Trial record 1 of 2 for:    NCT01205438
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A Study of LY2127399 in Patients With Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01205438
First received: September 17, 2010
Last updated: February 27, 2014
Last verified: February 2014
  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 ]
  • Change from baseline to 52 week endpoint in Physician's Global Assessment (PGA) [ 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 ]
  • 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 ]
  • 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 ]
  • 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 Safety of Estrogens in Lupus Erythematosus National Assessment- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) disease activity score [ Time Frame: Baseline, 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 ]
  • Proportion of patients achieving a response as measured by modified SLE Responder Index (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 ]

Estimated Enrollment: 1140
Study Start Date: January 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2127399 every 2 weeks Drug: LY2127399
120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
Experimental: LY 2127399 every 4 weeks
During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks.
Drug: LY2127399
120mg 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 as defined 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 (SLE) 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205438

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United States, Alabama
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Anniston, Alabama, United States, 36207
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Birmingham, Alabama, United States, 35216
United States, Arizona
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Gilbert, Arizona, United States, 85234
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Scottsdale, Arizona, United States, 85258
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Tempe, Arizona, United States, 85282
United States, Arkansas
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Malvern, Arkansas, United States, 72104
United States, California
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Covina, California, United States, 91723
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El Cajon, California, United States, 92020
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Escondido, California, United States, 92027
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Van Nuys, California, United States, 91405
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Whittier, California, United States, 90606
United States, Colorado
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Aurora, Colorado, United States, 80045
United States, District of Columbia
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Washington, District of Columbia, United States, 20060
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Debary, Florida, United States, 32713
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United States, Georgia
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Lithonia, Georgia, United States, 30038
United States, Idaho
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Meridian, Idaho, United States, 83642
United States, Illinois
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Rockford, Illinois, United States, 61107
United States, Indiana
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Fort Wayne, Indiana, United States, 46804
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Granger, Indiana, United States, 46530
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Indianapolis, Indiana, United States, 46202
United States, Louisiana
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Monroe, Louisiana, United States, 71203
United States, Maine
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Portland, Maine, United States, 04102
United States, Maryland
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Cumberland, Maryland, United States, 21502
United States, Michigan
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St Clair Shores, Michigan, United States, 48081
United States, Minnesota
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United States, Mississippi
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Hattiesburg, Mississippi, United States, 39402
United States, Missouri
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United States, Nevada
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United States, New Hampshire
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United States, New Jersey
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United States, New Mexico
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United States, New York
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Roslyn, New York, United States, 11576
United States, North Carolina
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Chapel Hill, North Carolina, United States, 27599
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Charlotte, North Carolina, United States, 28204
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Raleigh, North Carolina, United States, 27617
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Rocky Mount, North Carolina, United States, 27804
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44109
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Toledo, Ohio, United States, 43606
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
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Charleston, South Carolina, United States, 29425
United States, Tennessee
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Cookeville, Tennessee, United States, 38501
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Knoxville, Tennessee, United States, 37909
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Memphis, Tennessee, United States, 38163
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Nashville, Tennessee, United States, 37203
United States, Texas
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Amarillo, Texas, United States, 79124
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Austin, Texas, United States, 78745
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Nassau Bay, Texas, United States, 77058
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Round Rock, Texas, United States, 78665
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San Antonio, Texas, United States, 78232
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Victoria, Texas, United States, 77901
United States, Utah
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St. George, Utah, United States, 84790
United States, Washington
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Seattle, Washington, United States, 98104
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Spokane, Washington, United States, 99204
United States, West Virginia
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Clarksburg, West Virginia, United States, 26301
Australia, New South Wales
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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Cairns, Queensland, Australia, 4870
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Maroochydore, Queensland, Australia, 4558
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Heidelberg, Victoria, Australia, 3081
Australia
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Malvern East, Australia, 3145
Brazil
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Campinas, Brazil, 13015-011
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Goiania, Brazil, 74110-120
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Juiz De Fora, Brazil, 36010-570
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Porto Alegre, Brazil, 91350-200
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Salvador, Brazil, 40050-410
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São Paulo, Brazil, 04039-901
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
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Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Ecuador
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Cuenca, Ecuador, EC010150
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Guayaquil, Ecuador, 90110321
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Quito, Ecuador, 17
France
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Orleans, France, 45000
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Strasbourg, France, 67091
Hungary
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Budapest, Hungary, 1027
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Debrecen, Hungary, 4032
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Gyor, Hungary, 9023
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Gyula, Hungary, 5700
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Szeged, Hungary, 6720
India
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Bangalore, India, 560043
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Gujarat, India, 380015
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Haryana, India, 122001
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Hyderabaad, India, 500082
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Kormangala, India, 560034
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Pune, India, 411007
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Trivandrum, India, 695011
Israel
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Haifa, Israel, 34362
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Kfar Saba, Israel, 44281
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Petah Tikva, Israel, 49100
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Tel Hashomer, Israel, 52651
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Zerifin, Israel, 70300
Latvia
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Riga, Latvia, LV-1002
Malaysia
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Kota Kinabalu, Malaysia, 88586
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Kuala Lumpur, Malaysia, 59100
Mexico
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Guadalajara, Mexico, 44650
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Merida, Mexico, 97130
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Mexico City, Mexico, 06090
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San Luis, Mexico, 78240
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San Luis Potosi, Mexico, 78200
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Tijuana, Mexico, 22010
New Zealand
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Hamilton, New Zealand, 3204
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Otahuhu, New Zealand, 1640
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Takapuna, New Zealand, 622
Romania
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Brasov, Romania, 500283
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Bucharest, Romania, 020475
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Cluj-Napoca, Romania, 400006
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Galati, Romania, 800587
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Iasi, Romania, 700656
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Targu Mures, Romania, 540136
Russian Federation
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Chelyabinsk, Russian Federation, 454076
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Ekaterinburg, Russian Federation, 620012
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Kazan, Russian Federation, 420097
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Kemerovo, Russian Federation, 650099
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Moscow, Russian Federation, 125101
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Orenburg, Russian Federation, 460018
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Saint Petersburg, Russian Federation, 197089
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Tomsk, Russian Federation, 634063
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Yaroslavl, Russian Federation, 150023
Serbia
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Belgrade, Serbia, 11000
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Kragujevac, Serbia, 34000
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Niska Banja, Serbia, 18205
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Novi Sad, Serbia, 21000
South Africa
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Cape Town, South Africa, 7925
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Durban, South Africa, 4001
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Stellenbosch, South Africa, 7600
Spain
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Barcelona, Spain, 08035
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Bilbao, Spain, 48013
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La Coruña, Spain, 15006
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Las Palmas De Gran Canaria, Spain, 35010
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Madrid, Spain, 28040
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Málaga, Spain, 29010
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Santiago De Compostela, Spain, 15706
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Sevilla, Spain, 41071
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Vigo, Spain, 36200
Taiwan
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Changhua, Taiwan, 500
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Hualien, Taiwan, 970
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Kaohsiung, Taiwan, 833
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Taichung, Taiwan, 40705
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Taichung City, Taiwan, 40201
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Taipei, Taiwan, 10630
Tunisia
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La Marsa, Tunisia, 2070
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Monastir, Tunisia, 5000
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Sfax, Tunisia, 3029
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Sousse, Tunisia, 4000
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Tunis, Tunisia, 1008
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Tunis Monfleury, Tunisia, 1008
United Kingdom
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Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
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Poole, Dorset, United Kingdom, BH15 2JB
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London, Greater London, United Kingdom, E11 1NR
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Maidstone, Kent, United Kingdom, ME16 9QQ
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.
Wigan, Lancashire, United Kingdom, WN6 0LW
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.
London, United Kingdom, SE1 7EH
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: NCT01205438     History of Changes
Other Study ID Numbers: 13653, H9B-MC-BCDT
Study First Received: September 17, 2010
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Brazil: Ministry of Health
Canada: Health Canada
Ecuador: Public Health Ministry
France: Ministry of Health
Hungary: National Institute of Pharmacy
India: Ministry of Health
Israel: Ministry of Health
Latvia: Institutional Review Board
Malaysia: Ministry of Health
Mexico: Ministry of Health
Morocco: Ministry of Public Health
New Zealand: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia: Ethics Committee
South Africa: Department of Health
Spain: Ministry of Health
Taiwan: Department of Health
Tunisia: Ministry of Public Health

Keywords provided by Eli Lilly and Company:
SLE
Systemic Lupus Erythematosis
Lupus
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 July 24, 2014