A Study of LY2127399 in Patients With Systemic Lupus Erythematosus

This study is currently recruiting participants.
Verified May 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01196091
First received: September 3, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in addition to standard of care therapy in patients with active SLE.


Condition Intervention Phase
Systemic Lupus Erythematosus
Connective Tissue Disease
Autoimmune Disease
Drug: LY2127399
Drug: Placebo every 2 weeks
Drug: Placebo every 4 weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Proportion of patients achieving an SLE Responder Index response at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients able to decrease dose of prednisone or equivalent with no increase in disease activity at week 52 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 weeks in anti-double stranded deoxyribonucleic acid (anti-dsDNA) level [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) score [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with no worsening in Physician Global Assessment (PGA) score at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in Brief Fatigue Inventory (BFI) scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint Lupus Quality of Life (LupusQoL) composite and domain scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Time to first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares [ Time Frame: Baseline through 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint in PGA [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with an increase in corticosteroids dose at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 weeks endpoint in SELENA-SLEDAI disease activity score [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients achieving a response as measured by modified SRI with no BILAG A or no more than 1 BILAG B organ domain flares at 52 weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 52 week endpoint BILAG numeric scores [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1140
Study Start Date: December 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2127399 every 2 weeks Drug: LY2127399
120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Experimental: LY2127399 every 4 wks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Drug: LY2127399
120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Drug: Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
Placebo Comparator: Placebo Drug: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
  • Have positive antinuclear antibodies (ANA)
  • Agree not to become pregnant throughout the course of the trial
  • Have the appropriate Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)score at screening

Exclusion Criteria:

  • Have active severe Lupus kidney disease
  • Have active Central Nervous System or peripheral neurologic disease
  • Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
  • Have active or recent infection within 30 days of screening
  • Have had a serious infection within 90 days of randomization
  • Have evidence or test positive for Hepatitis B
  • Have Hepatitis C
  • Are human immunodeficiency virus (HIV) positive
  • Have evidence of active or latent tuberculosis (TB)
  • Presence of significant laboratory abnormalities at screening
  • Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
  • Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
  • Have changed your dose of antimalarial drug in the past 30 days
  • Have changed your dose of immunosuppressive drug in the past 90 days
  • Have previously received rituximab
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196091

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Hide Study Locations
Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
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United States, Arizona
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Glendale, Arizona, United States, 85304
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Mesa, Arizona, United States, 85202
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Paradise Valley, Arizona, United States, 85253
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Peoria, Arizona, United States, 85381
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Phoenix, Arizona, United States, 85037
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United States, Arkansas
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Little Rock, Arkansas, United States, 72205
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United States, California
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Anaheim, California, United States, 92805
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Glendale, California, United States, 91204
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Lakewood, California, United States, 90712
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Long Beach, California, United States, 90808
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Los Angeles, California, United States, 90048
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Sacramento, California, United States, 95825
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San Leandro, California, United States, 94578
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Upland, California, United States, 91786
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United States, Connecticut
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Danbury, Connecticut, United States, 06810
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Farmington, Connecticut, United States, 06030
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Norwich, Connecticut, United States, 06360
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Trumbull, Connecticut, United States, 06611
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United States, Florida
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Boca Raton, Florida, United States, 33486
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Clearwater, Florida, United States, 33765
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Cutler Bay, Florida, United States, 33189
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Doral, Florida, United States, 33166
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Fort Lauderdale, Florida, United States, 33334
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Jacksonville, Florida, United States, 32216
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Lake Mary, Florida, United States, 32746
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Miami, Florida, United States, 33169
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Orange Park, Florida, United States, 32073
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Palm Harbor, Florida, United States, 34684
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St. Petersburg, Florida, United States, 33710
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Tamarac, Florida, United States, 33321
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Tampa, Florida, United States, 33612
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United States, Georgia
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Atlanta, Georgia, United States, 30342
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Decatur, Georgia, United States, 30033
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Marietta, Georgia, United States, 30060
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United States, Idaho
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Boise, Idaho, United States, 83702
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United States, Illinois
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Chicago, Illinois, United States, 60612
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Peoria, Illinois, United States, 61636
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United States, Indiana
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Muncie, Indiana, United States, 47304
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United States, Iowa
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Cedar Rapids, Iowa, United States, 52401
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United States, Kansas
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Kansas City, Kansas, United States, 66160
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United States, Kentucky
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Bowling Green, Kentucky, United States, 42101
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Lexington, Kentucky, United States, 40504
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United States, Maryland
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Baltimore, Maryland, United States, 21239
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Hagerstown, Maryland, United States, 21742
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Wheaton, Maryland, United States, 20902
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United States, Michigan
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Grand Rapids, Michigan, United States, 49546
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United States, Minnesota
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Eagan, Minnesota, United States, 55121
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United States, Missouri
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Florissant, Missouri, United States, 63031
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United States, Nebraska
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Lincoln, Nebraska, United States, 68516
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Omaha, Nebraska, United States, 68134
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United States, New Jersey
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Clifton, New Jersey, United States, 07012
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Teaneck, New Jersey, United States, 7666
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Toms River, New Jersey, United States, 08755
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United States, New Mexico
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Albuquerque, New Mexico, United States, 87102
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United States, New York
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Bronx, New York, United States, 10457
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Endwell, New York, United States, 13760
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Manhasset, New York, United States, 11030
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New York, New York, United States, 10019
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Rochester, New York, United States, 14618
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Syracuse, New York, United States, 13210
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United States, North Carolina
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Charlotte, North Carolina, United States, 28210
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Greenville, North Carolina, United States, 27834
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Hickory, North Carolina, United States, 28602
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United States, Ohio
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Cincinnati, Ohio, United States, 45229
Contact: Eli Lilly            
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Middleburg Heights, Ohio, United States, 44130
Contact: Eli Lilly            
United States, Oklahoma
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Edmond, Oklahoma, United States, 73013
Contact: Eli Lilly            
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Oklahoma City, Oklahoma, United States, 73103
Contact: Eli Lilly            
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
Contact: Eli Lilly            
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Pittsburgh, Pennsylvania, United States, 15217
Contact: Eli Lilly            
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Wexford, Pennsylvania, United States, 15090
Contact: Eli Lilly            
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Willow Grove, Pennsylvania, United States, 19090
Contact: Eli Lilly            
United States, Rhode Island
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East Providence, Rhode Island, United States, 02915
Contact: Eli Lilly            
United States, South Carolina
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Columbia, South Carolina, United States, 29204
Contact: Eli Lilly            
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Greenville, South Carolina, United States, 29601
Contact: Eli Lilly            
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North Charleston, South Carolina, United States, 29406
Contact: Eli Lilly            
United States, Tennessee
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Crossville, Tennessee, United States, 38555
Contact: Eli Lilly            
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Hixon, Tennessee, United States, 37343
Contact: Eli Lilly            
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Jackson, Tennessee, United States, 38305
Contact: Eli Lilly            
United States, Texas
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Allen, Texas, United States, 75013
Contact: Eli Lilly            
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Dallas, Texas, United States, 75390
Contact: Eli Lilly            
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Houston, Texas, United States, 77034
Contact: Eli Lilly            
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Irving, Texas, United States, 75061
Contact: Eli Lilly            
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Mesquite, Texas, United States, 75150
Contact: Eli Lilly            
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San Antonio, Texas, United States, 78229
Contact: Eli Lilly            
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Sugarland, Texas, United States, 77478
Contact: Eli Lilly            
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Waco, Texas, United States, 76708
Contact: Eli Lilly            
United States, Virginia
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Chesapeake, Virginia, United States, 23320
Contact: Eli Lilly            
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. Recruiting
Danville, Virginia, United States, 24541
Contact: Eli Lilly            
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. Recruiting
Richmond, Virginia, United States, 23294
Contact: Eli Lilly            
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. Recruiting
Williamsburg, Virginia, United States, 23185
Contact: Eli Lilly            
United States, Washington
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. Recruiting
Tacoma, Washington, United States, 98405
Contact: Eli Lilly            
United States, Wisconsin
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. Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Eli Lilly            
Argentina
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Buenos Aires, Argentina, C1417EYG
Contact: Eli Lilly            
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. Recruiting
Caba, Argentina, C1181ACH
Contact: Eli Lilly            
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. Recruiting
Córdoba, Argentina, X5016KEH
Contact: Eli Lilly            
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. Recruiting
Rosario, Argentina, S2000PBJ
Contact: Eli Lilly            
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San Juan, Argentina, 5400
Contact: Eli Lilly            
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. Recruiting
Tucuman, Argentina, 4000
Contact: Eli Lilly            
Austria
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Graz, Austria, 8036
Contact: Eli Lilly            
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. Recruiting
Vienna, Austria, A1090
Contact: Eli Lilly            
Belarus
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Brest, Belarus, 224027
Contact: Eli Lilly            
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. Recruiting
Grodno, Belarus, 230017
Contact: Eli Lilly            
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. Recruiting
Minsk, Belarus, 223041
Contact: Eli Lilly            
Bulgaria
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. Recruiting
Plovdiv, Bulgaria, 4002
Contact: Eli Lilly            
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. Recruiting
Sofia, Bulgaria, 1407
Contact: Eli Lilly            
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. Recruiting
Stara Zagora, Bulgaria, 6003
Contact: Eli Lilly            
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. Recruiting
Varna, Bulgaria, 9010
Contact: Eli Lilly            
Canada, British Columbia
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. Recruiting
Kelowna, British Columbia, Canada, V1Y3G5
Contact: Eli Lilly            
Canada, Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada, A1C2H5
Contact: Eli Lilly            
Canada, Ontario
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Markham, Ontario, Canada, L3P1A8
Contact: Eli Lilly            
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. Recruiting
Newmarket, Ontario, Canada, L3Y3R7
Contact: Eli Lilly            
Chile
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Osorno, Chile, 5290000
Contact: Eli Lilly            
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. Recruiting
Santiago, Chile, 7500000
Contact: Eli Lilly            
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. Recruiting
Valdivia, Chile
Contact: Eli Lilly            
Colombia
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. Recruiting
Bogota, Colombia
Contact: Eli Lilly            
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. Recruiting
Bucaramanga, Colombia, 681001
Contact: Eli Lilly            
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. Recruiting
Cali, Colombia
Contact: Eli Lilly            
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. Recruiting
Chia, Colombia
Contact: Eli Lilly            
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. Recruiting
Medellín, Colombia, 574
Contact: Eli Lilly            
Croatia
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. Recruiting
Osijek, Croatia, 31000
Contact: Eli Lilly            
Egypt
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. Recruiting
Al Minya, Egypt, 61111
Contact: Eli Lilly            
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. Recruiting
Alexandria, Egypt, 21131
Contact: Eli Lilly            
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. Recruiting
Cairo, Egypt, 941400
Contact: Eli Lilly            
Germany
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. Recruiting
Bad Nauheim, Germany, 61231
Contact: Eli Lilly            
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. Recruiting
Baden-Baden, Germany, 76530
Contact: Eli Lilly            
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. Recruiting
Berlin, Germany, 14059
Contact: Eli Lilly            
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. Recruiting
Erlangen, Germany, 91054
Contact: Eli Lilly            
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. Recruiting
Frankfurt, Germany, 60528
Contact: Eli Lilly            
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. Recruiting
Freiburg, Germany, 79106
Contact: Eli Lilly            
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. Recruiting
Hildesheim, Germany, 31134
Contact: Eli Lilly            
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. Recruiting
Jena, Germany, 07747
Contact: Eli Lilly            
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. Recruiting
Münster, Germany, 48149
Contact: Eli Lilly            
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. Recruiting
Rostock, Germany, 18059
Contact: Eli Lilly            
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. Recruiting
Würzburg, Germany, 97080
Contact: Eli Lilly            
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. Recruiting
Zerbst, Germany, 39261
Contact: Eli Lilly            
Guatemala
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. Recruiting
Guatemala, Guatemala, 1010
Contact: Eli Lilly            
Italy
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. Recruiting
Brescia, Italy, 25123
Contact: Eli Lilly            
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. Recruiting
Genova, Italy, 16132
Contact: Eli Lilly            
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. Recruiting
Milano, Italy, 20122
Contact: Eli Lilly            
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. Recruiting
Napoli, Italy, 80131
Contact: Eli Lilly            
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. Recruiting
Padova, Italy, 35128
Contact: Eli Lilly            
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. Recruiting
Palermo, Italy, 90127
Contact: Eli Lilly            
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. Recruiting
Rome, Italy, 00133
Contact: Eli Lilly            
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. Recruiting
Scafati, Italy, 84018
Contact: Eli Lilly            
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. Recruiting
Torino, Italy, 10128
Contact: Eli Lilly            
Japan
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. Recruiting
Aichi, Japan, 4600001
Contact: Eli Lilly            
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. Recruiting
Chiba, Japan, 284-0003
Contact: Eli Lilly            
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. Recruiting
Fukuoka, Japan, 807-8556
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Hokkaido, Japan, 060-8648
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Japan, Japan, 852-8501
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Miyagi, Japan, 980-8574
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Nagasaki, Japan, 856-8562
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Osaka, Japan, 530-8480
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Tokyo, Japan, 101-0062
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Korea, Republic of
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Bucheon, Korea, Republic of, 420-717
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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, 501-757
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Incheon, Korea, Republic of, 405-760
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Jeonju-Si, Korea, Republic of, 561712
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Seoul, Korea, Republic of, 143-729
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Suwon, Korea, Republic of, 443-721
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Macedonia, The Former Yugoslav Republic of
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Bitola, Macedonia, The Former Yugoslav Republic of, 7000
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Skopje, Macedonia, The Former Yugoslav Republic of, 1000
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Stip, Macedonia, The Former Yugoslav Republic of, 2000
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Peru
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Arequipa, Peru
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Chiclayo, Peru
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Lima, Peru, L41
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Lince, Peru, Lima14
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Piura, Peru
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Philippines
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Angeles City, Philippines, 2009
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Cebu, Philippines, 6000
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Davao City, Philippines, 8000
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Ermita, Philippines, 1000
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Espana, Philippines, 1008
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Iloilo City, Philippines, 5000
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Manila, Philippines, 1007
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Paranaque, Philippines
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Quezon City, Philippines, 1102
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Poland
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?Ód?, Poland, 94-017
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Bytom, Poland, 41-902
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Poznan, Poland, 61-397
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Sosnowiec, Poland, 41-200
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Warsaw, Poland, 02-507
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Wroc?Aw, Poland, 50-368
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Puerto Rico
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San Juan, Puerto Rico, 00918
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Santurce, Puerto Rico, 00909
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Singapore
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Singapore, Singapore, 258499
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Thailand
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Bangkok, Thailand, 10700
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Chiang Mai, Thailand, 50200
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Turkey
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Adana, Turkey, 01330
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Ankara, Turkey, 06500
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Konya, Turkey, 42001
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Ukraine
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Dnipropetrovsk, Ukraine, 49005
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Donetsk, Ukraine, 83114
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Ivano-Frankivsk, Ukraine, 76008
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Kharkiv, Ukraine, 61029
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Kryvyi Rih, Ukraine, 50056
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Kyiv, Ukraine, 1601
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Lviv, Ukraine, 79011
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Odesa, Ukraine, 65025
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Simferopol, Ukraine, 95017
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Ternopil, Ukraine, 46002
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Uzhorod, Ukraine, 88018
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Vinnytsya, Ukraine, 21018
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Zaporizhzhia, Ukraine, 69600
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Zhytomyr, Ukraine, 10002
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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 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01196091     History of Changes
Other Study ID Numbers: 13656, H9B-MC -BCDS
Study First Received: September 3, 2010
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Austria: Federal Office for Safety in Health Care
Belarus: Ministry of Health
Bulgaria: Ministry of Health
Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Egypt: Ministry of Health, Drug Policy and Planning Center
Germany: Ministry of Health
Guatemala: Ministry of Public Health and Social Assistance
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Ministry for Health, Welfare and Family Affairs
Macedonia: Ministry of Health
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Singapore: Health Sciences Authority
Thailand: Ministry of Public Health
Turkey: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Eli Lilly and Company:
Lupus
SLE
Systemic Lupus Erythematosis
autoimmune disease
LY2127399
Immune system disease

Additional relevant MeSH terms:
Autoimmune Diseases
Connective Tissue Diseases
Lupus Erythematosus, Systemic
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013