Arthritis, Rheumatoid Clinical Trial
Official title:
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
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.
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).
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