EUCTR2017-001728-23-BE进行中（未招募）1 期
Efficacy of golimumab in early axial spondyloarthritis (axSpA) in relation to gut inflammation, an early remission induction study (GO GUT). - GO GUT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 147
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 must have a diagnosis of axSpA and classified according to ASAS criteria.
- •-Subject is between 18 and 46 years at the screening visit.
- •-Subject has at least 3 months and maximum 1 year (almost) daily chronic back pain.
- •-Subject has an active disease defined as a positive MRI (according to ASAS definition) or elevated CRP (in patients who are HLA-B27+) and an ASDAS score > 2.1 (at least high disease activity).
- •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 147
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Full anti-inflammatory dose of NSAIDs for more than 4 weeks for the duration of the axSpA symptoms.
- •-Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy.
- •-Exposure to disease-modifying drugs (DMARDSs; i.e. methotrexate and sulfasalazine) in the last 3 months before the ileocolonoscopy.
- •-Exposure to systemic corticosteroid treatment in the last 14 days before the ileocolonoscopy.
- •-Infection(s) requiring treatment with intravenous antibiotics/antivirals/antifungals within 30 days prior to the baseline visit or oral antibiotics/antivirals/antifungals within 14 days prior to the baseline visit.
- •-Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab.
- •-History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease.
- •-History of listeriosis, histoplasmosis, chronic of active hepatitis B infection, hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis.
- •-Have a history of, or concurrent, chronic heart failure, including medically controlled, asymptomatic congestive heart failure.
- •-Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- •-Have received, or are expected to receive, any live virus or bacterial vaccination within 3 months prior to the first administration of study agent, during the trial, or within 6 months after the last administration of study agent.
- •-Positive pregnancy test at screening
- •-Female subjects who are breast-feeding or considering becoming pregnant during the study.
- •-Female subjects who do not use contraceptives.
- •-History of clinically significant drug or alcohol abuse in the last 12 months.
- •-Clinically significant abnormal screening laboratory results as evaluated by the investigator.
- •-Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of the normal.
- •-Subject with diagnosis and current symptoms of fibromyalgia.
- •-Any medical or psychological condition that, in the opinion of the investigator, could jeopardize or compromise the subject’s ability to participate in this study.
研究者
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