EUCTR2004-004995-35-AT进行中（未招募）不适用
A PHASE II MULTI-CENTER, RANDOMIZED, BLINDED STUDY OF 14 WEEKS DURATION COMPARING THE EFFECT OF CRx-139 PLUS DMARD THERAPY TO THAT OF STEROID PLUS DMARD THERAPY USING ACR-20 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS PARTIALLY RESPONSIVE TO THE DMARD. - CRx-139-RA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 220
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 be at least 18 years of age.
- •Subject must have active, moderate to severe rheumatoid arthritis.
- •Subject must have at least 6 swollen joints (max = 66) and 9 tender joints (max = 68).
- •Subject must have been on DMARD for at least 3 months and be on a stable dose of DMARDs for at least 1 month (2 months for methotrexate) prior to Baseline. Subjects on stable methotrexate may receive it by the parenteral or oral route, but the route must remain constant throughout the study.
- •Subject must have voluntarily signed the informed consent.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has any serious medical condition likely to interfere with the objectives of the study (namely evaluation of changes in ACR-20 brought about by CRx-139). This may include the need to take interfering medications or undergo alternative treatments. Patients with peptic ulcers, active tuberculosis, or acute psychosis are specifically excluded, as are patients taking Thioridazin and patients who have taken any MAO-inhibitor within 2 weeks before entering this study.
- •Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Subjects on a stable dose (minimum of 6 months) of hormonal birth control may participate in the study.
- •Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month (<=28 days) prior to Baseline. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to Baseline. An inhaled glucocorticoid is permitted.
- •Subject has been treated with anti-TNFAlpha biologics Remicade® or Humira®, or any other prescription biological drug, within 2 months prior to Baseline, or Enbrel® within 1 month prior to Baseline.
- •Subject is currently taking any anti-depressants or anti-seizure medications.
- •Subject has a history of depression, biopolar disorder or schizophrenia; or, in the investigator´s opinion, has any sign of clinical depression, bipolar disorder or schizophrenia.
- •Subject has a history of seizure disorders.
- •Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to Baseline.
- •Subject has any active infections or has had any surgical procedures within 30 days of Baseline.
- •Subject has severe osteoporosis as determined by the physician, or defined by a fracture within 6 months of Baseline.
- •Subject has poorly controlled diabetes mellitus as defined by an HbA1C value = 7.0%.
- •Subject is known to have HIV or Hepatitis.
- •Subject is currently participating in a clinical research study, or has undergone administration of any investigational drug within 30 days of Baseline.
- •Subject has a history of hypersensitivity to steroids and/or selective serotonin re-uptake inhibitors.
- •Subject is not ambulatory.
- •Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
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