Study identifier:AMP-110-02
ClinicalTrials.gov identifier:NCT02277574
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Multi-Dose, Placebo-Controlled, Study of the Safety, Tolerability, Pharmacokinetics and Clinical Activity of AMP-110 in Subjects with Rheumatoid Arthritis
Rheumatoid Arthritis
Phase 1
No
-
All
29
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2016 by MedImmune, LLC
MedImmune, LLC
Daiichi Sankyo Co., Ltd.
This is a Phase 1b, randomized, multi-dose, placebo-controlled, dose-escalation, multi-center study of AMP-110 in adult subjects with rheumatoid arthritis.
Location
Location
Palm Harbor, Florida, United States, 34684
Location
Duncansville, PA, United States, 16635
Location
Dallas, TX, United States, 75231
Location
Frederick, MD, United States, 21702
Location
Anniston, AL, United States, 36207
Location
Lincoln, NE, United States, 68516
Location
Orlando, FL, United States, 32804
Arms | Assigned Interventions |
---|---|
Experimental: Crossover Group 1 Subjects assigned to this arm will receive 1 of 3 escalating doses of AMP-110 once a week for 4 weeks followed by 4 weekly doses of placebo | Biological/Vaccine: AMP-110 2, 5, or 10 mg/kg |
Experimental: Crossover Group 2 Subjects assigned to this arm will receive 4 weekly doses of placebo followed by 1 of 3 escalating doses of AMP-110 once a week for 4 week | Other: Placebo Placebo |
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