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.
No locations available
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 |