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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00837811
Registration number
NCT00837811
Ethics application status
Date submitted
3/02/2009
Date registered
5/02/2009
Date last updated
25/04/2018
Titles & IDs
Public title
An Open Label Extension Study in Participants With Rheumatoid Arthritis
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Scientific title
An Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.
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Secondary ID [1]
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H9B-MC-BCDI
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Secondary ID [2]
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11768
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - LY2127399
Experimental: LY2127399 -
Other interventions: LY2127399
60 milligrams [(mg) with potential for dose escalation to 120 mg] subcutaneously every 4 weeks for 48 weeks
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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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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Timepoint [1]
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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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Primary outcome [2]
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Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs
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Assessment method [2]
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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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Timepoint [2]
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Baseline through Week 112
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Secondary outcome [1]
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Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set]
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Assessment method [1]
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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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Timepoint [1]
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Baseline, up to and through Week 52
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Secondary outcome [2]
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Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set)
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Assessment method [2]
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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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Timepoint [2]
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Baseline, up to and through Week 52
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Secondary outcome [3]
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Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set)
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Assessment method [3]
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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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Timepoint [3]
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Baseline, up to and through Week 52
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Secondary outcome [4]
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Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set)
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Assessment method [4]
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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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Timepoint [4]
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Baseline, up to and through Week 52
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Secondary outcome [5]
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Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set]
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, up to and through Week 52
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Secondary outcome [6]
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Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, up to and through Week 52
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Secondary outcome [7]
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Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set]
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, up to and through Week 52
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Secondary outcome [8]
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Percentage of Participants Achieving ACR20 Response
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, up to and through Week 52
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Secondary outcome [9]
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Percentage of Participants ACR50 Response
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, up to and through Week 52
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Secondary outcome [10]
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Percentage of Participants Achieving ACR70 Response
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, up to and through Week 52
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Secondary outcome [11]
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ACR-N Response
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, up to and through Week 52
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Secondary outcome [12]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, up to and through Week 52
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Secondary outcome [13]
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Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, up to and through Week 52
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Secondary outcome [14]
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Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28)
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline, up to and through Week 52
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Secondary outcome [15]
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, up to and through Week 52
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Secondary outcome [16]
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Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Weeks 52, 60, 72, 80, 88, and 100
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Secondary outcome [17]
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Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts)
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Weeks 52, 60, 72, 80, 88, and 100
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Secondary outcome [18]
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Pharmacodynamics: Change From Baseline in Serum Immunoglobulin
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, up to Week 52
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Secondary outcome [19]
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Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, Week 52
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Secondary outcome [20]
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Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline, up to Week 52
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Secondary outcome [21]
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Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline, up to Week 52
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Secondary outcome [22]
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Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies)
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Assessment method [22]
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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).
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Timepoint [22]
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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)
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
182
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Elizabeth Vale
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Recruitment postcode(s) [1]
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5112 - Elizabeth Vale
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Maryland
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Missouri
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Country [7]
0
0
United States of America
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State/province [7]
0
0
North Carolina
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Ohio
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Pennsylvania
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Country [10]
0
0
United States of America
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State/province [10]
0
0
South Carolina
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Tennessee
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Country [12]
0
0
United States of America
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Funding & Sponsors
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Eli Lilly and Company
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Summary
Brief summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections
for 48 weeks in participants with Rheumatoid Arthritis
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00837811
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Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UCT/GMT-5 hours, EST)
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00837811
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