NCT00867516

Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis

A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.

Detailed description

This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate. Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups: Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo In all treatment groups patients will continue to take a stable dose of methotrexate. There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
BIOLOGICAL	ALD518	Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
BIOLOGICAL	Infusion without ALD518'	250 cc Normal saline IV over one hour Weeks 1 and 8.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2009-03-23
• Last updated: 2020-07-09

Locations

26 sites across 6 countries: Canada, Georgia, India, Poland, Russia, Serbia