NCT02047604

(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

A Randomized, Double-blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients With Active Rheumatoid Arthritis With Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	SAN-300 0.5 mg/kg QW
DRUG	SAN-300 1.0 mg/kg QW
DRUG	SAN-300 2.0 mg/kg QOW
DRUG	SAN-300 4.0 mg/kg QOW
DRUG	SAN-300 4.0 mg/kg QW
DRUG	Placebo

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-02-23
• Completion: 2017-03-23
• First posted: 2014-01-28
• Last updated: 2021-06-21
• Results posted: 2021-06-21

Locations

12 sites across 1 country: United States