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A Moderate to Severe Rheumatoid Arthritis Study (RA-BEACON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01721044
Recruitment Status : Completed
First Posted : November 2, 2012
Results First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Placebo Drug: Baricitinib Drug: cDMARD Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo

Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24.

Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Drug: Placebo
Administered orally
Drug: cDMARD
Participants will continue to take background cDMARD therapy throughout study.
Experimental: Baricitinib 2 mg

Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050
Drug: cDMARD
Participants will continue to take background cDMARD therapy throughout study.
Experimental: Baricitinib 4 mg

Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.

Participants will continue to take background cDMARD therapy throughout study.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050
Drug: cDMARD
Participants will continue to take background cDMARD therapy throughout study.



Primary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg [ Time Frame: Week 12 ]
    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.


Secondary Outcome Measures :
  1. Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg [ Time Frame: Baseline, Week 12 ]
    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 were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

  2. Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg [ Time Frame: Baseline, Week 12 ]
    DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

  3. Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg [ Time Frame: Week 12 ]
    The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.

  4. Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg [ Time Frame: Week 12 ]
    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.

  5. Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg [ Time Frame: Baseline, Week 12 ]
    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 were averaged to calculate the HAQ-DI score. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

  6. Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg [ Time Frame: Baseline, Week 12 ]
    DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. DAS28 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*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

  7. Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg [ Time Frame: Week 12 ]
    The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.

  8. Percentage of Participants Achieving ACR20 Response [ Time Frame: Week 24 ]
    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. ACR20 Responder is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.

  9. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 12 and Week 24 ]
    ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 Responder is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.

  10. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 12 and Week 24 ]
    ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR70 Responder is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.

  11. Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Week 12 ]
    DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), ESR (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.

  12. Change From Baseline in Clinical Disease Activity Index Score [ Time Frame: Baseline, Week 24 ]
    The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.

  13. Change From Baseline in Measures of SDAI Score [ Time Frame: Baseline, Week 24 ]

    The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity.

    The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.


  14. Percentage of Participants Achieving ACR/EULAR Remission - Boolean Remission [ Time Frame: Week 24 ]
    The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.

  15. Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness [ Time Frame: Baseline, Week 24 ]
    Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

  16. Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 24 ]
    A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.

  17. Change From Baseline in Worst Joint Pain NRS [ Time Frame: Baseline, Week 24 ]
    Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.

  18. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale Scores [ Time Frame: Baseline, Week 12, Week 24 ]
    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 (Not at all) to 4 (Very much) for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.

  19. Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) [ Time Frame: Baseline, Week 12, Week 24 ]
    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 [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status.

  20. Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores [ Time Frame: Baseline, Week 12, Week 24 ]
    European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.

  21. Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores [ Time Frame: Baseline, Week 12, Week 24 ]
    The WPAI-RA participant questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.

  22. Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib [ Time Frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose. ]
  23. Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib [ Time Frame: Week 0 (Baseline): 15 min. post-dose, 1 hour post-dose. Week 4 (Day 28 ±2 days): 2 to 4 hours post-dose. Week 8 (Day 56 ±3 days): 4 to 6 hours post-dose. Week 12 (Day 84 ±3 days): Pre-dose. Week 24 (Day 168 ±5 days): Pre-dose. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
  • Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
  • Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (greater than or equal to) 1 times the upper limit of normal (ULN)
  • Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:

    • experienced insufficient efficacy or loss of efficacy
    • experienced intolerance of such treatment
  • Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (cDMARD) for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry

Exclusion Criteria:

  • Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
  • Are currently receiving corticosteroids at doses > (greater than) 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
  • Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
  • Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
  • Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
  • Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
  • Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
  • Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants with secondary Sjogren's syndrome are not excluded.)
  • Have a diagnosis of Felty's syndrome
  • Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
  • Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
  • Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
  • Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
  • Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
  • Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
  • Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
  • Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
  • Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
  • Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
  • Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
  • Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
  • Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
  • Have symptomatic herpes simplex at the time of study enrollment
  • Have evidence of active or latent tuberculosis (TB)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721044


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Locations
United States, Arizona
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Glendale, Arizona, United States, 85304
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Phoenix, Arizona, United States, 85023
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Tucson, Arizona, United States, 85724
United States, California
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Palo Alto, California, United States, 94304
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Upland, California, United States, 91786
United States, Connecticut
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Danbury, Connecticut, United States, 06810
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Trumbull, Connecticut, United States, 06611
United States, Delaware
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Lewes, Delaware, United States, 19958
United States, Florida
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Boynton Beach, Florida, United States, 33472
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Orlando, Florida, United States, 32806
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Tamarac, Florida, United States, 33321
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Tampa, Florida, United States, 33613
United States, Idaho
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Boise, Idaho, United States, 83702
United States, Indiana
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Indianapolis, Indiana, United States, 46260
United States, Michigan
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Lansing, Michigan, United States, 48910
United States, Missouri
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Saint Louis, Missouri, United States, 63117
United States, New Jersey
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Freehold, New Jersey, United States, 07728
United States, New York
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Albany, New York, United States, 12206
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Hartsdale, New York, United States, 10530
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Rochester, New York, United States, 14618
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
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Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
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Philadelphia, Pennsylvania, United States, 19152
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Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
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Myrtle Beach, South Carolina, United States, 29572
United States, Texas
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Nassau Bay, Texas, United States, 77058
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Webster, Texas, United States, 77508
United States, Virginia
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Chesapeake, Virginia, United States, 23320
United States, Washington
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Kennewick, Washington, United States, 99336
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Vancouver, Washington, United States, 98664
United States, Wisconsin
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Franklin, Wisconsin, United States, 53132
Argentina
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Buenos Aires, Argentina, C1015ABO
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Rosario, Argentina, 2000
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San Miguel De Tucuman, Argentina, T4000AXL
Australia, New South Wales
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Kogarah, New South Wales, Australia, 04266-010
Australia, Queensland
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Maroochydore, Queensland, Australia, 4558
Australia, Victoria
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Fitzroy, Victoria, Australia, 3065
Austria
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Graz, Austria, 8036
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Vienna, Austria, 1100
Belgium
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Brussels, Belgium, 1000
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Mons, Belgium, 7000
Canada, Ontario
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Toronto, Ontario, Canada, M5T 3L9
Denmark
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Frederiksberg, Denmark, 2000
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Glostrup, Denmark, 2600
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Odense, Denmark, 5000
France
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Montpellier, France, 34295
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Orleans, France, 45032
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Paris, France, 75679
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Rennes, France, 35056
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Tours, France, 3700
Germany
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Dresden, Germany, 01067
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Hamburg, Germany, 22081
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Heidelberg, Germany, 69120
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Würzburg, Germany, 97080
Greece
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Athens, Greece, 11527
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Heraklion, Greece, 71110
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Kifissia, Greece, 14561
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Larissa, Greece, 411 10
Israel
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Ashkelon, Israel, 78278
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Beer Yaakov, Israel, 70300
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Haifa, Israel, 34362
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
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Petah Tikva, Israel, 49100
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Tel Aviv, Israel, 64239
Italy
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Firenze, Italy, 50134
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Pisa, Italy, 56100
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Rome, Italy, 00100
Japan
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Chiba, Japan, 284-0003
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Fukuoka, Japan, 810-8563
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Hiroshima, Japan, 730-0017
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Hokkaido, Japan, 060-8648
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Japan, Japan, 275-8580
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Kagawa, Japan, 761-0793
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Kumamoto, Japan, 861-1196
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Nagasaki, Japan, 856-8562
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Okayama, Japan, 700-8607
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Saitama, Japan, 359-1111
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Tokyo, Japan, 104-8560
Korea, Republic of
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Seoul, Korea, Republic of, 110-744
Mexico
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Guadalajara, Mexico, 44650
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Mexico City, Mexico, 06090
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Monterrey, Mexico, 64040
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San Luis Potosi, Mexico, 78213
Netherlands
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Ubbergen, Netherlands, 6574 NA
Poland
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Gdansk, Poland, 80-546
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Nadarzyn, Poland, 05-830
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Warsaw, Poland, 02-507
Puerto Rico
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Caguas, Puerto Rico, 00725
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San Juan, Puerto Rico, 00927
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Santurce, Puerto Rico, 00909
Spain
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La Vila Joiosa, Spain, 03570
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Santander, Spain, 39008
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Sevilla, Spain, 41010
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Valencia, Spain, 46026
Switzerland
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Fribourg, Switzerland, 1708
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Lausanne, Switzerland, CH-1011
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Zürich, Switzerland, 8091
Turkey
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Edirne, Turkey, 22030
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Gaziantep, Turkey, 27310
United Kingdom
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North Shields, Tyneside, United Kingdom, NE29 8NH
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Bradford, West Yorkshire, United Kingdom, BD5 0NA
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01721044     History of Changes
Other Study ID Numbers: 14058
I4V-MC-JADW ( Other Identifier: Eli Lilly and Company )
First Posted: November 2, 2012    Key Record Dates
Results First Posted: January 18, 2018
Last Update Posted: January 18, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases