EUCTR2017-003978-13-GR进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis: Select-GCA
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
- 420
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
- •1. Diagnosis of GCA according to the following criteria:
- •Adult male or female, at least 50 years of age
- •History of ESR = 50 mm/hour or hsCRP/CRP = 1.0 mg/dL
- •Presence of at least one of the following:
- •Unequivocal cranial symptoms of GCA, OR
- •Unequivocal symptoms of PMR
- •Presence of at least one of the following:
- •Temporal artery biopsy revealing features of GCA, OR
- •Evidence of large vessel vasculitis by angiography or cross-sectional imaging (such as magnetic resonance imaging [MRI], computed tomography [CT] or positron emission tomography [PET]) assessed by a qualified radiologist experienced in evaluating large vessel vasculitis, or ultrasound of temporal arteries assessed by a qualified physician experienced in evaluating large vessel vasculitis.
- •2. Active GCA, either new onset or relapsing, within 8 weeks of study start.
- •3. Has received treatment with = 40 mg prednisone (or equivalent) at any time prior to study start and be receiving prednisone (or prednisolone) = 20 mg QD at study start.
- •4. Has GCA that is clinically stable.
- •5. Females must either be postmenopausal or permanently surgically sterile or, practicing at least 1 specified method of birth control through the study.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 252
排除标准
- •Exclusion Criteria:
- •1. Prior exposure to any JAK inhibitor
- •2. Treatment with an interleukin-6 (IL-6) inhibitor within 4 weeks of study start, or prior treatment with an IL-6 inhibitor and experienced a disease flare during treatment.
- •3. Subject must not have received a biologic or non-biologic DMARD within at least five times the mean terminal elimination half-life of the drug, or must follow the washout period specified in the protocol
- •4. Current or past history of infection including herpes zoster or herpes simplex, HIV, active Tuberculosis, active or chronic recurring infection, active hepatitis B or C.
- •5. Female who is pregnant, breastfeeding, or considering pregnancy during the study
研究者
相似试验
进行中（未招募）
1 期
A study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic TherapyCrohn's Disease (CD)MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2017-001226-18-CZAbbVie Deutschland GmbH & Co. KG645
进行中（未招募）
1 期
A study to test the efficacy and safety of padsevonil as treatment of focal-onset seizures in adult subjects with drug-resistant epilepsyFocal-Onset SeizuresMedDRA version: 21.1Level: LLTClassification code 10065337Term: Focal epilepsySystem Organ Class: 100000004852EUCTR2018-002303-33-BECB Biopharma SR625
招募中
3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate CancerNon-Metastatic Castration-Resistant Prostate Cancernon-spread Castration-Resistant Prostate Cancer10036958NL-OMON54510Aragon Pharmaceuticals, Inc.35
进行中（未招募）
1 期
A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseEUCTR2019-002531-29-GBVisterra, Inc.144
进行中（未招募）
不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin, Alone.Type 2 Diabetes MellitusEUCTR2009-010224-25-HUBristol-Myers Squibb International Corporation152