An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 63
- 主要终点
- Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
研究概览
简要总结
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have given written informed consent
- •Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
- •Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
排除标准
- •Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
- •Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
- •Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
研究组 & 干预措施
LY2127399
干预措施: LY2127399 (Biological)
结局指标
主要结局
Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
时间窗: Baseline through Week 112
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early \[early discontinuation (ED)\], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
次要结局
- Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)(Baseline, up to and through Week 52)
- Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)(Baseline, up to and through Week 52)
- Percentage of Participants Achieving ACR70 Response(Baseline, up to and through Week 52)
- Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)(Baseline, up to and through Week 52)
- Percentage of Participants Achieving ACR20 Response(Baseline, up to and through Week 52)
- Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)(Baseline, up to and through Week 52)
- Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores(Baseline, up to and through Week 52)
- Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts(Baseline, Weeks 52, 60, 72, 80, 88, and 100)
- Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set](Baseline, up to and through Week 52)
- Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set](Baseline, up to and through Week 52)
- Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)(Baseline, Weeks 52, 60, 72, 80, 88, and 100)
- Pharmacodynamics: Change From Baseline in Serum Immunoglobulin(Baseline, up to Week 52)
- Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)(Baseline, up to and through Week 52)
- Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set](Baseline, up to and through Week 52)
- ACR-N Response(Baseline, up to and through Week 52)
- Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score(Baseline, up to and through Week 52)
- Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)(Baseline, up to and through Week 52)
- Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52(Baseline, Week 52)
- Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies(Baseline, up to Week 52)
- Percentage of Participants ACR50 Response(Baseline, up to and through Week 52)
- Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline, up to Week 52)
- Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)(Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52) and post-study treatment follow-up (start of Week 53 or ED up to and through Week 112))