相似试验
进行中（未招募）
1 期
A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 TreatmentMedDRA version: 20.0Level: LLTClassification code 10001624Term: Alcoholic hepatitisSystem Organ Class: 100000004871Alcoholic hepatitisEUCTR2020-004534-38-DEDURECT Corporation300
进行中（未招募）
不适用
A Clinical Trial Investigating OSI-906 in Patients with Adrenocortical CarcinomaAdrenocortical CarcinomaMedDRA version: 14.1Level: PTClassification code 10001388Term: Adrenocortical carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-012820-97-DEAstellas Pharma Global Development, Inc.135
招募中
3 期
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Metastatic Breast CancerBreast carcinoma10006291Breast cancerNL-OMON51870Merck Sharp & Dohme (MSD)24
进行中（未招募）
不适用
A study of AMG 416 in the treatment of secondary hyperparathyroidism in chronic kidney diseaseSecondary hyperparathyroidism in subjects with chronic kidney diseaseMedDRA version: 17.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 17.0Level: LLTClassification code 10020706Term: Hyperparathyroidism NOSSystem Organ Class: 10014698 - Endocrine disordersEUCTR2012-002805-23-ATKAI Pharmaceuticals, Inc (a subsidiary of Amgen, Inc.)500
进行中（未招募）
1 期
A phase 3 randomised, double-blind, placebo-controlled efficacy and safety study funded by Furiex Pharmaceuticals. The purpose of this study is to find out if a new investigational drug called JNJ-27018966 is safe and effective as a treatment for diarrhea-predominant Irritable Bowel Syndrome (IBS-d).Diarrhea-predominant irritable bowel syndromeMedDRA version: 20.1 Level: LLT Classification code 10060845 Term: Diarrhea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersMedDRA version: 20.1 Level: PT Classification code 10023003 Term: Irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disordersEUCTR2012-001600-38-GBFuriex Pharmaceuticals1,282