EUCTR2004-004022-27-ES进行中（未招募）不适用
Phase IIa, multicenter, randomised, double-blind, placebo controlled study of the efficacy and safety of RO0506997, an a4 integrin antagonist, in combination with methotrexate, versus methotrexate alone, in patients with mild/moderate active rheumatoid arthritis (RA) who have had a partial response to a stable dose of methotrexate.
F.Hoffmann - La Roche Ltd0 个研究点目标入组 160 人开始时间: 2005年11月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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.Patients with RA diagnosed according to the revised 1987 American Rheumatism Association (ACR) criteria.
- •2.Having RA for a minimum of 6 months.
- •3.Receiving treatment on an outpatient basis.
- •4.Have failed no more than 5 DMARDs.
- •5.Have received oral methotrexate (not necessarily at constant dose) for at least 24 weeks, with a stable dose for at least 8 weeks prior to their baseline visit. The dose of methotrexate at the baseline visit must be at least 10 mg/week and no greater than 25 mg/week.
- •6.Swollen joint count (SJC) = 6 (66 joint count) at baseline.
- •7.Tender joint count (TJC) = 8 (68 joint count) at baseline.
- •8.At least 1 of the following 3 parameters at screening:
- •- CRP = 1.5 mg/dL as determined by sensitive CRP assay
- •- ESR = 28 mm/h
- •- Morning stiffness > 45 minutes
- •9.Age = 18 years.
- •10.Corticosteroids (= 10 mg/d prednisolone or equivalent) or NSAIDs are permitted if stable for at least 4 weeks prior to baseline. These must remain stable for the duration of the study.
- •11.Able and willing to receive a stable dose of greater than or equal to 5 mg/week folic acid or the equivalent, given as either a single dose or as divided daily doses.
- •12.Able and willing to give written informed consent and comply with the requirements of the study protocol.
- •13.Women who are not either surgically sterile (tubal ligation or removal or ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least 1 year) must commit to use a barrier form of contraception in addition to either an intrauterine device or hormonal contraception until at least 1 month after the end of treatment. (Abstinence or sterile partner acceptable).
- •14.Men who are not surgically sterile must commit to use a condom for contraception until 1 month after the end of treatment. (Abstinence or sterile partner acceptable).
- •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.Elevation of hepatic transaminases (AST or ALT) > 2x the upper limit of normal during previous treatment with methotrexate or leflunomide, or >1.5x the upper limit of normal at screening.
- •2.Baseline QTc > 450 msec.
- •3.Bone/joint surgery within 6 months prior to screening (including joint fusion).
- •4.Rheumatic autoimmune disease other than RA (Sjögren’s Syndrome with RA is allowable).
- •5.Felty’s syndrome.
- •6.ARA functional class IV disease.
- •7.Active or history of rheumatoid vasculitis.
- •8.Prior history of gout.
- •9.Prior history of systemic diseases associated with arthritis, such as inflammatory bowel disease or infectious diseases associated with arthritis, such as Lyme disease or reactive arthritis.
- •10.Chronic fatigue syndrome or fibromyalgia.
- •11.Concomitant diseases or conditions that could interfere with clinical evaluations. This includes, but is not limited to, cancer, alcoholism, drug dependency or abuse, psychiatric diseases and active infections.
- •12.Any condition that would interfere with absorption of oral medicine.
- •Excluded Previous/concomitant medications
- •1.Concurrent treatment with any DMARD (DMARDS, including sulphasalazine (SSA) and hydroxychloroquine, must be washed out for 28 days prior to baseline).
- •2.Previous therapy with anti-TNF or IL-1 antagonist, or other biologic therapy at any time, including previous treatment with any cell depleting therapies (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD20).
- •3.Treatment with any investigational agent within 4 weeks or 5 half lives of screening, whichever the longer, or 3 months if the experimental agent is a DMARD
- •4.Patients receiving leflunomide within 6 months of screening, unless an eleven day standard cholestyramine washout is completed 28 days before screening.
- •5.Previous treatment within 6 months with immunosuppressive agents, for example azathioprine, mycophenolate mofetil, FK506 or cyclosporin A.
- •6.Previous treatment with alkylating agents within 6 months of the screening visit, such as cyclophosphamide or chlorambucil.
- •7.Greater than 10 mg/day of prednisolone (or equivalent) within 4 weeks prior to screening visit.
- •8.Intraarticular or parenteral corticosteroids within 4 weeks prior to the screening visit
- •9.Immunization with a live or attenuated vaccine (e.g. certain formulations of influenza vaccine) is specifically prohibited during the study, as well as patients, who have had recent (within 4 weeks) immunization with live or attenuated virus.
- •Exclusions for General Safety
- •1.Evidence of serious uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
- •2.Subjects susceptible to, or with a history of biliary obstruction or with either an autoimmune or a clinically significant concomitant disease that predisposes to such.
- •3.Uncontrolled disease states, such as, but not limited to asthma, where flares are commonly treated with oral or parenteral corticosteroids.
- •4.Active infection, with the exception of fungal infections of nail beds.
- •5.History of recurrent significant infection or history of recurrent bacterial infections (e.g. Neisseria, Pneumococcal infections).
- •6.Lymphopenia, defined as total lymphocyte count < 1 x 103/µL for more than 3 months duration immediately (within 6 months) prior to screening.
- •7.Primary or secondary immunodeficiency (history of or currently active).
- •8.Prior history of cancer, including solid tumors and hematologic maligna
研究者
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