EUCTR2016-000615-33-DE进行中（未招募）1 期
Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis: a randomized controlled multicentre trial (CONSUL) - CONS
Charite Universitaetsmedizin0 个研究点目标入组 170 人开始时间: 2016年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 170
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.Age =18 years.
- •2.Definite diagnosis of AS according to the modified New York criteria1.
- •3.History of an inadequate response to =2 NSAIDs taken for at least 2 weeks each.
- •4.Active disease as defined by a BASDAI value of =4 at screening and baseline.
- •5.Presence of at least one of the following risk factors for radiographic spinal progression:
- •Elevated CRP (>5mg/l) at screening at the absence of reasons for elevated CRP other than AS;
- •Presence of = 1 syndesmophyte on prior X-rays of the spine.
- •6.Subject is a candidate for anti-TNF therapy based on the investigator’s opinion.
- •7.Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.
- •8.If female: either unable to bear children or is willing and able to practice a reliable method of contraception throughout the study and 6 months after the last dose of study drug
- •9.If on NSAIDs: the dose must be stable for at least 2 weeks prior to baseline.
- •10.If on oral steroids: the dose must not exceed 10 mg (prednisolone equivalent) per day and must be stable for at least 2 weeks prior to baseline.
- •11.If on methotrexate: the dose must not exceed 25 mg per week and must be stable for at least 4 weeks prior to baseline.
- •12.If on sulfasalazine: the dose must not exceed 3 g per day and must be stable for at least 4 weeks prior to baseline.
- •13.If on analgesics: the dose must be stable for at least 2 weeks prior to baseline.
- •Phase II of the study:
- •1.Achievement of at least 50% improvement or >=2 absolute points (on a 0-10 scale) reduction of the BASDAI after 12 weeks of Golimumab treatment in the Phase I.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- for female subjects: pregnancy or lactating.
- •- subjects with chronic inflammatory articular disease other than SpA or systemic autoimmune disease.
- •- history of inadequate response (primary non-response) to previous anti-TNF therapy.
- •- treatment with any other investigational drug within 3 months of 5 half-lifes of the drug (whichever is longer) prior to Baseline visit.
- •- history of intolerability or hypersensitivity reaction study drugs
- •- any active current infection. History of recurrent clinically significant infection (suggestive for primary or secondary immunodeficiency). Infections requiring treatment with antibiotics within 4 weeks prior to baseline.
- •- current clinical signs and symptoms suggestive for tuberculosis.
- •- positive QuantiFERON®-TB Gold In-Tube test at screening and/or abnormal chest x-ray (performed at screening or within 3 months prior to screening) suggestive for past or present tuberculosis (positive x-ray). Patients with a positive QuantiFERON®-TB Gold In-Tube test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic anti-tuberculous treatment.
- •- chronic infection with hepatitis B or C, history of HIV infection.
- •- malignancies
- •- demyelinating disease (like multiple sclerosis; including myelitis)
- •- history of cardiovascular events or high cardiovascular risk
- •- history of GI ulceration or any clinically relevant GI bleeding, perforation, or gastric outlet obstruction.
- •- History of a chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
- •- evidence of other severe uncontrolled disorders.
- •- diagnosis of fibromyalgia.
- •- several abnormalities of laboratory values as defined in the protocol
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