PER-100-08已完成未知
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Patients With Rheumatoid Arthritis Who Have Failed at Least One Biologic
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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 70（—）
- 性别
- All
入选标准
- •Patients must provide written informed consent by signing an Informed Consent Form (FCI) approved by a CRI / CE before being admitted to this study.
- •Men and women, 18 years of age or older, with active RA for at least 12 months prior to administration on Day 1 (functional class I-III, eg, not limited to bed or chair of wheels) Active AR is defined as the presence of (a)> 6 inflamed joints (28 joint count); AND (b)> 6 sensitive joints (28 joint count) AND at least one of the following (c) YSG> 28 mm / h or POR> LNS for the reference core laboratory.
- •Patients are currently receiving or previously received a biological treatment with a TNF inhibitor, rituximab, abatacept or anakinra at an approved dose for> 3 months prior to administration on Day 1 and were designated as failure to biological treatment due to lack of efficacy, safety or tolerability.
- •Patients can receive stable doses of methotrexate (MTX), azathioprine (not in combination with MTX), leflunomide (not in combination with MTX), sulfasalazine, chloroquine, hydroxychloroquine, gold, NSAIDs (including C0X2 inhibitors), minocycline or doxycycline The dose must have been stable for at least 30 days prior to administration on Day 1 and should not be modified during the wash, selection and treatment periods, unless indicated by the tolerability requirements. Patients taking MTX should have received weekly doses of MTX (7.5-25 mg / week) for a minimum of 3 months prior to administration on Day 1 and should be receiving a stable dose of MTX, without changes in the route, during the 6 weeks prior to administration on Day 1. Patients receiving MTX should also be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to administration on Day 1.
- •Women of childbearing age should be fully informed about the potential of R788 to adversely affect the fetus and, if they are sexually active, they should agree to use a well-established method of contraception during the study (oral contraceptives, mechanical barrier, long-acting hormonal agent) ). These patients should not be lactating and should have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
- •The patient must be otherwise in good health condition, which will be determined by the Investigator based on a clinical history, physical examination and selection laboratory tests during the selection period. See the exclusion criteria for specific exclusions.
- •In the opinion of the Researcher, the patient has the capacity to understand the nature of! study and any danger that represents their participation, and to communicate satisfactorily with the Researcher and to participate in, and comply with, the requirements of the complete protocol.
排除标准
- •1) The patient has a history of, or currently suffers from, a significant disease, medium condition (in addition to arthritis) or laboratory abnormality that, in the opinion of the Investigator, could affect the conduct of the study. Specifically, patients who suffer the following are excluded;
- •a) poorly controlled or uncontrolled hypertension;
- •b) another autoinumne disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritic syndromes (gout, Lyme disease, Reiter´s syndrome);
- •c) surgery or recent serious infectious disease (in the 2 months prior to administration on Day 1);
- •d) recent history (the 5 years prior to administration on Day 1) of, or treatment for, a malignancy except nonmelanomatous skin cancer, or any history of.lilyfoma;
- •e) positive Hepatitis B surface antigen;
- •f) antibody to positive Hepatitis C; it can be included if the recombinant immunoblot analysis (RIBA) of Hepatitis C is negative, or if the HCV RNA is negative (qualitative);
- •g) interstitial pneumonitis or active lung infection on chest x-ray (taken one month prior to selection);
- •h) Tuberculosis (TB): the skin test for TB should be negative (if the patient never received vaccination, or if he was vaccinated more than 10 years ago, in this context, negative means induration <5 mm); if the TB skin test is positive (in an unvaccinated patient), an adequate prophylactic anti-TB regimen should be documented: Patients must have completed anti-TB treatment 1 year before administration on Day 1. For vaccinated patients If the vaccine was applied less than 10 years ago and the skin test is positive, an exception may be requested if the induration is <10 mm, the chest X-ray shows no signs of TB, confirmed by a radiologist, or the patient took an isoniazid course (or a comparable regimen), known laboratory abnormalities: ALT> 1.2x LNS, creatinine> 1.5x LNS, ANC <2,500 / mm ^ or lymphocyte count <600 / mm3, Hb <9 g are excluded / dL, platelet count <125,000 / mm3.
- •2) The patient has a history of substance abuse, drug addiction or alcoholism. Patients can consume up to 4 units of alcohol per week; however, alcohol consumption should be avoided during the 72 hours prior to laboratory evaluations. Patients who can not reliably comply with this requirement should be excluded. One unit of alcohol is defined as: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet table wine = 3 oz or 89 mL; distilled beverages with 80 alcohol = 1.5 oz or 44 mL.
- •3) The patient has been previously treated with R788 in a different protocol.
- •4) The patient has a pacemaker, aneurysm clips or other contraindication for an MRI.
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