Clinical trial NCT00867516: Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2009-03-23
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence and severity of AEs and SAEs during the study
timeFrame: During entire length of study
Secondary outcomes:
measure: 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
timeFrame: 12 weeks after Dose 1
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: K-W Musculoskeletal Research, Inc.
state: Ontario
city: Ottawa
country: Canada
facility: Rheumatology Research Associates
state: Ontario
city: Tbilisi
country: Georgia
facility: V. Tsitlanadze Scientific Practical Centre of Rheumatology
city: Tbilisi
country: Georgia
facility: Medulla Chemotherapy and Immunotherapy Clinic
city: Malleshwaram
country: India
facility: Chanre Rheumatology and Immunology Center and Research
state: Bangalore
city: Nehru Nagar
country: India
facility: KLE Society Hospital and Medical Research Centre
state: Belgaum
city: Ramadaspeth
country: India
facility: Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
state: Nagpur
city: Bangalore
country: India
facility: St. John's Medical College Hospital
city: Secunderabad
country: India
facility: Krishna Institute of Medical Sciences Ltd.
city: Bialystok
country: Poland
facility: Miriada Center Private Clinic of Professor Sierakowski
city: Lublin
country: Poland
facility: Nonpublic Centre of Medical Care Reumed
city: Poznan
country: Poland
facility: NOVAMED - Medical Center of Poznan
city: Sopot
country: Poland
facility: Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
city: Szczecin
country: Poland
facility: Szezecin Clinic of Rheumatology and Internal Diseases
city: Kemerovo
country: Russian Federation
facility: Regional Clinical Hospital of War Veterans
city: Novosibirsk
country: Russian Federation
facility: Institute of Clinical and Experimental Lymphology
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Cardiologic Dispensary
city: Saint Petersburg
country: Russian Federation
facility: City Hospital #26
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg Medical Academy of Postgraduate Study
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Medical Academy named after I. I. Mechnikov
city: Saratov
country: Russian Federation
facility: Regional War Veterans' Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital of Emergency Care named after N.V. Solovyev
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Niska Banja
country: Serbia
facility: Institute for Rehabilitation and Treatment Niska Banja
Study officials:
affiliation: Alder BioPharmaceuticals
name: Jeffrey Smith, MD, FRCP
role: STUDY_DIRECTOR
References: