EUCTR2009-014824-40-CZ进行中（未招募）不适用
An open label follow on study to evaluate the long-term safety, tolerability and efficacy of ART621 following fortnightly administration for 48 weeks in patients with rheumatoid arthritis concomitantly taking methotrexate.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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.Prior participation in an ART621 clinical trial for rheumatoid arthritis
- •2.Concomitant doses of methotrexate between 10-25mg/week, oral steroid = 10mg prednisone equivalent/day (if needed) and stable use of up to one concomitant NSAID (if needed)
- •3.Provision of a valid written informed consent.
- •4.Demonstrated tolerance of prior ART621 trial medications and procedures.
- •5.Demonstrated compliance with prior ART621 trial protocol requirements.
- •6.Is willing and able to comply with current study visits and other protocol requirements.
- •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.Pregnant, nursing or planning a pregnancy (both men and women) within the next 15 months.
- •2.Laboratory tests at Screen:
- •ohemoglobin = 8.0 gm/dl
- •owhite blood cells = 3.0 x103 cells/µl
- •oneutrophils = 1.5 x 103 cells/µl
- •oplatelets = 100 x 103 cells/µl
- •oserum transaminase level (AST and ALT) = 2 times upper limit of normal (ULN)
- •oserum creatinine = 0.15 mmol/l
- •3.Subjects diagnosed with inflammatory or autoimmune diseases that might confound the evaluations of benefit from ART621 such as ankylosing spondylitis, systemic lupus erythematosus and Lyme disease.
- •4.Subjects who may require plasmapheresis during the 48 week study period.
- •5.Subjects who have developed clinically significant adverse reaction to murine or chimeric proteins, including serious allergic reactions during or since participation in the previous ART621 study.
- •6.Subjects who are expected to receive any live virus or bacterial vaccinations during the 48 week study period.
- •7.Subjects with presence of, or at high risk of serious infection including:
- •otuberculosis
- •oa serious infection during the past 3 months (hospitalised or received IV antibiotics for an infection)
- •ochronic or recurrent infectious disease.
- •osystemic fungal infections
- •oopportunistic infection within the past 3 months (refer to 1993 CDC Classification System for HIV Infection)
- •oHIV, hepatitis B, or hepatitis C
- •osubjects with planned joint replacement surgery or a history of infected joint prosthesis or who have received antibiotics for a suspected infection of a joint prosthesis if that prosthesis has not been removed or replaced during the past 3 months
- •8.Subjects with contraindications to anti-TNF therapy including demyelinating diseases, congestive heart failure, evidence of malignancy, lymphoproliferative or neoplastic disease.
- •9.Subjects who have, or are at risk of developing, severe, progressive or uncontrolled concomitant medical conditions.
- •10.Subjects who have received cytotoxic drugs including cyclophosphamide, cyclosporine, or alkylating agents since commencement of the previous ART621 study or who will require such therapies during the current study.
- •11.Participation in any other investigational study during the 48 week study period.
- •12.Any other clinically significant disease or disorder or factors such as substance abuse which in the opinion of the investigator make the subject ineligible for participation in this study.
研究者
相似试验
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-CYIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyEUCTR2021-001427-40-FRIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-ESIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-SEIonis Pharmaceuticals, Inc.165
进行中（未招募）
1 期
Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyHereditary Transthyretin-Mediated Amyloid PolyneuropathyMedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850EUCTR2021-001427-40-PTIonis Pharmaceuticals, Inc.165