A Rheumatoid Arthritis Study in Participants

NCT ID: NCT01202760

Last Updated: 2018-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-07-31

Brief Summary

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The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.

This study is comprised of 2 periods:

Period 1 - 24-week blinded treatment

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

Detailed Description

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In consideration of disease severity, all participants were assessed for non-response at Week 16. A total of 66 joints were examined for swelling, and a total of 66 joint were examined for tenderness. For participants who had at least 5 swollen and 5 tender joints at baseline, Week 16 non-responders (NRs) were defined as participants with \<20% improvement from baseline in both tender joint counts and swollen joint counts. For participants who did not have at least 5 swollen and 5 tender joints at baseline, Week 16 NRs were defined as participants who had at least 2 additional tender and 2 additional swollen joints from baseline. All Week 16 NRs and all participants who discontinued study treatment at any time, for any reason, were defined as NRs starting at that timepoint and going forward for all American College of Rheumatology (ACR) imputed analyses, including the Week 24 endpoint.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

Placebo

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

LY2127399

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

LY2127399

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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LY2127399

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Tabalumab

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
* 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

* Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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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Whittier, California, United States

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Wildomar, California, 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

Site Status

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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

Site Status

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Vinnytsia, , Ukraine

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Countries

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United States Argentina Australia Bulgaria Colombia Croatia Hungary India Japan Lithuania Malaysia Mexico New Zealand Poland Romania Russia Slovakia South Africa South Korea Sri Lanka Taiwan Ukraine

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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