NCT00550355

Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	PD 0360324	3 doses of PD 0360324 (Dose level 1) administered over 12 weeks
DRUG	PD 0360324	3 doses of PD 0360324 (Dose level 2) administered over 12 weeks
DRUG	PD 0360324	3 doses of PD 0360324 (Dose level 3) administered over 12 weeks
DRUG	Placebo	3 doses of Placebo administered over 12 weeks

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-10-29
• Last updated: 2009-07-14

Locations

25 sites across 8 countries: United States, Argentina, Bulgaria, Czechia, Mexico, Poland, Slovakia, Spain