EUCTR2005-001319-23-ES进行中（未招募）1 期
A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 3 Oral Doses of ERB-041 in Subjects With Rheumatoid Arthritis on a Background of Methotrexate Therapy.Estudio aleatorizado, de grupos paralelos, en doble ciego y controlado con placebo, dirigido a evaluar la eficacia y la seguridad de 3 dosis orales distintas de ERB-041 en sujetos con artritis reumatoide en tratamiento de fondo con metotrexato
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical resaearch and Development0 个研究点目标入组 260 人开始时间: 2005年6月22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
- 260
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. The American College of Rheumatology (ACR) criteria for RA (see Attachment 1). Note: Radiographs of the hand and feet may be performed at screening only if required to establish the diagnosis of RA.
- •2. ACR functional class I-III (see Attachment 2).
- •3. Disease duration of at least 6 months.
- •4. Disease onset at > 16 years of age.
- •5. Aged 18 to 80 years.
- •6. Must be treated with a stable, well-tolerated dose of MTX (7.5 to 20 mg, oral [PO], intramuscular [IM] or subcutaneous [SC]) weekly for at least 12 weeks prior to the baseline visit, and be willing to remain on this fixed dose for the duration of the study.
- •7. Have active RA consisting of = 5 swollen and = 5 painful joints (28-joint count) and meet at least 1 of the following 3 criteria: ·Erythrocyte sedimentation rate (ESR) (Westergren) = 28 mm/hr.·C-reactive protein (CRP) = 15 mg/L. ·Morning stiffness = 45 minutes.
- •8. Women of childbearing potential, who must have a negative pregnancy test, and all male subjects, must agree and commit to use a medically acceptable nonhormonal method of birth control during the study and for at least 12 weeks after the last dose of test article.
- •a) Women of childbearing potential are women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- •b) Women of nonchildbearing potential are:
- •i) Postmenopausal women with a history of amenorrhea for ³ 12 months and with serum FSH > 40 IU/L.
- •ii) Women who are surgically sterile, such as after a hysterectomy, bilateral oophorectomy, or tubal ligation (procedure performed at least 1 year before screening). This information must be documented in subject’s study file.
- •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
- •1. Any prior use of total lymphoid irradiation, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein.
- •2. Inability to satisfy baseline exclusion criteria concerning prior use of RA therapies for times stipulated (See Baseline Exclusion Criteria, Section 12.2.2 points 1 through 9) at anticipated time of the baseline visit.
- •3. Clinically significant findings from a chest radiograph (posteroanterior [PA] and lateral views).Note: A report from a chest X-ray radiographs performed in the previous 12 months is acceptable for the screening evaluation.
- •4. Men with abnormal PSA levels, testicular mass or symptomatic benign prostatic hypertrophy
- •5. Women with clinically significant findings on the following:
- •a. Mammogram with suspicious abnormality or abnormality suggestive of malignancy if age ³ 40 years.
- •b. Findings suggestive of neoplasia during the gynecologic examination.
- •c. Papanicolau (Pap) test result with high-grade intraepithelial lesions or malignancy. Note: Reports from mammogram, gynecologic examination and Pap test performed in the previous 9 months must be available in the subject’s study file and the results must satisfy the screening criteria above.
- •d. Women with abnormal vaginal bleeding within 6 months before screening.
- •6. Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article.
- •7. History of poor compliance or history of drug abuse/alcohol abuse, or excessive alcoholic beverage consumption (ie, 3 or more alcohol-containing drinks per day) that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
- •8. Any cardiovascular, neurologic, metabolic, immunologic, infectious, hepatic, or renal condition that the physician judges could be detrimental to subjects participating in this study, including any clinically important deviations from normal clinical laboratory values or important concurrent medical events. Significant medical conditions include:
- •a) Cancer, or a history of cancer:
- •i. Women with a history of breast, cervical, ovarian, vaginal, or uterine cancer at any time will be excluded.
- •ii. Men with a history of breast, prostate, or testicular cancer at any time will be excluded.iii.Other cancers, or their history (other than successfully resected cutaneous basal and squamous cell carcinoma) within 5 years before screening.
- •b) Cardiovascular disease:
- •i. History or presence of congestive heart failure (CHF) (New York Heart Association classification for CHF: Class III or IV).
- •ii. History of myocardial infarction within 1 year before screening.
- •iii. Unstable angina pectoris within 6 months before screening visit.
- •iv. Cardiac arrhythmia or clinically significant electrocardiogram (ECG) abnormality, such as ischemia.
- •v. Clinically significant peripheral artery disease.vi.History of stroke or transient ischemic attack within 1 year before screening.vii.History of deep vein thrombosis or pulmonary embolism.
- •c) Poorly controlled diabetes.
- •d) History of clinically significant pulmonary disease.
- •e) Liver cirrhosis or fibrosis.
- •f) History of human immunodeficiency virus (HIV) infection.
- •g) Immunodeficiency syndromes including Felty’s syndrome, large granular lymphocyte syndrome, or connective tissue diseases other than RA (eg, psoriatic arthritis, systemic lupus erythematosus, prim
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