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

Arthritis, Rheumatoid Clinical Trial

— ALD518-003  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867516
• Other study ID #: ALD518-CLIN-003
• Status: Completed
• Phase: Phase 2
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2017
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Biological:
• ALD518
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
• Infusion without ALD518`
250 cc Normal saline IV over one hour Weeks 1 and 8.

Locations

Country	Name	City	State
Canada	K-W Musculoskeletal Research, Inc.	Kitchener	Ontario
Canada	Rheumatology Research Associates	Ottawa	Ontario
Georgia	Medulla Chemotherapy and Immunotherapy Clinic	Tbilisi
Georgia	V. Tsitlanadze Scientific Practical Centre of Rheumatology	Tbilisi
India	St. John's Medical College Hospital	Bangalore
India	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	Krishna Institute of Medical Sciences Ltd.	Secunderabad
Poland	Miriada Center Private Clinic of Professor Sierakowski	Bialystok
Poland	Nonpublic Centre of Medical Care Reumed	Lublin
Poland	NOVAMED - Medical Center of Poznan	Poznan
Poland	Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko	Sopot
Poland	Szezecin Clinic of Rheumatology and Internal Diseases	Szczecin
Russian Federation	Regional Clinical Hospital of War Veterans	Kemerovo
Russian Federation	Institute of Clinical and Experimental Lymphology	Novosibirsk
Russian Federation	Ryazan Regional Clinical Cardiologic Dispensary	Ryazan
Russian Federation	City Hospital #26	Saint Petersburg
Russian Federation	Saint Petersburg Medical Academy of Postgraduate Study	Saint-Petersburg
Russian Federation	Saint-Petersburg State Medical Academy named after I. I. Mechnikov	Saint-Petersburg
Russian Federation	Regional War Veterans' Hospital	Saratov
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Tula Regional Clinical Hospital	Tula
Russian Federation	Clinical Hospital of Emergency Care named after N.V. Solovyev	Yaroslavl
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute for Rehabilitation and Treatment Niska Banja	Niska Banja

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Canada,  Georgia,  India,  Poland,  Russian Federation,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of AEs and SAEs during the study		During entire length of study
Secondary	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