EUCTR2007-006150-25-HU进行中（未招募）不适用
A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study to Evaluate the Safety and Efficacy of TRU-015 in Subjects With Active Seropositive Rheumatoid Arthritis on a Stable Background of Methotrexate - TRU-015
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc.0 个研究点目标入组 216 人开始时间: 2009年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
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 at time of signing the ICF
- •2. Meets the American Rheumatism Association 1987 revised criteria for classification of RA.
- •3. ACR functional class I-III.
- •4. At screening, active RA consisting of = 5 swollen and = 5 tender joints (28-joint count: see Attachment 3) and one or both of the following CRP or ESR criteria:
- •a. Erythrocyte sedimentation rate (ESR)(Westergren) = 28 mm/hr
- •b. CRP = 15 mg /L
- •5. Must be seropositive: Defined as a documented history of one or both of the following RF or anti-CCP criteria.
- •If a documented history of one or both of the following RF or anti-CCP criteria is not available, RF and anti-CCP will be tested with screening labs:
- •a. Positive RF
- •b.Positive anti-CCP
- •6. Currently receiving MTX regimen of 7.5 to 25mg of MTX weekly for at least 12 weeks prior to study day 1.
- •The dose and route of administration of MTX must be stable for at least 4 weeks prior to study day 1.
- •7. Women of childbearing potential must have a negative urine pregnancy test at screening and baseline. Women of childbearing potential are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Women of non-childbearing potential are defined as either postmenopausal (history of amenorrhea for = 52 weeks) or who are surgically sterile, such as after hysterectomy, bilateral oophorectomy, or tubal ligation (procedure
- •performed = 1 year before screening). This information must be documented in the subject’s source documents.
- •8. Women of childbearing potential must agree and commit to the use of hormonal contraception, double-barrier contraception, or an intrauterine device throughout the entire study (defined as the signing of the ICF to the
- •completion of the Conclusion of Subject Participation). Double-barrier contraception is defined as the use of a diaphragm, condom, or cervical cap plus a spermicidal vaginal foam, cream, jelly, suppository, or sponge.
- •WOCBP who have a vasectomized partner are also eligible for participation. Vasectomized partners must have had their vasectomy more than 6 months before study day 1.
- •9. Men must agree and commit to use a medically acceptable form of contraception for the entire study (defined as the signing of the ICF to the completion of the Conclusion of Subject Participation) unless surgically sterile.
- •Medically acceptable forms of contraception include properly used barrier forms of contraception.
- •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 216
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant women, nursing mothers or women planning to become pregnant during the study. 2. Any cardiovascular, neurological, metabolic, immunological, infectious, hepatic, or renal condition that, in the opinion of the investigator, could be detrimental to subjects participating in this study, including any clinically important deviations from normal clinical laboratory values or important concurrent medical events. 3. Any active, severe infections
- •4. Severe heart failure (NYHA Class IV) or severe, uncontrolled cardiac disease 5. Subjects with active tuberculosis as per country specific guidelines or history of tuberculosis. The following applies to subjects in Germany only: History of tuberculosis or positive PPD skin test at screening. The following are PPD skin test guidelines: (a)The PPD skin test should be read between 48 & 72 hours after application (b)Only indurations should be taken into account when interpreting results. (c)No induration is considered a negative result. (d)Any result with an induration of >5 mm in diameter is considered positive. (e)If induration is =5 mm in diameter, a 2nd PPD skin test is to be performed on contralateral arm on the day of reading of first PPD skin test. If the induration of the 2nd PPD skin test is >5 mm in diameter, this is considered a positive result. (f)Prior BCG should not be taken into account when interpreting a PPD result. 6. Subjects with other objectively confirmed or suspected rheumatic diseases including but not limited to, Lyme disease, psoriatic arthritis, spondyloarthropathy, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious arthritis, reactive arthritis or overlap syndrome. 7. Cancer, or a history of cancer (other than adequately resected cutaneous basal cell & squamous cell carcinomas or in situ cervical cancer). 8. History of alcohol or drug abuse that, in the opinion of the investigator, would interfere with the ability to comply with the study protocol. 9. Documented immunodeficiency disease including subjects with known human immuno deficiency virus (HIV) at time of screening. The following applies to subjects in Germany only: Known history of HIV, or positive HIV screening test, at the time of screening. 10 Subjects positive forhepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb), or hepatitis C antibody (HepCAb) with confirmation by RIBA, or history of drug-induced liver injury, or documented liver cirrhosis or documented fibrosis at any time before the Baseline visit. 11. Any clinically significant laboratory abnormality, including: Hemoglobin <8.5 g/dL (SI units: <85 g/L); White blood cell (WBC) count <3.50 x 103/mm3 (SI units: <3.50 x 10 to the power of 9/L); Platelets <125,000/mm3 or = 1,000,000/mm3 (SI units: <125 x 10 to the power of 9/L or =1,000 x 10 to the power of 9/L); Aspartate minotransaminase (AST) or alanine aminotransaminase (ALT) >1.5 x upper limit of normal (ULN); Serum creatinine >2 mg/dL (SI units: >177 mol/L)
- •12. Clinically significant finding on chest radiograph.Chest x-ray must be performed during screening period unless radiograph was performed within the 24 weeks prior to Baseline. 13. For subjects who consent to the MRI sub-study:(a) Any permanent reactive metal implants contained in or on the body.(b) Contra indications to Gadolinium contrast agents including, but not limited to, glomerular filtration rate (GFR) <30 ml/min. 14. Lack of peripheral venous access. 15. Any prior use of rituxima
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