EUCTR2005-003558-83-IT进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis. - AMG 108
AMGEN S.P.A.0 个研究点目标入组 784 人开始时间: 2006年6月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 784
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
- •Subjects must be diagnosed with RA as determined by meeting 1987 American College of Rheumatology ACR classification criteria Appendix H Active RA defined as 8805;6 swollen joints and 8805;6 tender/painful joints and at least one of the following Erythrocyte sedimentation rate ESR 8805;28 mm/hr, C-reactive protein CRP 2.0 mg/dL, or duration of morning stiffness 8805;45 minutes at time of screening Duration of RA for at least 6 months Men or women 8805;18 and 8804;70 years old Subjects with active disease after a minimum of 4 weeks of MTX or 2 weeks of sulfasalazine or hydroxychloroquine treatment. Stable use of oral or SC MTX at 10-25 mg weekly 8805;4 weeks prior to screening If using non-steroidal anti-inflammatory drugs NSAIDs or oral corticosteroids, subjects must be on stable use of NSAIDs or oral corticosteroids 8804;10 mg prednisone or equivalent 8805;4 weeks prior to screening Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •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
- •Previous receipt of commercial or experimental biologic therapies including AMG 108, anakinra AMG 719, soluble IL-1 type II Page 6 of 123 receptor, etanercept, infliximab, adalimumab, onercept, pegsunercept, abatacept, or rituximab or any other biologic therapy used to treat an inflammatory disease Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, cardiovascular disease or hypertension Malignancy within 5 years except treated in-situ cervical cancer or squamous or basal cell carcinoma Presence of a serious infection, defined as requiring hospitalization or recurrent, acute or chronic infections within 8 weeks before screening Prior or current history of Mycobacterium tuberculosis infection or exposure Class IV RA Hochberg 1992 according to ACR revised response criteria Appendix I or radiographic end stage disease Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening Felty s syndrome Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sj gren s syndrome Known to be positive for hepatitis B surface antigen HbsAg , hepatitis C virus HCV or HIV White blood cell count 3.0 x10 3 / L, absolute neutrophil count ANC of 2.5 x 10 3 / L, or platelet count of 125 x 10 3 / L at screening Elevated aspartate aminotransferase AST or alanine aminotransferase ALT 1.5 x upper limit of normal ULN at screening Elevated serum creatinine 1.5 x upper limit of normal or 2 mg/dL at screening Laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results Intra-articular IA or systemic corticosteroid injections within 4 weeks of screening Any DMARD other than MTX within 6 weeks of screening Cyclophosphamide within 6 months of screening Received live vaccines within 3 months of first dose of investigational product Any investigational therapy within 4 weeks of screening Pregnant or nursing Sexually active subjects and their partners who are of childbearing potential ie, neither surgically sterile nor postmenopausal and not using adequate contraception Known sensitivity to mammalian cell derived drug products Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures Active substance abuse within 24 weeks of screening Requiring or having a condition that may be expected to require strong narcotic analgesics except hydrocodone, codeine, dextropropoxyphene, propoxyphene, or oxycodone or morphine derived medication for analgesic relief at screening.
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-refractory Prostate Cancer - Denosumab 20050147Prolonging bone metastasis-free survival in men with hormone-refractory androgen independent prostate cancerMedDRA version: 6.1Level: PTClassification code 10060862EUCTR2005-005485-37-ITAMGEN S.P.A.1,400
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 21.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866EUCTR2021-002006-27-FRovartis Pharma AG15,000
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2021-002006-27-DKovartis Pharma AG16,500
进行中（未招募）
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 21.1Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000004866EUCTR2021-002006-27-HUovartis Pharma AG15,000
招募中
1 期
A research study to find out whether a medicine called inclisiran helps to prevent cardiovascular death, heart attacks or strokes in people who already have vascular disease.Atherosclerotic cardiovascular disease (ASCVD)MedDRA version: 26.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 10047065 - Vascular disordersEUCTR2021-002006-27-ATovartis Pharma AG16,500