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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/NCT01202760
Registration number
NCT01202760
Ethics application status
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
25/04/2018
Titles & IDs
Public title
A Rheumatoid Arthritis Study in Participants
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
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Secondary ID [1]
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H9B-MC-BCDO
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Secondary ID [2]
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12978
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Universal Trial Number (UTN)
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Trial acronym
FLEX O
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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
Treatment: Drugs - LY2127399
Treatment: Drugs - Placebo
Experimental: 120 mg LY2127399 - LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Experimental: 90 mg LY2127399 - LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Placebo Comparator: Placebo - Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
Treatment: Drugs: LY2127399
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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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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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
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Assessment method [1]
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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 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
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Timepoint [1]
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Up to 24 weeks
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Secondary outcome [1]
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Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses
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Assessment method [1]
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ACR Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR50 Responder: had >=50% improvement from baseline in both 68 tender joint (TJ) and 66 swollen joint (SJ) counts and >=50% improvement in at least 3/5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP. Percentage of Pt achieving ACR50 response=(number (No) of ACR50 responders/No of Pts treated)*100. ACR70 Responder: had >=70% improvement from baseline in both TJ and SJ counts and >=70% improvement in at least 3 of same 5 criteria for ACR50. Percentage of Pts achieving ACR70 response=(No of ACR70 responders/No of Pts treated)*100. All non-responders at Week 16 as well as all Pts who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
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Timepoint [1]
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Up to 24 weeks
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Secondary outcome [2]
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Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)
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Assessment method [2]
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ACR-N is a continuous measure of clinical, laboratory, and functional outcomes in rheumatoid arthritis that characterizes percentage of improvement in disease activity from baseline based on ACR core set. Percentage of improvement was truncated to range of -100 to 100 to minimize impact of outliers (greater values indicate greater percent improvement). This index was calculated as minimum of a) percentage of improvement in TJ count, b) percentage of improvement in SJ count, or c) third highest percentage of improvement of remaining 5 ACR core criteria: If >=3 components of the 5 ACR core criteria were missing, then c) was set to missing; if any of 3 components a), b), or c) were missing, then ACR-N was set to missing. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with treatment, region, tumor necrosis factor-inadequate responder treatment history, and disease-modifying anti-rheumatic drug (DMARD) background as fixed factors and baseline as a covariate.
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Timepoint [2]
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Up to 24 weeks
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Secondary outcome [3]
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Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)
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Assessment method [3]
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Tender joint count is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both is translated into a single tender-versus-nontender dichotomy. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [3]
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Baseline, up to 24 weeks
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Secondary outcome [4]
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Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)
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Assessment method [4]
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Swollen joint count is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [4]
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Baseline, up to 24 weeks
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Secondary outcome [5]
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Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)
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Assessment method [5]
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Participant's assessment of their current arthritis pain using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no pain) to 100 mm (worst possible pain). A decrease in pain score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [5]
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Baseline, up to 24 weeks
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Secondary outcome [6]
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Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)
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Assessment method [6]
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Participant's assessment of their current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [6]
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Baseline, up to 24 weeks
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Secondary outcome [7]
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Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)
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Assessment method [7]
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Physician's assessment of the participant's current arthritis disease activity using a visual analog scale (VAS) ranged from 0 millimeters (mm) (no arthritis activity) to 100 mm (extremely active arthritis). A decrease in disease activity score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [7]
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Baseline, up to 24 weeks
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Secondary outcome [8]
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Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)
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Assessment method [8]
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Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and participant global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [8]
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Baseline, up to 24 weeks
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Secondary outcome [9]
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Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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Assessment method [9]
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The HAQ-DI questionnaire assesses 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. A decrease in HAQ-DI score indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [9]
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Baseline, up to 24 weeks
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Secondary outcome [10]
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Time to American College of Rheumatology 20% (ACR20) Response
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Assessment method [10]
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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 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
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Timepoint [10]
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Baseline through 24 weeks
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Secondary outcome [11]
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Probability of an ACR20 Response by 24 Weeks
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Assessment method [11]
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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 68 tender and 66 swollen joint counts and >=20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), joint pain, and C-reactive protein (CRP). The Kaplan-Meier estimator was used to summarize time to ACR20 response over the Treatment Period (24 weeks). The time to American College of Rheumatology 20% (ACR20) response (in weeks) is calculated as:
(Date of the first postbaseline visit during the Treatment Period meeting ACR20 response criteria - Date of first injection of study treatment + 1) / 7.
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Timepoint [11]
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Baseline through 24 weeks
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Secondary outcome [12]
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Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response
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Assessment method [12]
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EULAR Responder index based on 28 joint count categorizes clinical response based on improvement since baseline in DAS28-CRP. Participants are categorized as EULAR responders or non-responders based on improvement of DAS28-CRP scores from baseline. EULAR28 responder is defined as either DAS28-CRP <=5.1 and DAS28-CRP change <-0.6; or DAS28-CRP >5.1 and DAS28-CRP change <-1.2. EULAR28 responder index is defined as good response: DAS28-CRP <=3.2 and DAS28-CRP change <-1.2; moderate response: DAS28-CRP change <-1.2 except cases defined in good response; or DAS28-CRP <=5.1 and DAS28-CRP change <-0.6 and >-1.2. EULAR Remission is defined as a DAS28-CRP score of <2.6.
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Timepoint [12]
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Up to 24 weeks
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Secondary outcome [13]
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Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
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Assessment method [13]
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The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical health [PCS]). Domain scores calculated by summing each item for each domain and transforming scores into 0-100 scale; higher scores indicated better health status. MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [13]
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Baseline, up to 24 weeks
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Secondary outcome [14]
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Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint
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Assessment method [14]
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CRP is an indicator of inflammation. A negative change indicated an improvement in the participant's condition. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [14]
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Baseline, up to 24 weeks
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Secondary outcome [15]
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Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts
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Assessment method [15]
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Cell-surface marker cluster designation (CD) 3 negative, CD20 positive (CD3-CD20+) defines total mature B cells. B-lymphocyte antigen CD20 is an activated-glycosylated phosphoprotein expressed on the surface of all mature B cells. Baseline B-cell count is determined by calculating the average of the 2 pretreatment B-cell counts obtained once during Days -28 through -7 and on Day 0. A positive or negative change indicated an increase or decrease, respectively in B-cell count. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [15]
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Baseline, up to 24 weeks
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Secondary outcome [16]
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Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels
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Assessment method [16]
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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 A (IgA), and immunoglobulin M (IgM) levels are reported. A negative change indicated a decrease in immunoglobulin levels. LS means were calculated using ANCOVA with treatment, region, tumor necrosis factor-inadequate responder treatment history, and DMARD background as fixed factors and baseline as a covariate.
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Timepoint [16]
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Baseline, up to 24 weeks
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Secondary outcome [17]
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Population Pharmacokinetics (PK)
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Assessment method [17]
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Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.
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Timepoint [17]
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Baseline through 24 weeks
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Secondary outcome [18]
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Percentage of Participants Developing Anti-LY2127399 Antibodies
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Assessment method [18]
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LY2127399 anti-drug antibodies (ADA) were assessed at baseline, 1, 4, 16, and 24 weeks. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)*100. Pts with treatment-emergent ADA were Pts who had any sample from baseline up to and through Week 24 that was a 4-fold increase (2-dilution increase) in immunogenicity titer over baseline titer, or Pts who tested negative at baseline and positive post-baseline (at titer of =1:20).
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Timepoint [18]
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Baseline through 24 weeks
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Eligibility
Key inclusion criteria
- Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
- Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal
to 20/100 millimeters (mm)
- If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at
randomization, must have been on a stable dose for at least 8 weeks prior to study
start.
- Women must not be pregnant, breastfeeding, or become pregnant during the study
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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
- Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
- Steroid injection or intravenous (IV) infusion in the last 6 weeks
- Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
- Use of biologic DMARD concurrently or recently
- History of a serious reaction to other biological DMARDs
- Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the
last 8 weeks
- Surgery on a joint or other major surgery less than 2 months prior to study start, or
plans to have joint surgery or major surgery during the study
- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition
except RA
- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer
within the past 5 years
- Received a live vaccine within the past 12 weeks (for example, vaccines for measles,
mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
- Hepatitis or human immunodeficiency virus (HIV)
- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months
or a serious bone or joint infection within 6 months
- Symptoms of herpes zoster or herpes simplex within the last month
- Active or latent tuberculosis (TB)
- Current symptoms of a serious disorder or illness
- Use of an investigational drug within the last month
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/01/2011
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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
1/07/2013
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Sample size
Target
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Accrual to date
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Final
1004
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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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. - Kogarah
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Recruitment hospital [2]
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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. - Herston
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Recruitment hospital [3]
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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. - Malvern East
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Recruitment postcode(s) [1]
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04266-010 - Kogarah
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3145 - Malvern East
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Delaware
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Florida
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Georgia
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Illinois
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Indiana
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Maryland
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Massachusetts
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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Mar Del Plata
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Rosario
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San Juan
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Argentina
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Funding & Sponsors
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Commercial sector/Industry
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Name
Eli Lilly and Company
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Ethics approval
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Summary
Brief summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the
treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic
drug (DMARD) therapy.
This study is comprised of 2 periods:
Period 1 - 24-week blinded treatment
Period 2 - 48-week post-treatment follow-up
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01202760
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01202760
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