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A Rheumatoid Arthritis Study in Participants (FLEX O)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

LY2127399

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

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.
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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.
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

120 mg LY2127399

90 mg LY2127399

Placebo

Arm Description

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.

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: 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.

Outcomes

Primary Outcome Measures

Percentage of Participants With American College of Rheumatology 20% (ACR20) Response

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.

Secondary Outcome Measures

Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses

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.

Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)

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.

Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)

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.

Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)

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.

Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)

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.

Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)

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.

Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)

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.

Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)

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.

Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)

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.

Time to American College of Rheumatology 20% (ACR20) Response

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.

Probability of an ACR20 Response by 24 Weeks

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.

Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response

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.

Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores

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.

Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint

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.

Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts

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.

Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels

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.

Population Pharmacokinetics (PK)

Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.

Percentage of Participants Developing Anti-LY2127399 Antibodies

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).

Full Information

NCT ID

NCT01202760

First Posted

September 14, 2010

Last Updated

March 24, 2018

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01202760

Brief Title

A Rheumatoid Arthritis Study in Participants

Acronym

FLEX O

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with <20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title

120 mg LY2127399

Arm Type

Experimental

Arm Description

Arm Title

90 mg LY2127399

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

LY2127399

Other Intervention Name(s)

Tabalumab

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Percentage of Participants With American College of Rheumatology 20% (ACR20) Response

Description

Time Frame

Up to 24 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses

Description

Time Frame

Up to 24 weeks

Title

Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)

Description

Time Frame

Up to 24 weeks

Title

Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Description

Time Frame

Baseline, up to 24 weeks

Title

Time to American College of Rheumatology 20% (ACR20) Response

Description

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.

Time Frame

Baseline through 24 weeks

Title

Probability of an ACR20 Response by 24 Weeks

Description

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.

Time Frame

Baseline through 24 weeks

Title

Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response

Description

Time Frame

Up to 24 weeks

Title

Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts

Description

Time Frame

Baseline, up to 24 weeks

Title

Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels

Description

Time Frame

Baseline, up to 24 weeks

Title

Population Pharmacokinetics (PK)

Description

Population estimate of constant clearance as determined by population pharmacokinetics (PK) analysis. A 2-compartment model was used in PK modeling.

Time Frame

Baseline through 24 weeks

Title

Percentage of Participants Developing Anti-LY2127399 Antibodies

Description

Time Frame

Baseline through 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35216

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United States

Facility Name

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Paradise Valley

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Arizona

ZIP/Postal Code

85253

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United States

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Peoria

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Arizona

ZIP/Postal Code

85381

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United States

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Phoenix

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Arizona

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85018

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United States

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Scottsdale

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Arizona

ZIP/Postal Code

85251

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United States

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Tucson

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Arizona

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85704

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United States

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Hot Springs

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Arkansas

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71913

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United States

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Little Rock

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Arkansas

ZIP/Postal Code

72205

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United States

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San Diego

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California

ZIP/Postal Code

92103

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United States

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Torrance

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California

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90505

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United States

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Tustin

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California

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92780

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United States

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Whittier

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California

ZIP/Postal Code

90606

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United States

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Wildomar

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California

ZIP/Postal Code

92595

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United States

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Colorado Springs

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Colorado

ZIP/Postal Code

80910

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United States

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Lewes

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Delaware

ZIP/Postal Code

19958

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United States

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Aventura

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Florida

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33180

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United States

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DeBary

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Florida

ZIP/Postal Code

32713

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United States

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Palm Harbor

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Florida

ZIP/Postal Code

34684

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United States

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Pinellas Park

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Florida

ZIP/Postal Code

33781

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United States

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Saint Petersburg

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Florida

ZIP/Postal Code

33716

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United States

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Tamarac

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Florida

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33321

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United States

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Venice

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Florida

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34292

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United States

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Zephyrhills

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Florida

ZIP/Postal Code

33542

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United States

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Decatur

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Georgia

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30033

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United States

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Gainesville

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Georgia

ZIP/Postal Code

30501

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United States

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Lawrenceville

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Georgia

ZIP/Postal Code

30045

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United States

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Marietta

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Georgia

ZIP/Postal Code

30060

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United States

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Savannah

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Georgia

ZIP/Postal Code

31405

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United States

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Eagle

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Idaho

ZIP/Postal Code

83616

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United States

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Morton Grove

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Illinois

ZIP/Postal Code

60053

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United States

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Rockford

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Illinois

ZIP/Postal Code

61103

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United States

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Indianapolis

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Indiana

ZIP/Postal Code

46227

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United States

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Wichita

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Kansas

ZIP/Postal Code

67208

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United States

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Cumberland

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Maryland

ZIP/Postal Code

21502

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United States

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Hyannis

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Massachusetts

ZIP/Postal Code

02601

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United States

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Worcester

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Massachusetts

ZIP/Postal Code

01605

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United States

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Bingham Farms

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Michigan

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48025

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United States

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Saint Clair Shores

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Michigan

ZIP/Postal Code

48081

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United States

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Flowood

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Mississippi

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39232

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United States

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Jackson

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Mississippi

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39202

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United States

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Saint Louis

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Missouri

ZIP/Postal Code

63131

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United States

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Lincoln

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Nebraska

ZIP/Postal Code

68516

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United States

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Omaha

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Nebraska

ZIP/Postal Code

68134

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United States

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Las Vegas

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Nevada

ZIP/Postal Code

89123

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United States

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Albuquerque

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New Mexico

ZIP/Postal Code

87108

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United States

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Brooklyn

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New York

ZIP/Postal Code

11201

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United States

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Roslyn

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New York

ZIP/Postal Code

11576

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United States

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Syracuse

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New York

ZIP/Postal Code

13210

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United States

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Charlotte

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North Carolina

ZIP/Postal Code

28210

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United States

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Hickory

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North Carolina

ZIP/Postal Code

28601

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United States

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Raleigh

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North Carolina

ZIP/Postal Code

27609

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United States

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Cincinnati

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Ohio

ZIP/Postal Code

45242

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United States

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Oklahoma City

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Oklahoma

ZIP/Postal Code

73103

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United States

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Tulsa

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Oklahoma

ZIP/Postal Code

74135

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United States

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Bend

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Oregon

ZIP/Postal Code

97701

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United States

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Bethlehem

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Pennsylvania

ZIP/Postal Code

18017

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United States

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Limerick

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Pennsylvania

ZIP/Postal Code

19468

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United States

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Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152

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United States

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Pottstown

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Pennsylvania

ZIP/Postal Code

19464

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United States

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Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

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United States

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Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

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United States

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Greer

State/Province

South Carolina

ZIP/Postal Code

29650

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United States

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Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

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United States

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North Charleston

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South Carolina

ZIP/Postal Code

29406

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United States

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Knoxville

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Tennessee

ZIP/Postal Code

37909

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United States

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Memphis

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Tennessee

ZIP/Postal Code

38119

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United States

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Nashville

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Tennessee

ZIP/Postal Code

37205

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United States

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Austin

State/Province

Texas

ZIP/Postal Code

78731

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United States

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Dallas

State/Province

Texas

ZIP/Postal Code

75231

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United States

Facility Name

City

Lake Jackson

State/Province

Texas

ZIP/Postal Code

77566

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United States

Facility Name

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

X5016KEH

Country

Argentina

Facility Name

City

Mar Del Plata

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

City

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

04266-010

Country

Australia

Facility Name

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

City

Malvern East

ZIP/Postal Code

3145

Country

Australia

Facility Name

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

City

Plovdiv

ZIP/Postal Code

4003

Country

Bulgaria

Facility Name

City

Rousse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

City

Sevlievo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

City

Bogota

Country

Colombia

Facility Name

City

Medellin

Country

Colombia

Facility Name

City

Opatija

ZIP/Postal Code

51410

Country

Croatia

Facility Name

City

Rijeka

ZIP/Postal Code

HR-51000

Country

Croatia

Facility Name

City

Split

ZIP/Postal Code

21000

Country

Croatia

Facility Name

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

City

Kiskunhalas

ZIP/Postal Code

6400

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

City

Satoraljaujhely

ZIP/Postal Code

3980

Country

Hungary

Facility Name

City

Szikszo

ZIP/Postal Code

3800

Country

Hungary

Facility Name

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

City

Ahmedabad

ZIP/Postal Code

3800015

Country

India

Facility Name

City

Bangalore

ZIP/Postal Code

5600092

Country

India

Facility Name

City

Chennai

ZIP/Postal Code

600100

Country

India

Facility Name

City

Hyderabaad

ZIP/Postal Code

500033

Country

India

Facility Name

City

Jaipur

ZIP/Postal Code

302023

Country

India

Facility Name

City

Mysore

ZIP/Postal Code

570023

Country

India

Facility Name

City

Nellore

ZIP/Postal Code

524003

Country

India

Facility Name

City

New Delhi

ZIP/Postal Code

110 076

Country

India

Facility Name

City

Secunderabad

ZIP/Postal Code

500 003

Country

India

Facility Name

City

Surat

ZIP/Postal Code

560092

Country

India

Facility Name

City

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

City

Gunma

ZIP/Postal Code

370-0053

Country

Japan

Facility Name

City

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

650-0017

Country

Japan

Facility Name

City

Ibaragi

ZIP/Postal Code

316-0035

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

City

Kumamoto

ZIP/Postal Code

861-8520

Country

Japan

Facility Name

City

Mie

ZIP/Postal Code

514-1101

Country

Japan

Facility Name

City

Miyagi

ZIP/Postal Code

982-0032

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

390-8601

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

City

Nara

ZIP/Postal Code

634-0007

Country

Japan

Facility Name

City

Ohita

ZIP/Postal Code

874-0011

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

712-8044

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

City

Saga

ZIP/Postal Code

843-0393

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

337-0012

Country

Japan

Facility Name

City

Sapporo-Shi

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

420-8623

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

185-0012

Country

Japan

Facility Name

City

Tomakomai

ZIP/Postal Code

053-8567

Country

Japan

Facility Name

City

Busan

ZIP/Postal Code

602-715

Country

Korea, Republic of

Facility Name

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

City

Alytus

ZIP/Postal Code

62114

Country

Lithuania

Facility Name

City

Kaunas

ZIP/Postal Code

49475

Country

Lithuania

Facility Name

City

Klaipedos

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

City

Siauliai

ZIP/Postal Code

73231

Country

Lithuania

Facility Name

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

City

Batu Caves

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

City

Kuantan Pahang

ZIP/Postal Code

25100

Country

Malaysia

Facility Name

City

Perak

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

City

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

City

Aguascalientes

ZIP/Postal Code

20203

Country

Mexico

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44690

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21100

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

06100

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64000

Country

Mexico

Facility Name

City

Morelia

ZIP/Postal Code

58070

Country

Mexico

Facility Name

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Tlalpan

ZIP/Postal Code

14080

Country

Mexico

Facility Name

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

City

Rotorua

ZIP/Postal Code

3010

Country

New Zealand

Facility Name

City

Tauranga

ZIP/Postal Code

3140

Country

New Zealand

Facility Name

City

Timaru

Country

New Zealand

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-607

Country

Poland

Facility Name

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

01-192

Country

Poland

Facility Name

City

Brasov

ZIP/Postal Code

500365

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400130

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700656

Country

Romania

Facility Name

City

Ploiesti

ZIP/Postal Code

100337

Country

Romania

Facility Name

City

Barnaul

ZIP/Postal Code

656038

Country

Russian Federation

Facility Name

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

City

Nizhny Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

City

Novosibirsk

ZIP/Postal Code

630047

Country

Russian Federation

Facility Name

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

City

Stavropol

ZIP/Postal Code

355017

Country

Russian Federation

Facility Name

City

Bratislava

ZIP/Postal Code

84231

Country

Slovakia

Facility Name

City

Piestany

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

City

Benoni

ZIP/Postal Code

1500

Country

South Africa

Facility Name

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

City

Breyten

ZIP/Postal Code

2330

Country

South Africa

Facility Name

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

City

Durban

ZIP/Postal Code

4092

Country

South Africa

Facility Name

City

Limpopo

ZIP/Postal Code

0380

Country

South Africa

Facility Name

City

Pretoria

ZIP/Postal Code

0184

Country

South Africa

Facility Name

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

City

Westville

ZIP/Postal Code

3630

Country

South Africa

Facility Name

City

Colombo

Country

Sri Lanka

Facility Name

City

Galle

Country

Sri Lanka

Facility Name

City

Kalubowila

Country

Sri Lanka

Facility Name

City

Nugegoda

Country

Sri Lanka

Facility Name

City

Keelong

ZIP/Postal Code

333

Country

Taiwan

Facility Name

City

Kuei Shan Hsiang

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49008

Country

Ukraine

Facility Name

City

Donetsk

ZIP/Postal Code

83045

Country

Ukraine

Facility Name

City

Kharkiv

ZIP/Postal Code

61178

Country

Ukraine

Facility Name

City

Kiev

ZIP/Postal Code

04114

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

03151

Country

Ukraine

Facility Name

City

Odesa

ZIP/Postal Code

65026

Country

Ukraine

Facility Name

City

Poltava

ZIP/Postal Code

36038

Country

Ukraine

Facility Name

City

Simferopol

ZIP/Postal Code

95017

Country

Ukraine

Facility Name

City

Vinnytsya

ZIP/Postal Code

21018

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

A Rheumatoid Arthritis Study in Participants

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