An Open Label Extension Study in Participants With Rheumatoid Arthritis
2018年3月24日 更新者：Eli Lilly and Company
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
研究概览
研究类型
介入性
注册 (实际的)
182
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3A 1M4
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Ontario
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Hamilton、Ontario、加拿大、N2M 5N6
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Kitchener、Ontario、加拿大、N2M 5N6
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Budapest、匈牙利、1023
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Esztergom、匈牙利、2500
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Kistarcsa、匈牙利、2143
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Szolnok、匈牙利、5000
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Lucknow、印度、226018
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Pune、印度、411001
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Secunderabad、印度、500003
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Chihuahua、墨西哥、31000
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Cuernavaca、墨西哥、62270
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Guadalajara、墨西哥、44100
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Mexico City、墨西哥、06700
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Monterrey、墨西哥、64000
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San Luis Potosi、墨西哥、78210
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Tampico、墨西哥、89000
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Vienna、奥地利、1100
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Campinas、巴西、13015-011
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Curitiba、巴西、80060-240
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Goiania、巴西、74605-050
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Porto Alegre、巴西、90610-970
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Setor Oeste/Goiania、巴西、74100-125
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Hildesheim、德国、31134
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Leipzig、德国、04103
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Santiago、智利
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Valdivia、智利
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Vina Del Mar、智利
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Liege、比利时、4000
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Bialystok、波兰、15-337
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Chelm Slaski、波兰、41-403
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Elblag、波兰、82-300
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Krakow、波兰、30-510
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Lubin、波兰、20-022
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Lublin、波兰、20-954
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Poznan、波兰、60-356
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Torun、波兰、87-100
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Warsaw、波兰、00-235
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Wroclaw、波兰、50-088
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San Juan、波多黎各、00918
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South Australia
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Elizabeth Vale、South Australia、澳大利亚、5112
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Brasov、罗马尼亚、500365
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Targu-Mures、罗马尼亚、540136
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Alabama
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Birmingham、Alabama、美国、35205
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Huntsville、Alabama、美国、35801
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Arizona
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Mesa、Arizona、美国、85208
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California
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Palm Desert、California、美国、92260
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Riverside、California、美国、92501
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Santa Maria、California、美国、93454
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Upland、California、美国、91786
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Florida
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Jupiter、Florida、美国、33458
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Vero Beach、Florida、美国、32960
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Zephyrhills、Florida、美国、33542
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Maryland
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Baltimore、Maryland、美国、21239
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Missouri
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Saint Louis、Missouri、美国、63141
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North Carolina
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Hickory、North Carolina、美国、28601
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Ohio
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Middleburg Heights、Ohio、美国、44130
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19152
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South Carolina
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Orangeburg、South Carolina、美国、29118
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Tennessee
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Memphis、Tennessee、美国、38119
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Texas
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Dallas、Texas、美国、75231
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Mesquite、Texas、美国、75150
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：LY2127399
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60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
大体时间：Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
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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)].
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Baseline through Week 52 (up to 48 weeks of treatment or ED and follow-up through Week 52)
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Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
大体时间：Baseline through Week 112
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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)].
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Baseline through Week 112
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
大体时间：Baseline, up to and through Week 52
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The number of tender and painful joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
Joints were assessed by pressure and joint manipulation on physical examination.
The participant was asked for pain sensations on these manipulations and the investigator watched for spontaneous pain reactions.
Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in tender joint count indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
大体时间：Baseline, up to and through Week 52
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The number of swollen joints was determined by examination of 28 joints (14 on each side) which included: the 2 shoulders, the 2 elbows, the 2 wrists, the 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees.
Joints were classified as either swollen or not swollen.
Swelling was defined as palpable fluctuating synovitis of the joint.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in swollen joint count indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
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Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
大体时间：Baseline, up to and through Week 52
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Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS), which ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in disease activity score indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
|
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Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
大体时间：Baseline, up to and through Week 52
|
Physician's assessment of disease activity using a VAS that ranged from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in disease activity score indicated an improvement in the participant's condition.
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Baseline, up to and through Week 52
|
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Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
大体时间：Baseline, up to and through Week 52
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The disability section of the health assessment questionnaire scored the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities.
Scores for each functional area, which ranged from 0 (no disability) to 3 (severe disability), were averaged to calculate HAQ-DI.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in HAQ-DI score indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
大体时间：Baseline, up to and through Week 52
|
Participant's assessment of joint pain using a VAS, which ranged from 0 mm (no pain) to 100 mm (worst possible pain).
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in joint pain indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
大体时间：Baseline, up to and through Week 52
|
CRP is an indicator of inflammation.
The percentage of change in CRP from baseline=[(post-baseline CRP-baseline CRP)/baseline CRP]*100.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A negative change indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants Achieving ACR20 Response
大体时间：Baseline, up to and through Week 52
|
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR20 Responder: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as non-responder imputation (NRI)/LOCF.
Baseline: the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants ACR50 Response
大体时间：Baseline, up to and through Week 52
|
ACR50 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR50 Responder: had ≥50% improvement from baseline in both tender and swollen joint counts and ≥50% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR50 response=(number of ACR50 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as NRI/LOCF.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants Achieving ACR70 Response
大体时间：Baseline, up to and through Week 52
|
ACR70 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
ACR70 Responder: had ≥70% improvement from baseline in both tender and swollen joint counts and ≥70% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
Percentage of participants achieving ACR70 response=(number of ACR70 responders/number of participants treated)*100.
Participants who discontinued from study prior to Week 52 were imputed as non-responders.
Participants who reached Week 52 but had ≥1 of 7 components missing had missing components imputed by LOCF.
This composite data imputation was denoted as NRI/LOCF.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
ACR-N Response
大体时间：Baseline, up to and through Week 52
|
The ACR-N Responder Index was a composite of clinical, laboratory, and functional measures of rheumatoid arthritis.
This index was defined as the lowest of either a) percent change in tender joint count, b) percent change in swollen joint count, or c) median percent change in 5 core ACR criteria: participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and CRP.
For example, a participant with an ACR-N of X had an improvement ≥X% in both tender and swollen joint counts and a median improvement ≥X% in the 5 criteria previously mentioned.
Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have an ACR assessment.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
大体时间：Baseline, up to and through Week 52
|
The FACIT Fatigue Scale was a brief participant-reported measure of fatigue and consisted of 13 items.
Scores ranged from 0 to 52, where higher scores indicated less fatigue.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
An increase in FACIT fatigue score indicated an improvement of the participant's condition.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
大体时间：Baseline, up to and through Week 52
|
The DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (milligrams per liter [mg/L]), and participant global assessment of his or her disease activity using a VAS (participant global VAS).
The DAS28 was calculated by using the following formula: DAS28-CRP=0.56*square
root(TJC28)+0.28*square
root(SJC28)+0.36*natural
log(CRP+1)+0.014*participant
global VAS+0.96.
Scores ranged from 1.0 to 9.4 where lower scores indicated less disease activity and remission is DAS28 <2.6.
Baseline was defined as the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
A decrease in DAS28 indicated an improvement in the participant's condition.
|
Baseline, up to and through Week 52
|
|
Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
大体时间：Baseline, up to and through Week 52
|
EULAR28 was defined by the participant's change from baseline in DAS28 score and the absolute DAS28 score achieved.
DAS28 consisted of composite score of the following: tender joint count, swollen joint count, CRP, and participant global assessment of his\her disease activity (participant global VAS).
EULAR28 categories included: No Response [improvement in DAS28 ≤0.6 units (u) or post-baseline DAS28 score >5.1 with improvement ≤1.2 u], Moderate Response (post-baseline DAS28 score ≤5.1 with improvement >0.6 u but <1.2 u or post-baseline DAS28 score >3.2 with improvement >1.2 u), and Good Response (post-baseline DAS28 score ≤3.2 with improvement >1.2 u).
Baseline was the last assessment prior to the participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
Percentage of participants=(number of participants with specific response/participants assessed)*100.
Displayed percentages may not add up to 100% because of rounding.
|
Baseline, up to and through Week 52
|
|
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
大体时间：Baseline, up to and through Week 52
|
SF-36 was a 36-item, health-related survey that assessed participant's quality of life on 8 domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health, mental health, social functioning, vitality and 2 component scores (mental and physical health).
Domain scores calculated by summing individual items for each domain and transforming scores into 0 to 100 scale; higher scores indicated better health status.
The mental component summary (MCS) score, based on SF-36 domains, consisted of social functioning, vitality, mental health, and role-emotional scales (range: 0 to 100).
The physical component summary (PCS) score, based on SF-36 domains, consisted of physical functioning, bodily pain, role-physical, and general health scales (range: 0 to 100).
Baseline: last assessment prior to participant's first dose of LY2127399 in Study H9B-MC-BCDG (NCT00689728), Study H9B-MC-BCDH (NCT00785928), or this study.
|
Baseline, up to and through Week 52
|
|
Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
大体时间：Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
B-lymphocyte antigen CD20+ is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in cell count.
|
Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
|
Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
大体时间：Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
Cell surface marker CD19, CD27, and immunoglobulin D (IgD) expression levels were used to define the various B cell subsets.
Cell surface markers were defined as being either present (+) or absent (-).
Peripheral blood B cell subsets included: mature naive cells (CD19+IgD+CD27-); immature/transitional cells (CD19+IgD-CD27-); switched memory (CD19+IgD-CD27+); and non-switched memory (CD19+IgD+CD27+).
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in cell count.
|
Baseline, Weeks 52, 60, 72, 80, 88, and 100
|
|
Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
大体时间：Baseline, up to Week 52
|
Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses.
Their normal blood levels indicate proper immune status.
Change from baseline serum immunoglobulin G (IgG), immunoglobulin M (IgM), and immunoglobulin A (IgA) levels are reported.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
A negative change indicated a decrease in immunoglobulin levels.
|
Baseline, up to Week 52
|
|
Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
大体时间：Baseline, Week 52
|
RF is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis.
Higher RF levels indicate an aggressive rheumatoid arthritis and a higher risk of joint damage.
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)].
A decrease in RF levels indicated an improvement in the participant's condition.
Results for the 60/120/60 mg LY2127399 treatment arm were not analyzed as the participant did not have a Week 52 RF level assessment.
|
Baseline, Week 52
|
|
Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
大体时间：Baseline, up to Week 52
|
Anti-CCP antibodies were measured using an enzyme-linked immunosorbent assay (ELISA) method.
In general, high levels of the antibody indicated an aggressive rheumatoid arthritis and a higher risk of joint damage.
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)].
A decrease in anti-CCP antibodies indicated an improvement in the participant's condition.
|
Baseline, up to Week 52
|
|
Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
大体时间：Baseline, up to Week 52
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assessed the rate at which red blood cells fell in a test tube.
Normal range was considered to be 0 to 20 or 0 to 30 millimeters per hour (mm/h), depending on the reference range used by the laboratory.
Higher scores indicated greater inflammation.
Percent change from baseline ESR=[(post-baseline ESR- baseline ESR)/baseline ESR]*100.
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)].
A decrease in ESR indicated an improvement in the participant's condition.
|
Baseline, up to Week 52
|
|
Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
大体时间：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)
|
The number of participants who had treatment-emergent or follow-up emergent anti-LY2127399 antibodies [anti-drug antibodies (ADA)] is reported.
Treatment-emergent was defined as participants who had any sample from baseline through Week 52 that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Follow-up emergent was defined as any sample during follow-up that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer.
The number of participants with baseline positive ADA data is also reported.
Baseline was defined as the last measurement prior to randomization to any treatment in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928).
|
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)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Who Died, Any Cause
大体时间：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 72 and start of Week 73 up to and through Week 112)
|
A summary of serious 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)].
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, the post-study treatment follow-up started immediately afterwards.
After treatment discontinuation, participants could be followed beyond Week 72 for B cell recovery (up to Week 112).
|
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 72 and start of Week 73 up to and through Week 112)
|
合作者和调查者
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调查人员
- 研究主任：Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST)、Eli Lilly and Company
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年2月1日
初级完成 (实际的)
2011年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2009年2月3日
首先提交符合 QC 标准的
2009年2月3日
首次发布 (估计)
2009年2月5日
研究记录更新
最后更新发布 (实际的)
2018年4月25日
上次提交的符合 QC 标准的更新
2018年3月24日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.