An Open Label Extension Study in Participants With Rheumatoid Arthritis
NCT ID: NCT00837811
Last Updated: 2018-04-25
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
182 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-02-28
Study Completion Date
2012-01-31
Brief Summary
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To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
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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
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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LY2127399
Group Type
EXPERIMENTAL
LY2127399
Intervention Type
BIOLOGICAL
60 milligrams \[(mg) with potential for dose escalation to 120 mg\] subcutaneously every 4 weeks for 48 weeks
Interventions
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LY2127399
60 milligrams \[(mg) with potential for dose escalation to 120 mg\] subcutaneously every 4 weeks for 48 weeks
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
* Have given written informed consent
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
* Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
* Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Exclusion Criteria
* Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, \[including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment\] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
* Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
* Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
* Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
* Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
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
Site Status
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Huntsville, Alabama, United States
Site Status
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Mesa, Arizona, United States
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Palm Desert, California, United States
Site Status
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Riverside, California, United States
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Santa Maria, California, United States
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Upland, California, United States
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Jupiter, Florida, United States
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Vero Beach, Florida, United States
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Zephyrhills, Florida, United States
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Baltimore, Maryland, United States
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St Louis, Missouri, United States
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Hickory, North Carolina, United States
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Middleburg Heights, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Orangeburg, South Carolina, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Mesquite, Texas, United States
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Elizabeth Vale, South Australia, Australia
Site Status
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Vienna, , Austria
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Liège, , Belgium
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Campinas, , Brazil
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Curitiba, , Brazil
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Goiânia, , Brazil
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Porto Alegre, , Brazil
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Setor Oeste/Goiania, , Brazil
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Winnipeg, Manitoba, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Santiago, , Chile
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Valdivia, , Chile
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Viña del Mar, , Chile
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Hildesheim, , Germany
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Leipzig, , Germany
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Budapest, , Hungary
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Esztergom, , Hungary
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Kistarcsa, , Hungary
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Szolnok, , Hungary
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Lucknow, , India
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Pune, , India
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Secunderabad, , India
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Chihuahua City, , Mexico
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Tampico, , Mexico
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Bialystok, , Poland
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Chełm Śląski, , Poland
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Elblag, , Poland
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Krakow, , Poland
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Lubin, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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San Juan, , Puerto Rico
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Brasov, , Romania
Site Status
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Târgu Mureş, , Romania
Site Status
Countries
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United States
Australia
Austria
Belgium
Brazil
Canada
Chile
Germany
Hungary
India
Mexico
Poland
Puerto Rico
Romania
References
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Greenwald M, Szczepanski L, Kennedy A, Veenhuizen M, Komocsar WJ, Polasek E, Guerrettaz K, Berclaz PY, Lee C. A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell-activating factor monoclonal antibody, for rheumatoid arthritis. Arthritis Res Ther. 2014 Aug 29;16(4):415. doi: 10.1186/s13075-014-0415-2.
Reference Type
DERIVED
Other Identifiers
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H9B-MC-BCDI
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2009/091/000765
Identifier Type: REGISTRY
Identifier Source: secondary_id
11768
Identifier Type: -
Identifier Source: org_study_id
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