NL-OMON30408尚未招募2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
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
- 18 至 99（—）
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 70 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);12
- •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;
- •e. 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;
- •f. If female, must be (as documented in the patient notes):
- •Post menopausal (>= age 50 and 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.
- •g. 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
- •(PG-760564) follow-up period;
- •NOTE: All contraception precautions for MTX must be followed.
- •h. Who are willing and able to participate in the study and provide signed informed consent.
排除标准
- •Patients with any of the following will not be entered into the study:
- •a. Active or latent tuberculous infection as defined below:
- •1. History of tuberculosis (TB), or
- •2. Chest X-ray suggestive of former or current tuberculous infection, or
- •3. Positive tuberculin skin test with purified protein derivative of tuberculin (PPD) >=5 mm in a patient without history of vaccination with bacillus Calmette-Guérin (BCG), or
- •4. In Europe, vaccination with BCG and positive PPD >8 mm, or
- •5. In Europe, vaccination with BCG and positive PPD >=5 mm but <=8 mm and any of the following risk factors:
- •i. silicosis
- •ii. residents and employees of high-risk congregate settings
- •iii. weight loss >10% of ideal body weight
- •iv. gastrectomy
- •v. jejunoileal bypass, or
- •6. In US, vaccination with BCG and positive PPD >=5 mm;
- •b. Active listeriosis;
- •c. History of episode of infection requiring hospitalization within 30 days before screening or episode of infection requiring intravenous (IV) antibiotics within 30 days before screening or current active infection;
- •d. History of chronic or recurrent infections, or immunodeficiency;
- •e. Indwelling catheters;
- •f. Bronchiectasis;
- •g. History of uveitis or other inflammatory eye disease;
- •h. Autoimmune diseases other than RA [mixed connective tissue disease (MCTD), seronegative spondyloarthropathy, systemic lupus erythematosus (SLE), undifferentiated connective tissue disease (UCTD), psoriatic arthritis, sarcoidosis, etc.], except Sjogren*s syndrome secondary to RA;
- •i. Chronic liver diseases, serologic evidence for infection with hepatitis B or hepatitis C [positive hepatitis B surface antigen (HepBsAg) or hepatitis C antibody (HepCAb)];
- •j. History of alcohol or drug abuse;
- •k. Abnormal hepatic and renal functions (LFTs and serum creatinine values elevated above the Central laboratory normal reference range on screening or baseline visits); patients with known elevations of transaminases greater than 1.2 times the upper limit of normal (ULN) on 2 or more occasions in the 6 months before screening will be excluded.
- •l. Platelets <100 x 109/L;
- •m. Abnormal WBC and/or significant abnormalities in other complete blood count (CBC) values. Hemoglobin (Hgb) <10 mg/dL;
- •n. Joint surgery within 2 months of screening;
- •o. History of lymphoma, leukemia, or lymphoproliferative disorders;
- •(PG-760564)
- •p. History of other malignancies other than treated basal cell carcinoma of the skin;
- •q. History of demyelinating diseases;
- •r. History of heart failure, New York Heart Association (NYHA) class III or IV (Appendix 7);
- •s. Pregnant or lactating women, or women who plan to become pregnant;
- •t. Personal or family history of prolonged QT syndromes. Family history of sudden cardiac death due to arrhythmia or unknown cardiac problems (presumed QT problems);
- •u. Other risk factors for torsade de pointes (TdP), e.g., history of significant arrhythmias including history of ventricular tachycardia or fibrillation [unless patient has implantable cardiac defibrillator (ICD)]; atrial fibrillation or flutter; history of sick sinus syndrome or significant heart blocks (unless patient has pacemaker); ECGs showing prolongation of QTc interval (>440 msec);
- •v. Hypokalemia, hypomagnesemia, or hypocalcemia;
- •w. Drugs known to cause prolongation of QT interval (must be off for at least 5 half-lives to be enrolled) (see list in Appendix 8);
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