A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of rhuMAb 2H7 (Ro 496-4913, PRO70769) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A

F Hoffmann-La Roche Limited0 个研究点目标入组 160 人开始时间: 2005年12月7日最近更新: 2022年8月8日

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: 160

研究概览入排标准研究者记录与标识符相似试验

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 must meet the following criteria to be eligible for study entry:
•Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
•Aged 18–80 years
•Have active disease defined as:
•Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA (see Study Procedures and Administrative Manual)
•Positive serum rheumatoid factor (=20 IU/L)
•Current treatment for RA on an outpatient basis
•At screening: C-reactive protein (CRP) =1.5 mg/dL (15 mg/L)
•erythrocyte sedimentation rate (ESR) =28 mm/hr
•Swollen joint count of =8 (66 joint count) and tender joint count of =8 (68 joint count) at screening and randomization (see Study Procedures and Administrative Manual)
•Previous and current treatments:
•Have failed treatment (because of lack of tolerability or efficacy) with at least one but no more than five DMARDs or biologics (other than MTX)
•Current treatment with MTX at a dose of 10–25 mg weekly (p.o. or parenterally) for at least 12 weeks, with the last 4 weeks prior to screening at a stable dose
•All DMARDs other than MTX should be withdrawn at least 4 weeks prior to randomization (8 weeks for etanercept, infliximab, adalimumab and leflunomide [after cholestyramine drug removal for leflunomide unless it was discontinued 12 weeks prior to treatment])
•If receiving current treatment with corticosteroids, the dose must not exceed 10 mg/day prednisone or equivalent and the last 4 weeks prior to screening must be at a stable dose
•If receiving current treatment with NSAIDs, the patient must be on stable dose for the last 2 weeks prior to screening
•Patient must be willing to receive oral folic acid
•For patients of reproductive potential (males and females), a reliable means of contraception must be used (e.g., hormonal contraceptive, intrauterine device, physical barrier)
•For females of childbearing potential (including those who have had a tubal ligation), a serum pregnancy test within 2 weeks prior to randomization must be negative.
•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

•Patients who meet any of the following exclusion criteria related to rheumatoid arthritis are ineligible for study entry:
•Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
•Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty’s syndrome); patients with Sjogren’s syndrome with RA are eligible.
•Functional Class IV as defined by the ACR classification of functional status in RA (see Study Procedures and Administrative Manual)
•History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome).
•Exclusion Criteria Related to Medications
•Patients who meet the following criteria related to medications will be excluded:
•Concurrent treatment with any DMARD (except MTX) or any anti–TNF-a therapy or other biologic therapy
•Treatment with any investigational agent within 4 weeks of screening or five half-lives of the investigational drug (whichever is longer)
•Previous treatment with any cell-depleting therapies, including investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, or alefacept)
•Previous treatment within 6 months with IV ?-globulin or Prosorba® column
•Intra-articular or parenteral corticosteroids within 4 weeks prior to the screening visit
•Receipt of a live/attenuated vaccine within 4 weeks prior to randomization
•Previous treatment with rituximab (MabThera®/Rituxan®)
•Exclusion Criteria Related to General Safety
•The following are exclusions related to general safety:
•History of severe allergic or anaphylactic reactions to humanized or chimeric monoclonal antibodies
•Known active bacterial, viral, fungal, mycobacterial, or other infection (including atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
•History of active tuberculosis (TB) or concurrent treatment for TB
•Positive purified protein derivative (PPD) screening test (see Study Procedures and Administrative Manual for Centers for Disease Control guidelines and definition of high risk individuals)
•History of recurrent significant infections
•Primary or secondary immunodeficiency (history of or currently active)
•Evidence of significant and/or uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, or gastrointestinal disorders
•History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been excised and resolved)
•History of alcohol, drug, or chemical abuse within the 6 months prior to screening
•Neuropathies and neurovasculopathies that might interfere with pain evaluation
•Lack of peripheral venous access
•Pregnancy or lactation
•Exclusion Criteria Related to Laboratory Findings at Screening
•Patients who meet the following criteria related to laboratory findings at screening will be

研究者

发起方

F Hoffmann-La Roche Limited

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