EUCTR2017-003065-95-GB进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
CB Biopharma SR0 个研究点目标入组 300 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •-Subject has ankylosing spondylitis as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years
- •-Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
- •-Subjects had to have either failed to respond to 2 different nonsteroidal
- •anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose
- •for a total of 4 weeks or have a history of intolerance to or a
- •contraindication 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 288
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •-Total ankylosis of the spine
- •-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 at any time are excluded
- •-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 ankylosing spondylitis
- •(AS), 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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