Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- 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
- 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
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
🇮🇳Ramadaspeth, Nagpur, India
Nonpublic Centre of Medical Care Reumed
🇵🇱Lublin, Poland
Rheumatology Research Associates
🇨🇦Ottawa, Ontario, Canada
Chanre Rheumatology and Immunology Center and Research
🇮🇳Malleshwaram, Bangalore, India
Szezecin Clinic of Rheumatology and Internal Diseases
🇵🇱Szczecin, Poland
V. Tsitlanadze Scientific Practical Centre of Rheumatology
🇬🇪Tbilisi, Georgia
Medulla Chemotherapy and Immunotherapy Clinic
🇬🇪Tbilisi, Georgia
Ryazan Regional Clinical Cardiologic Dispensary
🇷🇺Ryazan, Russian Federation
St. John's Medical College Hospital
🇮🇳Bangalore, India
Krishna Institute of Medical Sciences Ltd.
🇮🇳Secunderabad, India
Regional Clinical Hospital of War Veterans
🇷🇺Kemerovo, Russian Federation
City Hospital #26
🇷🇺Saint Petersburg, Russian Federation
Tula Regional Clinical Hospital
🇷🇺Tula, Russian Federation
KLE Society Hospital and Medical Research Centre
🇮🇳Nehru Nagar, Belgaum, India
Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
🇵🇱Sopot, Poland
Tomsk Regional Clinical Hospital
🇷🇺Tomsk, Russian Federation
Institute for Rehabilitation and Treatment Niska Banja
🇷🇸Niska Banja, Serbia
Clinical Hospital of Emergency Care named after N.V. Solovyev
🇷🇺Yaroslavl, Russian Federation
Miriada Center Private Clinic of Professor Sierakowski
🇵🇱Bialystok, Poland
NOVAMED - Medical Center of Poznan
🇵🇱Poznan, Poland
Institute of Clinical and Experimental Lymphology
🇷🇺Novosibirsk, Russian Federation
Saint-Petersburg State Medical Academy named after I. I. Mechnikov
🇷🇺Saint-Petersburg, Russian Federation
Regional War Veterans' Hospital
🇷🇺Saratov, Russian Federation
Institute of Rheumatology
🇷🇸Belgrade, Serbia
Saint Petersburg Medical Academy of Postgraduate Study
🇷🇺Saint-Petersburg, Russian Federation