EUCTR2006-002216-10-CZ进行中（未招募）不适用
A Multicenter, Double-blind, Randomized, Parallel, Placebo-controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of 2 Oral Doses, 25 mg Twice Daily and 100 mg Twice Daily, of PG 760564 in Adult Patients with Rheumatoid Arthritis Receiving Methotrexate - RACER
Procter & Gamble Pharmaceuticals0 个研究点目标入组 270 人开始时间: 2006年10月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 270
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
- •Patients who meet all of the following criteria are eligible for participation in the study:
- •a. Men and women, 18 to 75 years of age, inclusive, at screening;
- •b. Who meet ACR criteria for RA, with a documented diagnosis of RA for at least 6 months;
- •c. Whose functional capacity is class I, II, or III according to the revised criteria of the ACR (Appendix 6);
- •d. Who have active disease despite treatment with MTX before washout of any DMARDs other than MTX. Active disease for this study will be defined as follows:
- •- At least 6 swollen joints and 6 tender joints; AND,
- •- At least one of the following 3 criteria must be present:
- •ESR of at least 28 mm/hour
- •Elevated CRP
- •Morning stiffness lasting at least 45 minutes;
- •d. Who have been treated with MTX for at least 24 weeks. The dose of MTX must be stable for at least 8 weeks, at 15-20 mg/week, or at 10 mg/week if that is the maximal tolerated dose, before starting study medication;
- •e. If female, must be (as documented in the patient notes):
- •- Post menopausal (at least 1 year without spontaneous menses), or
- •- Surgically sterile (if by tubal ligation, must have been performed at least 3 months before entry into the study), or
- •- Using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception, intra-uterine device) for at least 3 months prior to randomization and for the duration of the study including the follow-up period, in conjunction with a barrier method (e.g., condom and spermicide, diaphragm and spermicide) for the duration of the study and during the follow-up period;
- •NOTE: All contraception precautions for MTX must be followed.
- •f. If sexually-active male, must be surgically sterile (e.g., non-reversed vasectomy with confirmed azoospermia) or use condom during the study and during the follow-up period;
- •NOTE: All contraception precautions for MTX must be followed.
- •g. Who are willing and able to participate in the study and provide signed 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
- •- Active or latent tuberculous infection as defined as: history of tuberculosis (TB) OR Chest X ray suggestive of former or current tuberculous infection OR Positive tuberculin skin test with purified protein derivative of tuberculin (PPD) equal to or more than 5 mm in a patient without history of vaccination with bacillus Calmette-Guérin (BCG) OR In Europe, vaccination with BCG and positive PPD equal to or more than 8 mm OR In Europe, vaccination with BCG and positive PPD equal to or more than 5 mm but =8 mm and any of the following risk factors: silicosis, residents and employees of high-risk congregate settings, weight loss more than10% of ideal body weight, gastrectomy, jejunoileal bypass
- •- Active listeriosis
- •- History of episode of infection requiring hospitalization within 30 days before screening or episode of infection requiring IV antibiotics within 30 days before sceening or current active infection
- •- History of chronic or recurrent infections, or immunodeficiency
- •- Indwelling catheters
- •- Bronchiectasis
- •- History of uveitis or other inflammatory eye disease
- •- Autoimmune diseases other than RA [MCTD, seronegative spondyloarthropathy, SLE, UCTD, psoriatic arthritis, sarcoidosis, etc.], except Sjogren’s syndrome secondary to RA
- •- Chronic liver diseases, serologic evidence for infection with hep B or hep C
- •- History of alcohol or drug abuse
- •- Abnormal hepatic and renal functions; patients with known elevations of transaminases greater than 1.2 times ULN on 2 or more occasions in the 6 months before screening
- •- Platelets <100 x 109/L
- •- Abnormal WBC and/or significant abnormalities in other complete blood count (CBC) values. Hemoglobin (Hgb) <10 mg/dL
- •- Joint surgery within 2 months of screening
- •- History of lymphoma, leukemia, or lymphoproliferative disorders
- •- History of other malignancies other than treated basal cell carcinoma of the skin
- •- History of demyelinating diseases
- •- History of heart failure, NYHA class III or IV
- •- Pregnant or lactating women, or women who plan to become pregnant
- •- Personal or family history of prolonged QT syndromes.
- •- Other risk factors for torsade de pointes (TdP)
- •- Hypokalemia, hypomagnesemia, or hypocalcemia;
- •- Drugs known to cause prolongation of QT interval (must be off for at least 5 half-lives to be enrolled)
- •- Demonstrated likelihood not to comply with protocol requirements
- •- Current participation in another clinical trial involving active intervention
- •- Known allergy to components of the study medication
- •- History of efficacy failure with etanercept, infliximab, adalimumab, anakinra, and abatacept
- •- History of treatment with B cell depleting therapies and immunoadsorption
- •- History of treatment with p-38 MAP kinase inhibitors
- •- History of treatment with cyclophosphamide, or other alkylating agents; cyclosporine is allowed if >28 days prior to randomisation.
- •- Other diseases requiring immunosuppressive therapy
- •- Treatment with leflunomide within 6 months prior to study entry
- •- Intra-articular or intramuscular steroids within 4 weeks before screening
- •- Change in NSAID and/or corticosteroid doses within 30 days prior to entry into the study (Day 1 of the washout period)
- •- Treatment with any experimental/investigational therapy within the last 2 months for chemical and 6 months (from screening date) for biologic drugs
- •- Use of the following inducers of CYP 3A4 (carbamazepine, phenobarbital, phenytoin, St John's Wort and troglitazone) or inhibitors of CYP 3A4 (diltiazem, fluvoxamine, grape
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