A Study in Participants With Rheumatoid Arthritis

Last updated: May 11, 2018
Sponsor: Eli Lilly and Company
Overall Status: Terminated

Phase

3

Condition

Joint Injuries

Musculoskeletal Diseases

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT01202773
13732
H9B-MC-BCDV
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of RA of more than 6 months and less than 15 years

  • At least 8 tender and swollen joints

  • An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)

  • Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP)antibody

  • Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab,golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacyor intolerance

  • Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD),with a stable dose for at least 8 weeks prior to study start

  • Woman must not be pregnant, breastfeeding, or become pregnant during the study

Exclusion

Exclusion Criteria:

  • Use of unstable doses of non-steroidal anti-inflammatory drugs (NSAIDS) in the past 6weeks

  • Steroid injection or intravenous (IV) infusion in the last 6 weeks

  • Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks

  • History of a serious reaction to other biological DMARDs

  • Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in thelast 8 weeks

  • Surgery on a joint or other major surgery less than 2 months ago, or plans to havejoint surgery or major surgery during the study

  • Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,ulcerative colitis, psoriatic arthritis, or other systemic inflammatory conditionexcept RA

  • Cervical cancer or squamous skin cancer within the past 3 years, or other cancerwithin the past 5 years

  • Received a live vaccine received within the past 12 weeks (for example, vaccines formeasles, 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 monthsor 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

Study Design

Total Participants: 456
Study Start date:
January 01, 2011
Estimated Completion Date:
January 31, 2014

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    New Zealand

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    Rotorua, 3010
    New Zealand

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    Tauranga, 3140
    New Zealand

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    Timaru,
    New Zealand

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    Bydgoszcz, 85-168
    Poland

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    Elblag, 82-300
    Poland

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    Lublin, 20-607
    Poland

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    Plock, 09-400
    Poland

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    Torun, 87-100
    Poland

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    Warsaw, 02-118
    Poland

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    Kazan, 420029
    Russian Federation

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    Khanty-Mansiysk, 628012
    Russian Federation

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    Kursk, 305007
    Russian Federation

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    Moscow, 115093
    Russian Federation

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    Nizhny Novgorod, 603005
    Russian Federation

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    Petrozavodsk, 185019
    Russian Federation

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    Saint Petersburg, 191104
    Russian Federation

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    Stavropol, 355017
    Russian Federation

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    Voronezh, 394066
    Russian Federation

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    Benoni, 1500
    South Africa

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    Bloemfontein, 9301
    South Africa

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    Cape Town, 7540
    South Africa

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    Limpopo, 0380
    South Africa

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    Barcelona, 08034
    Spain

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    Bilboa, 48013
    Spain

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    Castellón, 12004
    Spain

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    La Coruña, 15006
    Spain

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    La Coruña, 15006
    Spain

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    Madrid, 28046
    Spain

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    Manises, 46940
    Spain

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    Málaga, 29010
    Spain

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    Oviedo, 33006
    Spain

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    Pamplona, 31008
    Spain

    Site Not Available

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    San Sebastian, 20014
    Spain

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    Santander, 39008
    Spain

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    Santiago De Compostela, 15706
    Spain

    Site Not Available

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    Sevilla, 41071
    Spain

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    Keelung, 204
    Taiwan

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    Taichung, 40705
    Taiwan

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    Taipei, 112
    Taiwan

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    Birmingham, Alabama 35216
    United States

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    Huntsville, Alabama 35810
    United States

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    Montgomery, Alabama 36117
    United States

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    Paradise Valley, Arizona 85253
    United States

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    Phoenix, Arizona 85018
    United States

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    Scottsdale, Arizona 85251
    United States

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    Tucson, Arizona 85712
    United States

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    Jonesboro, Arkansas 72401
    United States

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    Little Rock, Arkansas 72205
    United States

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    Escondido, California 92027
    United States

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    Fresno, California 93720
    United States

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    Hemet, California 92543
    United States

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    Huntington Beach, California 92646
    United States

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    La Mesa, California 91942
    United States

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    Loma Linda, California 92354
    United States

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    Long Beach, California 90808
    United States

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    Los Angeles, California 90022
    United States

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    Murrieta, California 92563
    United States

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    Sacramento, California 95825
    United States

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    San Diego, California 92108
    United States

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    Santa Monica, California 90404
    United States

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    Torrance, California 90505
    United States

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    Tustin, California 92780
    United States

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    Upland, California 91786
    United States

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    Whittier, California 90606
    United States

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    Wildomar, California 92595
    United States

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    Colorado Springs, Colorado 80910
    United States

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    Denver, Colorado 80209
    United States

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    Lewes, Delaware 19958
    United States

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    Aventura, Florida 33180
    United States

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    Boca Raton, Florida 33486
    United States

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    Boynton Beach, Florida 33472
    United States

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    DeBary, Florida 32713
    United States

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    Fort Myers, Florida 33916
    United States

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    Lake Mary, Florida 32746
    United States

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    Miami, Florida 33173
    United States

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    New Port Richey, Florida 34652
    United States

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    Palm Harbor, Florida 34684
    United States

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    Pinellas Park, Florida 33781
    United States

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    S. Miami, Florida 33143
    United States

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    Tamarac, Florida 33321
    United States

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    Tampa, Florida 33609
    United States

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    Venice, Florida 34292
    United States

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    Vero Beach, Florida 32960
    United States

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    West Palm Beach, Florida 33401
    United States

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    Atlanta, Georgia 30342
    United States

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    Decatur, Georgia 30033
    United States

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    Dunwoody, Georgia 30338
    United States

    Site Not Available

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    Gainesville, Georgia 30501
    United States

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    Marietta, Georgia 30060
    United States

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    Peachtree City, Georgia 30269
    United States

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    Stockbridge, Georgia 30281
    United States

    Site Not Available

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    Boise, Idaho 83702
    United States

    Site Not Available

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    Eagle, Idaho 83616
    United States

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    Idaho Falls, Idaho 83404
    United States

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    Peoria, Illinois 61636
    United States

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    Rock Island, Illinois 61201
    United States

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    Brownsburg, Indiana 46112
    United States

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    Evansville, Indiana 47714
    United States

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    Indianapolis, Indiana 46227
    United States

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    Bettendorf, Iowa 52722
    United States

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    Kansas City, Kansas 66160
    United States

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    Bowling Green, Kentucky 42101
    United States

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    Lexington, Kentucky 40504
    United States

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    Owensboro, Kentucky 42303
    United States

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    Monroe, Louisiana 71203
    United States

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    New Orleans, Louisiana 70121
    United States

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    Shreveport, Louisiana 71101
    United States

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    Wheaton, Maryland 20902
    United States

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    Haverhill, Massachusetts 01830
    United States

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    Mansfield, Massachusetts 02048
    United States

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    Worcester, Massachusetts 01605
    United States

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    Saint Clair Shores, Michigan 48081
    United States

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    St Clair Shores, Michigan 48081
    United States

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    Edina, Minnesota 55435
    United States

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    St. Paul, Minnesota 55104
    United States

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    Flowood, Mississippi 39232
    United States

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    Jackson, Mississippi 39202
    United States

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    Cape Girardeau, Missouri 63703
    United States

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    Florissant, Missouri 63031
    United States

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    Saint Louis, Missouri 63131
    United States

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    St Louis, Missouri 63131
    United States

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    Kalispell, Montana 59901
    United States

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    Omaha, Nebraska 68134
    United States

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    Las Vegas, Nevada 89128
    United States

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    Dover, New Hampshire 03820
    United States

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    Nashua, New Hampshire 03060
    United States

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    Berkeley Heights, New Jersey 07922
    United States

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    Clifton, New Jersey 07012
    United States

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    Albuquerque, New Mexico 87108
    United States

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    Brooklyn, New York 11201
    United States

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    Roslyn, New York 11576
    United States

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    Syracuse, New York 13210
    United States

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    Belmont, North Carolina 28012
    United States

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    Charlotte, North Carolina 28210
    United States

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    Greensboro, North Carolina 27408
    United States

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    Hickory, North Carolina 28601
    United States

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    Sanford, North Carolina 27330
    United States

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    Bismarck, North Dakota 58502
    United States

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    Cincinnati, Ohio 45242
    United States

    Site Not Available

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    Cleveland, Ohio 44109
    United States

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    Oklahoma City, Oklahoma 73104
    United States

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    Tulsa, Oklahoma 74104
    United States

    Site Not Available

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    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

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    Erie, Pennsylvania 16508
    United States

    Site Not Available

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    Limerick, Pennsylvania 19468
    United States

    Site Not Available

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    Wexford, Pennsylvania 15090
    United States

    Site Not Available

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    Pawtucket, Rhode Island 02860
    United States

    Site Not Available

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    Charleston, South Carolina 29425
    United States

    Site Not Available

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    Columbia, South Carolina 29204
    United States

    Site Not Available

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    Greenville, South Carolina 29601
    United States

    Site Not Available

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    Greer, South Carolina 29651
    United States

    Site Not Available

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    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

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    Taylors, South Carolina 29687
    United States

    Site Not Available

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    Hendersonville, Tennessee 37075
    United States

    Site Not Available

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    Knoxville, Tennessee 37909
    United States

    Site Not Available

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    Memphis, Tennessee 38119
    United States

    Site Not Available

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    Nashville, Tennessee 37205
    United States

    Site Not Available

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    Austin, Texas 78731
    United States

    Site Not Available

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    Houston, Texas 77008
    United States

    Site Not Available

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    Lubbock, Texas 79424
    United States

    Site Not Available

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    Mesquite, Texas 75150
    United States

    Site Not Available

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    Nassau Bay, Texas 77058
    United States

    Site Not Available

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    San Antonio, Texas 78217
    United States

    Site Not Available

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    Sugar Land, Texas 77478
    United States

    Site Not Available

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    Sugarland, Texas 77478
    United States

    Site Not Available

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    Burlington, Vermont 05401
    United States

    Site Not Available

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    Chesapeake, Virginia 23320
    United States

    Site Not Available

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    Danville, Virginia 24541
    United States

    Site Not Available

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    Richmond, Virginia 23225
    United States

    Site Not Available

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    Olympia, Washington 98502
    United States

    Site Not Available

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    Spokane, Washington 99204
    United States

    Site Not Available

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    Tacoma, Washington 98405
    United States

    Site Not Available

  • 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.

    Wenatchee, Washington 98801
    United States

    Site Not Available

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    Clarksburg, West Virginia 26301
    United States

    Site Not Available

  • 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.

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • 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.

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • 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.

    Racine, Wisconsin 53406
    United States

    Site Not Available

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