A Moderate to Severe Rheumatoid Arthritis Study

Last updated: September 9, 2019
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Musculoskeletal Diseases

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT01721044
14058
I4V-MC-JADW
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the AmericanCollege of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteriafor the Classification of RA

  • Have moderately to severely active RA defined as the presence of at least 6/68 tenderjoints 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, nonchangingdose for at least 8 weeks prior to study entry

Exclusion

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 ofprednisone (or equivalent) or have been receiving an unstable dosing regimen ofcorticosteroids within 2 weeks of study entry or within 6 weeks of plannedrandomization

  • Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or havebeen receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry orwithin 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 orintravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks priorto planned randomization or are anticipated to require parenteral injection ofcorticosteroids during the study

  • Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronicacid within 2 weeks prior to study entry or within 6 weeks prior to plannedrandomization

  • Have active fibromyalgia that, in the investigator's opinion, would make it difficultto appropriately assess RA activity for the purposes of this study

  • Have a diagnosis of any systemic inflammatory condition other than RA, such as, butnot limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,ulcerative colitis, psoriatic arthritis, active vasculitis or gout (participants withsecondary 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 surgeryduring the study that, in the opinion of the investigator in consultation with Lillyor its designee, would pose an unacceptable risk to the participant

  • Have experienced any of the following within 12 weeks of study entry: myocardialinfarction, unstable ischemic heart disease, stroke, or have New York HeartAssociation stage IV heart failure

  • Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal,endocrine, hematological, neurological, or neuropsychiatric disorders or any otherserious and/or unstable illness that, in the opinion of the investigator, couldconstitute a risk when taking investigational product or could interfere with theinterpretation of data

  • Are largely or wholly incapacitated permitting little or no self care, such as, beingbedridden or confined to a wheelchair

  • Have an estimated glomerular filtration rate (eGFR) based on the most recent availableserum 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 aspartateaminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or themost recent available total bilirubin ≥1.5 times the ULN

  • Have a history of, lymphoproliferative disease; or have signs or symptoms suggestiveof possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; orhave active primary or recurrent malignant disease; or have been in remission fromclinically significant malignancy for <5 years

  • Have been exposed to a live vaccine within 12 weeks prior to planned randomization orare expected to need/receive a live vaccine during the course of the study (with theexception of herpes zoster vaccination)

  • Have a current or recent clinically serious viral, bacterial, fungal, or parasiticinfection

  • Have had symptomatic herpes zoster infection within 12 weeks prior to study entry

  • Have a history of disseminated/complicated herpes zoster (eg, multidermatomalinvolvement, ophthalmic zoster, central nervous system involvement, postherpeticneuralgia)

  • Are immunocompromised and, in the opinion of the investigator, are at an unacceptablerisk for participating in the study

  • Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV)

  • Have screening laboratory test values, including thyroid-stimulating hormone (TSH),outside the reference range for the population or investigative site that, in theopinion of the investigator, pose an unacceptable risk for the participant'sparticipation in the study

  • Have screening electrocardiogram (ECG) abnormalities that, in the opinion of theinvestigator or the sponsor, are clinically significant and indicate an unacceptablerisk for the participant's participation in the study (e.g. Fridericia's corrected QTinterval >500 millisecond [msec])

  • Have symptomatic herpes simplex at the time of study enrollment

  • Have evidence of active or latent tuberculosis (TB)

Study Design

Total Participants: 527
Study Start date:
January 01, 2013
Estimated Completion Date:
September 30, 2014

Connect with a study center

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    Bahia Blanca, B8000HXM
    Argentina

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    Argentina

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    Argentina

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    Kogarah, New South Wales 04266-010
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    Athens, 11527
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    Heraklion, 71110
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    Afula, 18101
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    Beer Yaakov, 70300
    Israel

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    Haifa, 34362
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    Jerusalem, 91120
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    Kfar Saba, 44281
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    Petah Tikva, 49100
    Israel

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    Tel Aviv, 64239
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    Firenze, 50134
    Italy

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    Milano, 20122
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    Pisa, 56100
    Italy

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    Rome, 00100
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    Chiba, 284-0003
    Japan

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    Fukuoka, 810-8563
    Japan

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    Hiroshima, 730-0017
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    Hokkaido, 060-8648
    Japan

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    Hyogo, 673-1462
    Japan

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    Japan, 275-8580
    Japan

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    Kagawa, 761-0793
    Japan

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    Kumamoto, 861-1196
    Japan

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    Nagasaki, 856-8562
    Japan

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    Okayama, 700-8607
    Japan

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    Saitama, 359-1111
    Japan

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    Tokyo, 104-8560
    Japan

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    Daejeon, 302-799
    Korea, Republic of

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    Seoul, 110-744
    Korea, Republic of

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    Chihuahua, 06090
    Mexico

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    Guadalajara, 44650
    Mexico

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    Mexico City, 06090
    Mexico

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    Monterrey, 64040
    Mexico

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    San Luis Potosi, 78213
    Mexico

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    Almelo, 7609 PP
    Netherlands

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    Amsterdam, 1075 HN
    Netherlands

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    Nijmegen, 6500 HB
    Netherlands

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    Ubbergen, 6574 NA
    Netherlands

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    Bydgoszcz, 85-168
    Poland

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    Gdansk, 80-546
    Poland

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    Nadarzyn, 05-830
    Poland

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    Warsaw, 02-507
    Poland

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    Caguas, 00725
    Puerto Rico

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    San Juan, 00927
    Puerto Rico

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    Santurce, 00909
    Puerto Rico

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    Barcelona, 08025
    Spain

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    Bilbao, 48013
    Spain

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    Bilboa, 48013
    Spain

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    La Vila Joiosa, 03570
    Spain

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    Santander, 39008
    Spain

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    Sevilla, 41010
    Spain

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    Valencia, 46026
    Spain

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    Villajoyosa, 03570
    Spain

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    Fribourg, 1708
    Switzerland

    Site Not Available

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    Lausanne, CH-1011
    Switzerland

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    Villars-Sur-Glâne, 1752
    Switzerland

    Site Not Available

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    Zürich, 8091
    Switzerland

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    Adana, 1330
    Turkey

    Site Not Available

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    Ankara, 06100
    Turkey

    Site Not Available

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    Antalya, 07070
    Turkey

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    Denizli, 06111
    Turkey

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    Edirne, 22030
    Turkey

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    Eskisehir, 26480
    Turkey

    Site Not Available

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    Gaziantep, 27310
    Turkey

    Site Not Available

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    Istanbul, 34303
    Turkey

    Site Not Available

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    Manisa, 45030
    Turkey

    Site Not Available

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    Torquay, Cnwll TQ2 7AA
    United Kingdom

    Site Not Available

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    London, Greater London E11 1NR
    United Kingdom

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    North Shields, Tyneside NE29 8NH
    United Kingdom

    Site Not Available

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    Bradford, West Yorkshire BD5 0NA
    United Kingdom

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    Glendale, Arizona 85304
    United States

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    Peoria, Arizona 85381
    United States

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    Phoenix, Arizona 85023
    United States

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    Tucson, Arizona 85724
    United States

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    Fresno, California 93720
    United States

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    Palo Alto, California 94304
    United States

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    Upland, California 91786
    United States

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    Aurora, Colorado 80045
    United States

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    Denver, Colorado 80230
    United States

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    Longmont, Colorado 80501
    United States

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    Danbury, Connecticut 06810
    United States

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    Trumbull, Connecticut 06611
    United States

    Site Not Available

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    Lewes, Delaware 19958
    United States

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    Boynton Beach, Florida 33472
    United States

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    Naples, Florida 34102
    United States

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    Orlando, Florida 32806
    United States

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    Tamarac, Florida 33321
    United States

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    Tampa, Florida 33613
    United States

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    Boise, Idaho 83702
    United States

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    Indianapolis, Indiana 46260
    United States

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    Prairie Village, Kansas 66206
    United States

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    Grand Rapids, Michigan 49546
    United States

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    Kalamazoo, Michigan 48025
    United States

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    Lansing, Michigan 48910
    United States

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    Saint Louis, Missouri 63117
    United States

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    St Louis, Missouri 63117
    United States

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    Freehold, New Jersey 07728
    United States

    Site Not Available

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    Albany, New York 12206
    United States

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    Hartsdale, New York 10530
    United States

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    Rochester, New York 14618
    United States

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    Cincinnati, Ohio 45267
    United States

    Site Not Available

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    Columbus, Ohio 43210
    United States

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    Oklahoma City, Oklahoma 73103
    United States

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    Tulsa, Oklahoma 74135
    United States

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    Portland, Oregon 97239
    United States

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    Bethlehem, Pennsylvania 18017
    United States

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    Philadelphia, Pennsylvania 19152
    United States

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    Wyomissing, Pennsylvania 19610
    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.

    Myrtle Beach, South Carolina 29572
    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.

    Houston, Texas 77008
    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.

    Lubbock, Texas 79424
    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.

    Nassau Bay, Texas 77058
    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.

    Webster, Texas 77508
    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.

    Chesapeake, Virginia 23320
    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.

    Kennewick, Washington 99336
    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.

    Seattle, Washington 98133
    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.

    Vancouver, Washington 98664
    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.

    Franklin, Wisconsin 53132
    United States

    Site Not Available

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