Clinical trial NCT01202760: A Rheumatoid Arthritis Study in Participants
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses
timeFrame: Up to 24 weeks
measure: Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N)
timeFrame: Up to 24 weeks
measure: Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP)
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline, up to 24 weeks
measure: Time to American College of Rheumatology 20% (ACR20) Response
timeFrame: Baseline through 24 weeks
measure: Probability of an ACR20 Response by 24 Weeks
timeFrame: Baseline through 24 weeks
measure: Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response
timeFrame: Up to 24 weeks
measure: Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts
timeFrame: Baseline, up to 24 weeks
measure: Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels
timeFrame: Baseline, up to 24 weeks
measure: Population Pharmacokinetics (PK)
timeFrame: Baseline through 24 weeks
measure: Percentage of Participants Developing Anti-LY2127399 Antibodies
timeFrame: Baseline through 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 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.
state: Alabama
city: Paradise Valley
country: United States
facility: 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.
state: Arizona
city: Peoria
country: United States
facility: 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.
state: Arizona
city: Phoenix
country: United States
facility: 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.
state: Arizona
city: Scottsdale
country: United States
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state: Arizona
city: Tucson
country: United States
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state: Arizona
city: Hot Springs
country: United States
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state: Arkansas
city: Little Rock
country: United States
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state: Arkansas
city: San Diego
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Tustin
country: United States
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state: California
city: Whittier
country: United States
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state: California
city: Wildomar
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Lewes
country: United States
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state: Delaware
city: Aventura
country: United States
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state: Florida
city: DeBary
country: United States
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state: Florida
city: Palm Harbor
country: United States
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state: Florida
city: Pinellas Park
country: United States
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state: Florida
city: Saint Petersburg
country: United States
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state: Florida
city: Tamarac
country: United States
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state: Florida
city: Venice
country: United States
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state: Florida
city: Zephyrhills
country: United States
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state: Florida
city: Decatur
country: United States
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state: Georgia
city: Gainesville
country: United States
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state: Georgia
city: Lawrenceville
country: United States
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state: Georgia
city: Marietta
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Eagle
country: United States
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state: Idaho
city: Morton Grove
country: United States
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state: Illinois
city: Rockford
country: United States
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state: Illinois
city: Indianapolis
country: United States
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state: Indiana
city: Wichita
country: United States
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state: Kansas
city: Cumberland
country: United States
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state: Maryland
city: Hyannis
country: United States
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state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Bingham Farms
country: United States
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state: Michigan
city: Saint Clair Shores
country: United States
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state: Michigan
city: Flowood
country: United States
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state: Mississippi
city: Jackson
country: United States
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state: Mississippi
city: Saint Louis
country: United States
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state: Missouri
city: Lincoln
country: United States
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state: Nebraska
city: Omaha
country: United States
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state: Nebraska
city: Las Vegas
country: United States
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state: Nevada
city: Albuquerque
country: United States
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state: New Mexico
city: Brooklyn
country: United States
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state: New York
city: Roslyn
country: United States
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state: New York
city: Syracuse
country: United States
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state: New York
city: Charlotte
country: United States
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state: North Carolina
city: Hickory
country: United States
facility: 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.
state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Cincinnati
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Bend
country: United States
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state: Oregon
city: Bethlehem
country: United States
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state: Pennsylvania
city: Limerick
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Pottstown
country: United States
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state: Pennsylvania
city: Columbia
country: United States
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state: South Carolina
city: Greenville
country: United States
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state: South Carolina
city: Greer
country: United States
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state: South Carolina
city: Myrtle Beach
country: United States
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state: South Carolina
city: North Charleston
country: United States
facility: 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.
state: South Carolina
city: Knoxville
country: United States
facility: 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.
state: Tennessee
city: Memphis
country: United States
facility: 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.
state: Tennessee
city: Nashville
country: United States
facility: 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.
state: Tennessee
city: Austin
country: United States
facility: 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.
state: Texas
city: Dallas
country: United States
facility: 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.
state: Texas
city: Lake Jackson
country: United States
facility: 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.
state: Texas
city: Lubbock
country: United States
facility: 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.
state: Texas
city: Mesquite
country: United States
facility: 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.
state: Texas
city: Nassau Bay
country: United States
facility: 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.
state: Texas
city: North Richland Hills
country: United States
facility: 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.
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Sugar Land
country: United States
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state: Texas
city: Spokane
country: United States
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state: Washington
city: Buenos Aires
country: Argentina
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city: Córdoba
country: Argentina
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city: Mar Del Plata
country: Argentina
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city: Rosario
country: Argentina
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city: San Juan
country: Argentina
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city: Tucuman
country: Argentina
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city: Kogarah
country: Australia
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state: New South Wales
city: Herston
country: Australia
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state: Queensland
city: Malvern East
country: Australia
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city: Burgas
country: Bulgaria
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city: Pleven
country: Bulgaria
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city: Plovdiv
country: Bulgaria
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city: Rousse
country: Bulgaria
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city: Sevlievo
country: Bulgaria
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city: Sofia
country: Bulgaria
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city: Varna
country: Bulgaria
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city: Bogota
country: Colombia
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city: Medellin
country: Colombia
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city: Opatija
country: Croatia
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city: Rijeka
country: Croatia
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city: Split
country: Croatia
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city: Budapest
country: Hungary
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city: Debrecen
country: Hungary
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city: Kiskunhalas
country: Hungary
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city: Nyiregyhaza
country: Hungary
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city: Satoraljaujhely
country: Hungary
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city: Szikszo
country: Hungary
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city: Veszprem
country: Hungary
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city: Ahmedabad
country: India
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city: Bangalore
country: India
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city: Chennai
country: India
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city: Hyderabaad
country: India
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city: Jaipur
country: India
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city: Mysore
country: India
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city: Nellore
country: India
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city: New Delhi
country: India
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city: Secunderabad
country: India
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city: Surat
country: India
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city: Aichi
country: Japan
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city: Fukuoka
country: Japan
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city: Gunma
country: Japan
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city: Hokkaido
country: Japan
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city: Hyogo
country: Japan
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city: Ibaragi
country: Japan
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city: Kanagawa
country: Japan
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city: Kumamoto
country: Japan
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city: Mie
country: Japan
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city: Miyagi
country: Japan
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city: Nagano
country: Japan
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city: Nagasaki
country: Japan
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city: Nara
country: Japan
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city: Ohita
country: Japan
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city: Okayama
country: Japan
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city: Osaka
country: Japan
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city: Saga
country: Japan
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city: Saitama
country: Japan
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city: Sapporo-Shi
country: Japan
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city: Shizuoka
country: Japan
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city: Tokyo
country: Japan
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city: Tomakomai
country: Japan
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city: Busan
country: Korea, Republic of
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city: Daegu
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Alytus
country: Lithuania
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city: Kaunas
country: Lithuania
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city: Klaipedos
country: Lithuania
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city: Siauliai
country: Lithuania
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city: Vilnius
country: Lithuania
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city: Batu Caves
country: Malaysia
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city: Kuantan Pahang
country: Malaysia
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city: Perak
country: Malaysia
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city: Sarawak
country: Malaysia
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city: Aguascalientes
country: Mexico
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city: Chihuahua
country: Mexico
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city: Guadalajara
country: Mexico
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city: Mexicali
country: Mexico
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Morelia
country: Mexico
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city: Queretaro
country: Mexico
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city: San Luis Potosi
country: Mexico
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city: Tijuana
country: Mexico
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city: Tlalpan
country: Mexico
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city: Hamilton
country: New Zealand
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city: Rotorua
country: New Zealand
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city: Tauranga
country: New Zealand
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city: Timaru
country: New Zealand
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city: Bydgoszcz
country: Poland
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city: Elblag
country: Poland
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city: Gdynia
country: Poland
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city: Krakow
country: Poland
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city: Lublin
country: Poland
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city: Torun
country: Poland
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city: Warsaw
country: Poland
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city: Brasov
country: Romania
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city: Cluj-Napoca
country: Romania
facility: 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.
city: Iasi
country: Romania
facility: 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.
city: Ploiesti
country: Romania
facility: 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.
city: Barnaul
country: Russian Federation
facility: 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.
city: Kemerovo
country: Russian Federation
facility: 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.
city: Kursk
country: Russian Federation
facility: 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.
city: Moscow
country: Russian Federation
facility: 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.
city: Nizhny Novgorod
country: Russian Federation
facility: 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.
city: Novosibirsk
country: Russian Federation
facility: 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.
city: Ryazan
country: Russian Federation
facility: 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.
city: Saint Petersburg
country: Russian Federation
facility: 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.
city: Stavropol
country: Russian Federation
facility: 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.
city: Bratislava
country: Slovakia
facility: 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.
city: Piestany
country: Slovakia
facility: 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.
city: Benoni
country: South Africa
facility: 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.
city: Bloemfontein
country: South Africa
facility: 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.
city: Breyten
country: South Africa
facility: 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.
city: Cape Town
country: South Africa
facility: 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.
city: Durban
country: South Africa
facility: 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.
city: Limpopo
country: South Africa
facility: 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.
city: Pretoria
country: South Africa
facility: 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.
city: Somerset West
country: South Africa
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city: Stellenbosch
country: South Africa
facility: 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.
city: Westville
country: South Africa
facility: 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.
city: Colombo
country: Sri Lanka
facility: 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.
city: Galle
country: Sri Lanka
facility: 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.
city: Kalubowila
country: Sri Lanka
facility: 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.
city: Nugegoda
country: Sri Lanka
facility: 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.
city: Keelong
country: Taiwan
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city: Kuei Shan Hsiang
country: Taiwan
facility: 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.
city: Taichung
country: Taiwan
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city: Taipei
country: Taiwan
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city: Dnipropetrovsk
country: Ukraine
facility: 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.
city: Donetsk
country: Ukraine
facility: 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.
city: Kharkiv
country: Ukraine
facility: 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.
city: Kiev
country: Ukraine
facility: 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.
city: Kyiv
country: Ukraine
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city: Odesa
country: Ukraine
facility: 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.
city: Poltava
country: Ukraine
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city: Simferopol
country: Ukraine
facility: 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.
city: Vinnytsya
country: Ukraine
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: