A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
NCT ID: NCT02780388
Last Updated: 2024-12-27
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
PHASE1
57 participants
INTERVENTIONAL
2016-05-12
2018-08-09
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants will receive a single intravascular (IV) dose of placebo matched to VIB4920 (formerly MEDI4920) once every 2 weeks (Q2W) from Day 1 up to 12 weeks.
Placebo
Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
VIB4920 75 mg
Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
VIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
VIB4920 500 mg
Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
VIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
VIB4920 1000 mg
Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
VIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
VIB4920 1500 mg
Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
VIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
Interventions
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VIB4920
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
Placebo
Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* swollen and tender joints
Exclusion Criteria
* pregnant or breastfeeding
* positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
* active or untreated latent tuberculosis
18 Years
70 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Anniston, Alabama, United States
Research Site
DeBary, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Mesquite, Texas, United States
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Poznan, , Poland
Research Site
Warsaw, , Poland
Countries
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References
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Karnell JL, Albulescu M, Drabic S, Wang L, Moate R, Baca M, Oganesyan V, Gunsior M, Thisted T, Yan L, Li J, Xiong X, Eck SC, de Los Reyes M, Yusuf I, Streicher K, Muller-Ladner U, Howe D, Ettinger R, Herbst R, Drappa J. A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity. Sci Transl Med. 2019 Apr 24;11(489):eaar6584. doi: 10.1126/scitranslmed.aar6584.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-005318-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5100C00002
Identifier Type: -
Identifier Source: org_study_id