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

Phase 2

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Biological: Infusion without ALD518'; Biological: ALD518

• Registration Number: NCT00867516
• Lead Sponsor: CSL Behring

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).

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Status Verified: 2017-09
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Infusion without ALD518'	No ALD518
2	ALD518	ALD518 160 mg
3	ALD518	ALD518 320 mg
1	ALD518	ALD518 80 mg

Primary Outcome Measures

Name	Time	Method
Incidence and severity of AEs and SAEs during the study	During entire length of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (26)

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

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