Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1004 participants
INTERVENTIONAL
2011-01-31
2013-07-31
Brief Summary
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This study is comprised of 2 periods:
Period 1 - 24-week blinded treatment
Period 2 - 48-week post-treatment follow-up
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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120 mg LY2127399
LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment.
During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks.
After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
LY2127399
Placebo
90 mg LY2127399
LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment.
After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
LY2127399
Placebo
Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment.
After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period.
LY2127399
Placebo
Interventions
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LY2127399
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
* If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
* Women must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria
* Steroid injection or intravenous (IV) infusion in the last 6 weeks
* Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
* Use of biologic DMARD concurrently or recently
* History of a serious reaction to other biological DMARDs
* Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
* Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study
* Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
* Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
* Received a live vaccine within the past 12 weeks (for example, vaccines for measles, 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 months or 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Birmingham, Alabama, United States
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Paradise Valley, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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San Diego, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Whittier, California, United States
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Wildomar, California, United States
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Colorado Springs, Colorado, United States
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Lewes, Delaware, United States
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Aventura, Florida, United States
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DeBary, Florida, United States
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Palm Harbor, Florida, United States
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Pinellas Park, Florida, United States
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St. Petersburg, Florida, United States
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Tamarac, Florida, United States
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Venice, Florida, United States
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Zephyrhills, Florida, United States
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Decatur, Georgia, United States
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Gainesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
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Savannah, Georgia, United States
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Eagle, Idaho, United States
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Morton Grove, Illinois, United States
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Rockford, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Cumberland, Maryland, United States
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Hyannis, Massachusetts, United States
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Worcester, Massachusetts, United States
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Bingham Farms, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Flowood, Mississippi, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Roslyn, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Limerick, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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North Charleston, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Lake Jackson, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Nassau Bay, Texas, United States
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North Richland Hills, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Spokane, Washington, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Kogarah, New South Wales, Australia
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Herston, Queensland, Australia
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Malvern East, , Australia
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Burgas, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Bogotá, , Colombia
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Medellín, , Colombia
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Opatija, , Croatia
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Rijeka, , Croatia
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Split, , Croatia
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Budapest, , Hungary
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Debrecen, , Hungary
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Kiskunhalas, , Hungary
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Nyíregyháza, , Hungary
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Sátoraljaújhely, , Hungary
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Szikszó, , Hungary
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Veszprém, , Hungary
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Ahmedabad, , India
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Bangalore, , India
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Chennai, , India
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Hyderabaad, , India
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Jaipur, , India
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Mysore, , India
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Nellore, , India
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New Delhi, , India
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Secunderabad, , India
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Surat, , India
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Aichi, , Japan
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Fukuoka, , Japan
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Gunma, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Ibaraki, , Japan
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Kanagawa, , Japan
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Kumamoto, , Japan
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Mie, , Japan
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Miyagi, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Nara, , Japan
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Ohita, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Saga, , Japan
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Saitama, , Japan
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Sapporo, , Japan
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Shizuoka, , Japan
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Tokyo, , Japan
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Tomakomai, , Japan
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Klaipedos, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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Batu Caves, , Malaysia
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Kuantan Pahang, , Malaysia
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Perak, , Malaysia
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Sarawak, , Malaysia
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Mexicali, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Querétaro, , Mexico
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San Luis Potosí City, , Mexico
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Tijuana, , Mexico
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Tlalpan, , Mexico
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Hamilton, , New Zealand
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Rotorua, , New Zealand
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Tauranga, , New Zealand
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Timaru, , New Zealand
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Bydgoszcz, , Poland
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Elblag, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Brasov, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Ploieşti, , Romania
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Barnaul, , Russia
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Kemerovo, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Stavropol, , Russia
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Bratislava, , Slovakia
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Piešťany, , Slovakia
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Benoni, , South Africa
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Bloemfontein, , South Africa
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Breyten, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Limpopo, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Stellenbosch, , South Africa
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Westville, , South Africa
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Busan, , South Korea
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Daegu, , South Korea
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Seoul, , South Korea
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Colombo, , Sri Lanka
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Galle, , Sri Lanka
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Kalubowila, , Sri Lanka
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Nugegoda, , Sri Lanka
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Keelong, , Taiwan
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Kuei Shan Hsiang, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Simferopol, , Ukraine
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.
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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H9B-MC-BCDO
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2011/07/001867
Identifier Type: REGISTRY
Identifier Source: secondary_id
12978
Identifier Type: -
Identifier Source: org_study_id
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