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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867516

Acronym

ALD518-003

Enrollment

127

Registered

2009-03-23

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief 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).

Interventions

BIOLOGICALALD518

Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8

BIOLOGICALInfusion without ALD518'

250 cc Normal saline IV over one hour Weeks 1 and 8.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence and severity of AEs and SAEs during the study	During entire length of study

Secondary

Measure	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

Countries

Canada, Georgia, India, Poland, Russia, Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026