EUCTR2017-003064-13-BG进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THEEFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
CB Biopharma SR0 个研究点目标入组 240 人开始时间: 2019年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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
- •-Male or female patients at least 18 years of age
- •-Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria:
- •a) Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria
- •b) Inflammatory back pain for at least 3 months
- •c) Age at symptom onset of less than 45 years.
- •d) NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray)
- •-Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
- •-Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein.
- •-Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSDIDs) given at the maximum tolerated dose for a total 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
- •-Patients must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) to NSAID therapy
- •-Patients who have taken a tumor necrosis factor alpha (TNFa) inhibitor must have experienced
- •an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
- •-Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast
- •can be allowed if they fulfill specific requirements prior to study entry
- •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 237
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •-Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa biological response modifiers, or any interleukin (IL)-17 biological response modifier
- •-Active infection or history of recent serious infections
- •-Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •-Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
- •-Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
- •-Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
- •-Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn’s disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
- •-Presence of active suicidal ideation, or moderately severe major depression or severe major depression
- •-Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
- •-Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening
研究者
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