EUCTR2005-003495-38-GR进行中（未招募）1 期
Part A: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 5 dose regimens of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy.Part B: A randomized, double-blind, placebo-controlled study to determine the efficacy and safety of 1 dose of RO4402257 in patients with active rheumatoid arthritis (RA) on stable methotrexate (MTX) therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
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
- •Able and willing to give written informed consent and to comply with the study protocol
- •Active RA as diagnosed by the 1987 American College of Rheumatology (ACR; formerly American Rheumatism Association) criteria (Appendix 2)
- •Age greater than or equal to 18 years
- •Receiving treatment for RA on an outpatient basis
- •Has received MTX for at least 24 weeks, of which the last 8 weeks prior to baseline was at a single dose level between 10 mg and 25 mg weekly; the route of administration also remained unchanged for the 8 weeks prior to baseline
- •If taking either hydroxychloroquine (HCQ) or chloroquine (CQ), dose must be stable for 8 weeks prior to baseline
- •Swollen joint count (SJC) greater than or equal to 6 (66 joint count) and tender joint count (TJC) greater than or equal to 8 (68 joint count) at screening and baseline
- •At screening, either high sensitivity C-reactive protein (hs-CRP) greater than or equal to 0.6 mg/dL (6 mg/L) or erythrocyte sedimentation rate (ESR) = 28 mm/h or morning stiffness greater than 45 minutes
- •Females of child-bearing potential and nonsterilized males with female partners of child-bearing potential only if willing to use a reliable means of contraception (e.g., physical barrier, contraceptive pill, patch, or IUD) during the study and for 4 weeks following the last dose of study drug
- •If female and of childbearing potential, must have a negative pregnancy test within 3 weeks prior to randomization and at baseline
- •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
- •Major surgery (including joint surgery) within 8 weeks prior to screening or any planned surgery within 3 months after randomization
- •Rheumatic autoimmune disease other than RA (including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis), or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, Felty’s syndrome); Sjögren’s Syndrome with RA is allowed
- •Bed-ridden or confined to a wheelchair
- •Prior history of, or current inflammatory joint disease other than RA (e.g., tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including asthma), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
- •History of malignancy, including solid tumors and hematologic malignancies (except basal cell carcinoma of the skin that has been excised and cured)
- •One of the following:
- •History of active tuberculosis
- •Chest radiographic findings consistent with active or latent tuberculosis
- •Positive PPD (greater than or equal to 10 mm induration) unless there is a history of BCG immunization and the investigator ascertains that there is no recent history of tuberculosis exposure
- •Known active bacterial (including mycobacterial), viral (including HIV), fungal, or other infections (excluding fungal infections of nail beds)
- •Any episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
- •History of recurrent bacterial infections as an adult
- •History of hereditary or acquired immune deficiency disorder
- •Immunization with a live vaccine within 4 weeks prior to baseline
- •Pregnant women or nursing (breastfeeding) mothers
- •History of alcohol, drug or chemical abuse within the six months prior to screening
- •Neuropathies or other conditions that might interfere with pain evaluation
- •Current DMARD therapy other than MTX , HCQ or CQ
- •Previous treatment with a biologic agent
- •Treatment with another investigational agent within 6 weeks of screening, or 5 half-lives of the 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, and anti-CD20)
- •Previous treatment with alkylating agents
- •Greater than 10 mg/day of prednisone (or equivalent; please refer to Appendix 1) < 4 weeks prior to the baseline visit
- •Intraarticular or parenteral corticosteroids < 4 weeks prior to the baseline visit
- •Sulfasalazine, azathioprine, cyclosporine, thalidomide, D-penicillamine, or tacrolimus within 8 weeks prior to baseline, and leflunomide within 12 weeks (or 4 weeks after 11 days of standard cholestyramine washout) prior to baseline
- •Gold compounds if less than 8 weeks prior to baseline; immunoadsorption columns if less than 6 months prior to baseline
- •Screening CPK > 2 x ULN
- •Screening alanine aminotransferase (ALT/SGPT) or aspartate aminotransferase (AST/SGOT) > 1.5 x ULN
- •Screening calculated creatinine clearance (Cockroft-Gault) < 50 mL/minute (refer to Appendix 3 for Cockroft-Gault formula)
- •Screening platelet count < 100,000 cells/mm3
- •Screening hemoglobin < 9 g/dL
- •Screening white blood cells < 3000 cells/mm3
- •Positive Hepatitis B surface antigen or Hepatitis C antibody
- •History of positive HIV antibody or
研究者
相似试验
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapsesMultiple sclerosisMedDRA version: 12.0Level: PTClassification code 10028245Term: <Manually entered code. Term in E.1.1>EUCTR2004-000555-42-DKSanofi-aventis US, Inc1,080
进行中（未招募）
1 期
To evaluate the efficacy and safety of CNP520 in participants at risk for the onset of clinical symptoms of Alzheimer's Disease (AD)MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852Alzheimer's diseaseEUCTR2016-002976-28-ITOVARTIS PHARMA AG1,144
进行中（未招募）
1 期
Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173Primary Sjögren's syndromeMedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersEUCTR2014-004616-12-DEovartis Pharma Services AG30
进行中（未招募）
1 期
Efficacy and safety of finerenone in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney diseaseType II Diabetes Mellitus and Diabetic Kidney DiseaseMedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2015-000950-39-ITBAYER AG12,800
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group, fixed-dose, 8-weektreatment, multi-center trial evaluating the dose effect relationship for efficacy and the safety of 3 oral doses of surinabant: 2.5, 5 and 10mg/day as an aid to smoking cessation in cigarette smokers - SURSMOKEAid to smoking cessation in cigarette smokersMedDRA version: 8.1Level: LLTClassification code 10057852Term: Nicotine dependenceEUCTR2006-005334-21-DEsanofi-aventis recherche et developpement805