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Trial record 1 of 11 for:    RA BEAM
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A Study in Moderate to Severe Rheumatoid Arthritis (RA-BEAM)

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: NCT01710358
Recruitment Status : Completed
First Posted : October 19, 2012
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1307 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- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo

Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50.

At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52.

Participants continued to take background methotrexate (MTX) therapy throughout study.

Drug: Methotrexate
Administered orally

Drug: Adalimumab Placebo
Adalimumab placebo administered SC.

Drug: Baricitinib Placebo
Baricitinib placebo administered orally.

Experimental: Baricitinib

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50.

Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.

Participants continued to take background methotrexate (MTX) therapy throughout study.

Drug: Baricitinib
Administered orally
Other Name: LY 3009104

Drug: Methotrexate
Administered orally

Drug: Adalimumab Placebo
Adalimumab placebo administered SC.

Active Comparator: Adalimumab

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52.

Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.

Participants continued to take background methotrexate (MTX) therapy throughout study.

Drug: Adalimumab
Administered SC

Drug: Methotrexate
Administered orally

Drug: Baricitinib Placebo
Baricitinib placebo administered orally.




Primary Outcome Measures :
  1. Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) [ Time Frame: Week 12 ]
    ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "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 discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.


Secondary Outcome Measures :
  1. Change From Baseline in the Modified Total Sharp Score (mTSS) [ Time Frame: Baseline, Week 24 ]

    X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.

    The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.


  2. Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [ 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.

  3. Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP) [ Time Frame: Baseline, Week 12 ]
    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 Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). 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. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

  4. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response [ Time Frame: Week 12, Week 24, Week 52 ]

    ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, 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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.


  5. Change From Baseline in Clinical Disease Activity Index (CDAI) Score [ Time Frame: Baseline, Week 12, Week 24, Week 52 ]
    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.

  6. Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3 [ Time Frame: Week 12, Week 24, Week 52 ]
    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 VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.

  7. Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission [ Time Frame: Week 12, Week 24, Week 52 ]
    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.

  8. Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries [ Time Frame: Week 12 ]
    Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

  9. Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries [ Time Frame: Week 12 ]
    Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.

  10. Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries [ Time Frame: Week 12 ]
    Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.

  11. Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries [ Time Frame: Week 12 ]
    Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.

  12. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores [ Time Frame: Baseline, Week 12, Week 24, Week 52 ]
    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.

  13. 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, Week 52 ]
    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 or functioning.

  14. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores [ Time Frame: Baseline, Week 12, Week 24, Week 52 ]
    European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of 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.

  15. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) [ Time Frame: Baseline, Week 12, Week 24, Week 52 ]
    A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.

  16. Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores [ Time Frame: Baseline, Week 12, Week 24, Week 52 ]
    The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) 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. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.

  17. Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores [ Time Frame: Baseline, Week 24, Week 52 ]

    X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing.

    The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).


  18. Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib [ Time Frame: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose ]
  19. Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib [ Time Frame: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: 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, Older Adult)
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 ≥6 milligram per Liter (mg/L)
  • Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response.
  • Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status

Exclusion Criteria:

  • Are currently receiving corticosteroids at doses >10 mg of prednisone per day (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 MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease-modifying antirheumatic drugs (cDMARDs)
  • Are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry
  • Have received leflunomide in the 12 weeks prior to study entry
  • Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
  • Have ever received any biologic disease-modifying antirheumatic drugs (DMARD)
  • Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
  • Have received any parenteral corticosteroid administered by intramuscular or intravenous 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 any condition or contraindication for adalimumab that would preclude the participant from participating in this protocol
  • Have active fibromyalgia that 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 Sjögren's syndrome are not excluded)
  • Have a diagnosis of Felty's syndrome
  • Have had any major surgery within 8 weeks prior to 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 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 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, or 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
  • 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): NCT01710358


  Hide Study Locations
Locations
United States, Arizona
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States, 85304
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States, 85381
Valley Arthritis Care, LLC
Phoenix, Arizona, United States, 85023
University of Boards Regent
Tucson, Arizona, United States, 85724
United States, California
Valley Endocrine, Fresno
Fresno, California, United States, 93720
Desert Medical Advances
Palm Desert, California, United States, 92260
Pacific Arthritis Center
Santa Maria, California, United States, 93454
Inlande Rheumatology Clinical Trials
Upland, California, United States, 91786
United States, Colorado
Boulder Medical Center
Boulder, Colorado, United States, 80304
United States, Connecticut
Clinical Research Center of CT/NY
Danbury, Connecticut, United States, 06810
New England Research Associates
Trumbull, Connecticut, United States, 06611
United States, Delaware
Delaware Arthritis
Lewes, Delaware, United States, 19958
United States, Florida
Orthopedic Research Institute
Boynton Beach, Florida, United States, 33472
Jeffrey Alper, M.D.
Naples, Florida, United States, 34102
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States, 34652
Rheumatology Associates of Central Florida
Orlando, Florida, United States, 32806
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States, 33324
McIlwain Medical Group
Tampa, Florida, United States, 33613
United States, Indiana
Indiana University Health
Indianapolis, Indiana, United States, 46202
Diagnostic Rheumatology and Research
Indianapolis, Indiana, United States, 46227
Goldpoint Clinical Research LLC
Indianapolis, Indiana, United States, 46260
United States, Michigan
West Michigan Rheumatology
Grand Rapids, Michigan, United States, 49546
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, Nevada
Dr. George Timothy Kelly
Las Vegas, Nevada, United States, 89128
United States, New Jersey
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States, 07728
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, New York
Drug Trials of America
Hartsdale, New York, United States, 10530
United States, North Carolina
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Asheville, North Carolina, United States, 28803
United States, Ohio
Paramount Medical Research
Middleburg Heights, Ohio, United States, 44130
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73103
Healthcare Research Consultant
Tulsa, Oklahoma, United States, 74135
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
East Penn Rheumatology
Bethlehem, Pennsylvania, United States, 18017
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Carolina Rheumatology and Neurology Associates
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Pioneer Research Solutions
Houston, Texas, United States, 77008
Accurate Clinical Research
Houston, Texas, United States, 77084
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States, 79424
Accurate Clinical Research
Nassau Bay, Texas, United States, 77058
Accurate Clinical Research
Webster, Texas, United States, 77508
United States, Virginia
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States, 23320
United States, Washington
The Seattle Arthritis Clinic
Seattle, Washington, United States, 98133
Vancouver Clinic
Vancouver, Washington, United States, 98664
United States, Wisconsin
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States, 53132
Argentina
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.
Bahia Blanca, Argentina, B8000HXM
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Buenos Aires, Argentina, CBA 1419
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Caba, Argentina, C1440AAD
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Córdoba, Argentina, 5000
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Mar Del Plata, Argentina, B7600FZN
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Quilmes, Argentina, B1878DVC
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Rosario, Argentina, 2000
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San Fernando, Argentina, 1646
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San Juan, Argentina, 5400
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San Miguel De Tucuman, Argentina, T4000AXL
Belgium
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Brussel, Belgium, 1200
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Genk, Belgium, 3600
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Merksem, Belgium, 2170
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Mons, Belgium, 7000
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y3G8
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Victoria, British Columbia, Canada, V8V 3P9
Canada, Ontario
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Kitchener, Ontario, Canada, N2M 5N6
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St. Catherines, Ontario, Canada, L2N 7E4
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Toronto, Ontario, Canada, M5T 3L9
Canada, Quebec
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
China
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Beijing, China, 100044
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Bengbu, China, 233004
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Changsha, China, 410011
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Guang Zhou, China, 510630
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Hefei, China, 230022
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Jinan, China, 250012
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Shanghai, China, 200052
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Wu Han, China, 430030
Croatia
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Varazdin, Croatia, 42000
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Zagreb, Croatia, 10 000
Czechia
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Brno, Czechia, 61141
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Bruntal, Czechia, 79201
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Hustopece, Czechia, 693 01
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Ostrava - Trebovice, Czechia, 722 00
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Ostrava, Czechia, 702 00
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Pardubice, Czechia, 530 02
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Prague, Czechia, 128 50
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Uherske Hradiste, Czechia, 686 01
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Zlin, Czechia, 760 01
France
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Cahors Cedex 9, France, 46005
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Limoges, France, 87042
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Montpellier, France, 34295
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Nantes, France, 44093
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Orleans, France, 45032
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Paris, France, 75679
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Poitiers, France, 86021
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Strasbourg, France, 67098
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Thionville, France, 57100
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Tours, France, 37044
Germany
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Gommern, Germany, 39245
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Herne, Germany, 44649
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Köln, Germany, 50937
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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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Larissa, Greece, 41221
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Marousi, Greece, 14561
Hungary
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Budapest, Hungary, 1023
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Kiskunhalas, Hungary, 6400
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Nyiregyhaza, Hungary, 4400
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Szekesfehervar, Hungary, 8000
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Veszprem, Hungary, 8200
Japan
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Aichi, Japan, 450-0002
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Chiba, Japan, 284-0003
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Fukuoka, Japan, 814-0002
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Hiroshima, Japan, 730-0017
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Hokkaido, Japan, 063-0811
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Hyogo, Japan, 665-0827
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Ibaragi, Japan, 316-0015
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Ibaraki, Japan, 305-8576
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Iwate, Japan, 020-0034
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Japan, Japan, 275-8580
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Kagawa, Japan, 761-0793
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Kagoshima, Japan, 211-0063
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Kanagawa, Japan, 224-0041
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Kumamoto, Japan, 862-8655
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Mie, Japan, 510-0016
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Nagano, Japan, 380-8582
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Nagasaki, Japan, 850-0832
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Niigata, Japan, 957-0054
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Oita, Japan, 870-0823
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Okayama, Japan, 700-0013
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Okinawa, Japan, 901-0243
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Osaka, Japan, 545-0011
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Saga, Japan, 843-0393
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Saitama, Japan, 333-0833
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Shizuoka, Japan, 420-0821
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Tochigi, Japan, 329- 0498
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Tokyo, Japan, 160-8582
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Toyama, Japan, 933-0874
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Yamaguchi, Japan, 745-0824
Korea, Republic of
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Daegu, Korea, Republic of, 700-712
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Daejeon, Korea, Republic of, 301-721
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Gwangju, Korea, Republic of, 510-757
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Incheon, Korea, Republic of, 400-711
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Seoul, Korea, Republic of, 130-702
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Suwon-Si, Korea, Republic of, 443-721
Latvia
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Liepaja, Latvia, LV-3401
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Riga, Latvia, LV-1002
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Valmiera, Latvia, LV-4201
Lithuania
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Kaunas, Lithuania, LT-50128
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Klaipeda, Lithuania, LT-92288
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Siauliai, Lithuania, 76231
Mexico
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Guadalajara, Mexico, 44690
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Merida, Mexico, 97070
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Mexicali, Mexico, 21200
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Mexico, Mexico, 06600
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San Luis Potosi, Mexico, 78213
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Tijuana, Mexico, 22010
Poland
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Bydgoszcz, Poland, 85-168
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Elblag, Poland, 82-300
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Gdansk, Poland, 80-546
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Katowice, Poland, 40-084
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Lodz, Poland, 90-242
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Nadarzyn, Poland, 05-830
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Warszawa, Poland, 02-653
Portugal
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Lisbon, Portugal, 1050
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Porto, Portugal, 4200-319
Puerto Rico
Ramon L. Ortega Colon
Carolina, Puerto Rico, 00983
Office of Dr. Ramon Toro
San German, Puerto Rico, 00683
Mindful Medical Research
San Juan, Puerto Rico, 00918
Latin Clinical Trial Center
Santurce, Puerto Rico, 00909
Romania
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Bucharest, Romania, 10584
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Cluj-Napoca, Romania, 400006
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Constanta, Romania, 900591
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Lasi, Romania, 700661
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Oradea, Romania, 410028
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Targu Mures, Romania, 540136
Russian Federation
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Korolev, Russian Federation, 141060
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Moscow, Russian Federation, 115522
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Ryazan, Russian Federation, 390026
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Saint Petersburg, Russian Federation, 194291
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Saratov, Russian Federation, 410053
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Ulyanovsk, Russian Federation, 432063
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Yaroslavl, Russian Federation, 150003
Slovakia
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Bratislava, Slovakia, 84231
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Partizanske, Slovakia, 95801
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Spisska Nova Ves, Slovakia, 052 01
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Topolcany, Slovakia, 95501
Slovenia
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Ljubljana, Slovenia, 1000
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Maribor, Slovenia, 2000
South Africa
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Durban, South Africa, 4001
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Greenacres, South Africa, 6057
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Pinelands, South Africa, 7405
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Stellenbosch, South Africa, 7600
Spain
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Barcelona, Spain, 08025
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Bilbao, Spain, 48013
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Hospitalet De Llobregat, Spain, 08907
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Madrid, Spain, 28040
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Sabadell, Spain, 08208
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Santander, Spain, 39008
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Sevilla, Spain, 41010
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Valencia, Spain, 46026
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Villajoyosa, Spain, 03570
Switzerland
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Fribourg, Switzerland, 1708
Taiwan
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Kaohsiung City, Taiwan, 83301
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Neihu Taipei, Taiwan, 114
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Taichung City, Taiwan, 40201
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Taichung, Taiwan, 404
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Taipei, Taiwan, 10630
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Yongkang City, Taiwan, 71004
United Kingdom
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London, England, United Kingdom, SE1 9RT
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London, Greater London, United Kingdom, E11 1NR
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Basingstoke, Hampshire, United Kingdom, RG24 9NA
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Southampton, Hants, United Kingdom, SO16 6YD
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Aberdeen, Scotland, United Kingdom, AB25 2ZN
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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: NCT01710358     History of Changes
Other Study ID Numbers: 13978
I4V-MC-JADV ( Other Identifier: Eli Lilly and Company )
First Posted: October 19, 2012    Key Record Dates
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: July 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
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents