EUCTR2014-000110-61-ES进行中（未招募）1 期
An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
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
- •_ Have completed all 24 weeks of study procedures (including dosing) according to protocol FKB32-002, with a minimum of 8 doses of study drug received, and are continuing with concomitant MTX and folate. _ In the investigator?s opinion, the patient showed a clinical response to treatment during Study FKB327-002.
- •_ Are willing to participate in the study and have provided written informed consent.
- •_ Females of childbearing potential must have a negative pregnancy test prior to study dosing.
- •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 510
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •_ Evidence of a serious adverse event (SAE) ongoing from Study FKB327-002 at entry to this study, including a serious infection, malignancy, or any other condition that may put patients at increased risk when receiving treatment with adalimumab.
- •_ Presence of active and/or untreated latent tuberculosis (TB) as detected by QuantiFERON test at Week 22 combined with chest X-ray at Week 24 in Study FKB327-002. Latent TB, treated with prophylactic anti mycobacterial therapy for at least 3 weeks before study dosing is resumed, is acceptable. Patients may have up to a maximum of 4 weeks interruption of dosing between the last dose in Study FKB327-002 and Week 0 dosing in study FKB327-003 for this purpose.
- •_ Were non compliant with FKB327-002 study procedures, or with any condition or circumstances, which, in the opinion of the Investigator, makes them unlikely or unable to comply with study procedures and requirements.
- •_ American College of Rheumatology (ACR) Functional Class IV.
研究者
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