PER-109-06已完成未知
A 12-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Investigate The Safety, Pharmacokinetics, And Efficacy Of PH-797804, Administered Orally Once Daily In Subjects With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Have provided written informed consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •2. Have an age> 18 years.
- •3. Having presented a failure to at least 1 DMARD regimen.
- •4. During the last 6 months prior to the Screening visit, have received a diagnosis of RA based on the Revised Criteria of the American Society of Rheumatology.
- •5. Under the current treatment regimen, currently maintain a minimum disease activity level characterized by: a) ≥ 6 tender or painful joints to movement. b) ≥ 6 joints inflamed. c) C-reactive protein (CRP) (1 mg / dL (10 mg / L).
- •6. Complies with the Revised Criteria ACR 1991 for Global Functional Status in AR, Class I, II, or III.
- •7. The patient has complied with the washing periods if he has been treated with any of the treatments that require one.
- •8. If the patient is female, she must have met either: a) If she is not potentially fertile, the patient is amenorrheic for at least 2 years, or has had a hysterectomy and / or bilateral oophorectomy at least 8 weeks before screening. OR b) If the potentially fertile patient, must agree to use acceptable contraceptive methods.
- •9. If the patient is male, he or she must agree to use acceptable contraceptive methods.
排除标准
- •1. A diagnosis of any other inflammatory arthritis or fibromyalgia.
- •2. A history of: a) Hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease severe, progressive, and uncontrolled within 6 months before the first dose. b) Associated significant cardiac disease. c) Chronic or serious or life-threatening infection within 6 months of the first dose. d) Untreated tuberculosis and / or positive tuberculin reaction to PPD without known vaccination with the Bacillus Calmette-Guerin (BCG) vaccine. e) Positive result to T-SPOT ™ .TB. f) Significant trauma or major surgery within 8 weeks of the first dose of study medication. f) Alcohol abuse with less than 6 months of sobriety; drug abuse within 3 years of the start of the study. g) Cancer, which has been in remission for <5 years.
- •3. Patients presenting with: a) Any condition that may affect the oral absorption of the drug. b) Any clinically significant skin lesion as described in the CTCAE Version 3.0. c) Body temperature of> 38 ° C (98.6 ° F). d) Infection with human immunodeficiency virus (HIV) or Hepatitis B or C. e) Any clinically significant active infection. f) Congestive heart failure Class III-IV. g) A confirmed average of the QTc interval in triplicate to the Selection> 450 ms. h) A clinically significant abnormal finding on the ECG.
- •4. Evidence of organic dysfunction or hematopoietic disorder.
- •5. Patients who require prohibited concomitant medications.
- •6. Pregnant or breast-feeding patients.
研究者
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