EUCTR2019-001996-35-SK进行中（未招募）1 期
PENGUIN 1: A Phase 3, Randomized, Double-blind, Placebo and Adalimumab-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects with Active Psoriatic Arthritis Who Are Naïve to Biologic DMARD Therapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 854
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this
- •Male or female subjects who are 18-75 years of age (19-75 years of age at sites in Republic of Korea. 20-75 years of age at sites in Japan and Taiwan), on the day of signing initial informed consent
- •Meet Classification Criteria for Psoriatic Arthritis (CASPAR) and have a history consistent with PsA =6 months at Screening
- •Have active PsA defined as =3 swollen joints (from a 66 swollen joint count [SJC]) and =3 tender joints (from a 68 tender joint count [TJC]) at Screening and Day 1;these may or may not be the same joints at Screening and Day 1
- •Must have a documented history or active signs of at least one of the following at Screening:
- •Plaque psoriasis or nail changes attributed to psoriasis
- •Have had inadequate response or intolerance to =1 csDMARD, apremilast and / or NSAID, administered over the course of =12 weeks for the treatment of PsA, as per local guidelines / standard of care
- •If continuing csDMARD(s) during the study, subjects are permitted to use only a maximum of 2 of the drugs as outlined in Section 4.2 of the Protocol and must have been on this treatment for =12 consecutive weeks prior to Screening, with a stable dose and route of administration (defined as no change in prescription) for =4 weeks prior to Day 1
- •Concomitant NSAIDs or corticosteroids are permitted as specified in Sections 4.2 and 4.3 of the Protocol
- •Meet one of the TB screening criteria as described in Section 4.2 of the Protocol.
- •Able and willing to sign the informed consent as approved by the IRB/IEC
- •Able and willing to perform SC self-injections or have a caregiver able, willing, and available to administer the injections
- •Subjects receiving non-prohibited medication for any reason should be on a stable dose prior to the first administration of the study drug on day 1
- •A negative serum pregnancy test result at the Screening Visit and negative urine pregnancy test result at the Day 1 Visit are required for female subjects of child bearing potential
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Lactating females must agree to discontinue nursing before the study drug is administered
- •MRI Inclusion Criteria
- •Subject must fulfill criteria for entry to the Main Study
- •Subject must have PsA joint involvement at a minimum in one hand / wrist as confirmed by the investigator at Screening. The same hand / wrist (R or L) should be imaged at all subsequent MRIs, regardless of PsA activity
- •Subject’s baseline MRI must fulfill at least one of the following criteria by central reading: Definitive intra-articular MRI synovitis (PsAMRIS Grade =2 in any applicable hand or wrist joint, or PsAMRIS Grade 1 in =2 applicable joints); or definitive MRI osteitis in any applicable bone
- •An acceptable baseline MRI read and approved by central imaging, on or before day 28 of Screening
- •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 598
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 256
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
- •Known hypersensitivity to the study drug, the metabolites or the formulation excipients
- •Prior PsA or psoriasis treatment with a bioDMARD
- •Prior exposure to a JAK inhibitor >2 doses
- •Any active / recent infection, as specified in Section 4.3 of the Protocol
- •Any chronic and / or uncontrolled medical condition that would put the subject at increased risk during study participation or circumstances which may make a subject unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement
- •Any moderately to severely active musculoskeletal or skin disorder other than PsA or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of the investigator NOTE: Prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to PsA or additional diagnosis of PsA
- •Any history of an inflammatory arthropathy with onset before age 16 years old
- •Active autoimmune disease that would interfere with assessment of study parameters or increase risk to the subject by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator
- •Presence of any extra-articular manifestations typically associated with rheumatoid arthritis (RA), such as rheumatoid nodules, rheumatoid lung, or other signs / symptoms, as per judgement of investigator
- •Pregnancy or nursing females
- •Active drug or alcohol abuse, as per judgement of investigator
- •Unwilling or unable to follow protocol requirements
- •Key MRI Exclusion Criteria
- •NOTE: Subject may still participate in the Main Study / LTE if ineligible for the MRI investigation. Reasons for ineligibility may include, but are not limited to:
- •Inability or medical contraindication for an MRI examination (e.g. presence of a pacemaker, defibrillator, or other contraindicated implanted metallic device, such as anterior interbody cages, aneurysm clip or pedicle screws, severe claustrophobia or weight >350 lbs or >158kg.))
- •Metallic fragments embedded anywhere in the body OR pigment-containing tattoos in the area of examination
- •Known or potential risk of adverse reaction to gadolinium-base contrast agents, including but not limited to, allergy or compromised renal function, per investigator judgement
- •Very difficult peripheral intravascular access
- •Site or region was not selected by Sponsor to perform MRIs
研究者
相似试验
已完成
不适用
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis (IMAGE)-M069M069PER-007-07F. HOFFMANN-LA ROCHE LTD.,35
进行中（未招募）
1 期
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia(VALOR) - VALOREUCTR2010-021961-61-ITSUNESIS PHARMACEUTICALS, INC.750
进行中（未招募）
不适用
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 years with Moderate to Severe Chronic Kidney Disease. Estudio en fase 3 prospectivo, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la farmacocinética,la seguridad y la eficacia de paricalcitol cápsulas en cuanto a la reducción de la concentración sérica de hormona paratiroidea intacta en niños y adolescentes de entre 10 y 16 años connefropatía crónica moderada o grave. - N/AModerar la Nefropatía Crónica GraveModerate to Severe Chronic Kidney DiseaseMedDRA version: 12.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseEUCTR2010-019439-37-ESAbbott GmbH & Co. KG72
进行中（未招募）
不适用
Safety and Efficacy of Paricalcitol Capsules in decreasing serum parathyroid hormone levels in children 10-16 with Chronic Kidney Disease (CKD)Moderate to Severe Chronic Kidney DiseaseMedDRA version: 17.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857EUCTR2010-019439-37-PTAbbVie Deutschland GmbH & Co. KG36
进行中（未招募）
不适用
Safety and Efficacy of Paricalcitol Capsules in decreasing serum parathyroid hormone levels in children 10-16 with Chronic Kidney Disease (CKD)Moderate to Severe Chronic Kidney DiseaseMedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857EUCTR2010-019439-37-DEAbbVie Deutschland GmbH & Co. KG36