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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Biological: ALD518
* Biological: Infusion without ALD518'


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Active Rheumatoid Arthritis for at least 16 weeks duration Have a C-reactive protein (CRP) of ≥ 10mg/L Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months Exclusion Criteria: Arthritis onset prior to 16 years old Received any biologic therapy in the previous 12 months A history of or currently have active tuberculosis Any clinically significant concurrent medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ALD518 80 mg | Biological: ALD518<br>* Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8<br>|
| Experimental: 2<br>ALD518 160 mg | Biological: ALD518<br>* Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8<br>|
| Experimental: 3<br>ALD518 320 mg | Biological: ALD518<br>* Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8<br>|
| Placebo Comparator: 4<br>No ALD518 | Biological: Infusion without ALD518'<br>* 250 cc Normal saline IV over one hour Weeks 1 and 8.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs and SAEs during the study |  | During entire length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12 |  | 12 weeks after Dose 1 |