EUCTR2017-004226-15-DK进行中（未招募）1 期
CAN-ARTThe efficacy and safety of using cannabis derivatives cannabidiol (CBD) and tetrahydrocannabinol (THC)for the treatment of pain in patients with inflammatory arthritis (RA, AS).A randomized, double blinded, placebo controlled trial - Can-Art
King Christian 10th Hospital for Rheumatology0 个研究点目标入组 180 人开始时间: 2018年1月5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
- 180
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
- •Participants are patients diagnosed with seropositive RA, more specifically inflammatory well-treated patients, characterized by absence of arthritis at 40 counts and normal C-reactive protein (CRP) or with diagnosis AS in accordance with the modified New York criteria, i.e. based on physiotherapy and / or non-steroidal anti-inflammatory drugs (NSAIDs) and / or bDMARD inflammatory well-treated patients, characterized by absence of axial and peripheral arthritis as well as clinically detectable entesitis, as assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS < 2.1) and where normally CRP is documented.
- •Participant with the above mentioned diagnoses and relevant clinical status quo, followed regularly at one of the four departments are invited to participate in the study. Furthermore:
- •a.Receiving treatment on an outpatient basis
- •b.Diagnosed for at least 2 years
- •c.seropositive (anti CCP and/ or IgM RF) RA, radiology (MRI and/ or conventional X-ray) verified AS
- •d.RA: a stable inflammatory treatment situation achieved by ongoing cDMARD and / or bDMARD, 40 joint count without joint swelling
- •e.AS: a stable inflammatory treatment situation achieved by ongoing physiotherapy, NSAID, cDMARD and / or bDMARD: ASDAS < 2.1 for at least 4 weeks
- •f.Ongoing or earlier attempt of treatment with Paracetamol or NSAIDs with the outcome of parameters as mentioned in item e. or f.
- •g.Pain relief treatment unchanged at least 4 weeks before trial start
- •h.Minimum Pain VAS 50
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •a.Age < 18 years
- •b.Pregnancy or desiring pregnancy, ongoing breastfeeding
- •c.CRP > 10 mg/L
- •d.Swollen Joints
- •e.Comorbidities, more specific competitive rheumatologic disorders such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleroderma or polymyositis, chronic pain condition based on a further etiology (e.g. fibromyalgia)
- •f.Severe competing cardiovascular, pneumological, neurological, endocrinological, gastro-enterological, urogenital or nephrological disorder
- •g.Major surgery performed <8 weeks before randomization or planned major surgical interventions
- •h.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids.
- •i.Verified cancer
- •j.Known actual or previous alcohol or drug abuse
- •k. Ongoing treatment with opiods and / or cannabis products and / or neuroleptics, or treatment terminated less than 4 weeks before trial start
- •l. Known hypersensitivity to the study compounds
- •m. Suspected or known schizophrenia or other psychotic illness in the family history or other significant psychiatric disorder in addition to depression associated with underlying condition
- •n. Epilepsy or recurrent seizures
- •o. Use of strong CYP3A4 inducers, e.g. rifampicin, carbamazepine, phenytoin, phenobarbital and perforate St. Johns wort.
- •p. severe hepatic/ renal impairment
研究者
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