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

CSL Behring127 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

127

Conditions

Arthritis, Rheumatoid

Interventions

ALD518BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

Incidence and severity of AEs and SAEs during the study

Time frame: During entire length of study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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K-W Musculoskeletal Research, Inc.

Kitchener, Ontario, Canada

Rheumatology Research Associates

Ottawa, Ontario, Canada

V. Tsitlanadze Scientific Practical Centre of Rheumatology

Tbilisi, Georgia

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi, Georgia

Chanre Rheumatology and Immunology Center and Research

Malleshwaram, Bangalore, India

KLE Society Hospital and Medical Research Centre

Nehru Nagar, Belgaum, India

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics

Ramadaspeth, Nagpur, India

St. John's Medical College Hospital

Bangalore, India

Krishna Institute of Medical Sciences Ltd.

Secunderabad, India

Miriada Center Private Clinic of Professor Sierakowski

Bialystok, Poland

...and 16 more locations