Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02780388 |
Date of registration:
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03/05/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
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Scientific title:
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A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis |
Date of first enrolment:
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May 12, 2016 |
Target sample size:
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57 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02780388 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Poland
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult-onset rheumatoid arthritis
- swollen and tender joints
Exclusion Criteria:
- venous thromboembolism or arterial thrombosis
- pregnant or breastfeeding
- positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
- active or untreated latent tuberculosis
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Adult Onset Rheumatoid Arthritis
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Intervention(s)
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Other: Placebo
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Drug: VIB4920
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Primary Outcome(s)
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
[Time Frame: Day 1 through Day 169]
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Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
[Time Frame: Day 1 through Day 169]
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Secondary Outcome(s)
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Terminal Elimination Half-life (t½) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Accumulation Ratio (AR) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Systemic Clearance (CL) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920
[Time Frame: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Time to Maximum Plasma Concentration (Tmax) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Volume of Distribution at Steady State (Vss) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Dose Normalized AUCtau of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Maximum Observed Plasma Concentration (Cmax) of VIB4920
[Time Frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169]
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Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
[Time Frame: Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169]
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Secondary ID(s)
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2015-005318-30
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D5100C00002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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