Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
456 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2014-01-31
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 in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.
This study is comprised of 2 periods:
Period 1: 24-week blinded treatment
Period 2: 48-week post-treatment follow-up
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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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 milligrams (mg) LY2127399
Given every 4 weeks (Q4W) for 24 weeks. Participants receive a 240-mg loading dose when initiating treatment.
During the Treatment Period, for blinding purposes, participants will alternate injections of LY2127399 and injections of placebo every 2 weeks (Q2W).
At Week 16, responders will receive 1 injection of 120 mg of LY2127399 and 1 injection of placebo, followed by 120 mg of LY2127399 Q4W for the rest of the 24-week treatment period.
At Week 16, non-responders (NR) will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Placebo Q4W
Intervention Type
DRUG
Administered SC
90 mg LY2127399
Given Q2W for 24 weeks. Participants receive a 180-mg loading dose when initiating treatment.
At Week 16, both responders and NR will receive 1 injection of 90 mg of LY2127399 and 1 injection of placebo, followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Placebo
Given Q2W for 24 weeks. Participants receive 2 injections of placebo when initiating treatment.
At Week 16, responders will receive 2 injections of placebo, followed by 1 injection of placebo Q2W for the rest of the 24-week treatment period.
At Week 16, NR will receive a 180-mg loading dose of LY2127399 (2 injections of 90 mg), followed by 90 mg of LY2127399 Q2W for the rest of the 24-week treatment period.
Group Type
PLACEBO_COMPARATOR
LY2127399
Intervention Type
DRUG
Administered Subcutaneously (SC)
Placebo Q2W
Intervention Type
DRUG
Administered SC
Interventions
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LY2127399
Administered Subcutaneously (SC)
Intervention Type
DRUG
Placebo Q4W
Administered SC
Intervention Type
DRUG
Placebo Q2W
Administered SC
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RA of more than 6 months and less than 15 years
* At least 8 tender and swollen joints
* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
* Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
* Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
* At least 8 tender and swollen joints
* An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
* Positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody
* Previously treated with biologic TNF-α inhibitor therapy (infliximab, certolizumab, golimumab, etanercept, adalimumab) and stopped treatment due to insufficient efficacy or intolerance
* Regular use of at least 1 conventional disease-modifying anti-rheumatic drug (DMARD), with a stable dose for at least 8 weeks prior to study start
* Woman must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria
* Use of unstable doses of non-steroidal anti-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/day (mg/day) of oral steroids in the last 6 weeks
* 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 ago, 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 received 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
* Steroid injection or intravenous (IV) infusion in the last 6 weeks
* Use of more than 10 milligrams/day (mg/day) of oral steroids in the last 6 weeks
* 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 ago, 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 received 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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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Escondido, California, United States
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Fresno, California, United States
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Hemet, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Upland, 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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Denver, Colorado, United States
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Lewes, Delaware, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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DeBary, Florida, United States
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Miami, Florida, United States
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New Port Richey, 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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Tamarac, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Dunwoody, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Stockbridge, Georgia, United States
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Eagle, Idaho, United States
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Idaho Falls, Idaho, United States
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Peoria, Illinois, United States
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Rock Island, Illinois, United States
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Brownsburg, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Bowling Green, Kentucky, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Monroe, Louisiana, United States
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Wheaton, Maryland, United States
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Haverhill, Massachusetts, United States
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Worcester, Massachusetts, United States
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Saint Clair Shores, Michigan, United States
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Edina, Minnesota, United States
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Flowood, Mississippi, United States
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Jackson, Mississippi, United States
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Cape Girardeau, Missouri, United States
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Florissant, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Berkeley Heights, New Jersey, United States
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Clifton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Sanford, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Limerick, Pennsylvania, United States
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Wexford, 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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Taylors, 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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Houston, Texas, United States
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Lubbock, Texas, United States
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Mesquite, 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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Burlington, Vermont, United States
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Chesapeake, Virginia, United States
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Danville, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Wenatchee, Washington, United States
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Clarksburg, West Virginia, United States
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Milwaukee, Wisconsin, United States
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Racine, Wisconsin, United States
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Buenos Aires, , Argentina
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Córdoba, , Argentina
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Luján, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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San Isidro, , 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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Campinas, , Brazil
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Goiânia, , Brazil
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Juiz de Fora, , Brazil
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São Paulo, , Brazil
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Bogotá, , Colombia
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Medellín, , Colombia
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Montpellier, , France
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Nice, , France
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Orléans, , France
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Paris, , France
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Saint-Etienne, , France
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Strasbourg, , France
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Toulouse, , France
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Bad Doberan, , Germany
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Bad Nauheim, , Germany
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Baden-Baden, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Göttingen, , Germany
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Munich, , Germany
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Haidari/Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Arenzano, , Italy
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Fukuoka, , Japan
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Gunma, , Japan
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Hyōgo, , Japan
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Kanagawa, , Japan
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Miyazaki, , Japan
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Nagasaki, , Japan
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Okayama, , Japan
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Tokyo, , Japan
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Perak, , Malaysia
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Putrajaya, , Malaysia
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Sarawak, , Malaysia
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Chihuahua City, , Mexico
Site Status
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Col Centro, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Querétaro, , Mexico
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San Luis Potosí City, , Mexico
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Tlalpan, , Mexico
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Hamilton, , New Zealand
Site Status
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Rotorua, , New Zealand
Site Status
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Tauranga, , New Zealand
Site Status
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Timaru, , New Zealand
Site Status
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Bydgoszcz, , Poland
Site Status
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Elblag, , Poland
Site Status
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Lublin, , Poland
Site Status
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Płock, , Poland
Site Status
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Torun, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Kazan', , Russia
Site Status
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Khanty-Mansiysk, , Russia
Site Status
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Kursk, , Russia
Site Status
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Moscow, , Russia
Site Status
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Nizhny Novgorod, , Russia
Site Status
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Petrozavodsk, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Stavropol, , Russia
Site Status
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Voronezh, , Russia
Site Status
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Benoni, , South Africa
Site Status
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Bloemfontein, , South Africa
Site Status
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Limpopo, , South Africa
Site Status
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Incheon, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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A Coruña, , Spain
Site Status
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Barcelona, , Spain
Site Status
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Bilboa, , Spain
Site Status
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Madrid, , Spain
Site Status
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Manises, , Spain
Site Status
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Santiago de Compostela, , Spain
Site Status
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Keelung, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
Countries
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United States
Argentina
Australia
Brazil
Colombia
France
Germany
Greece
Italy
Japan
Malaysia
Mexico
New Zealand
Poland
Russia
South Africa
South Korea
Spain
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
Schiff M, Combe B, Dorner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.
Reference Type
DERIVED
Other Identifiers
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H9B-MC-BCDV
Identifier Type: OTHER
Identifier Source: secondary_id
13732
Identifier Type: -
Identifier Source: org_study_id
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