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NCT Number: NCT00867516

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

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

K-W Musculoskeletal Research, Inc., Kitchener, Ontario, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALD518

Biological

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

Infusion without ALD518'

Biological

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

Primary outcomes

  1. Incidence and severity of AEs and SAEs during the study

    Time frame: During entire length of study

Secondary outcomes

  1. 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

    Time frame: 12 weeks after Dose 1

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Acronym: ALD518-003

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 23, 2009
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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