Arthritis, Rheumatoid Clinical Trial
— ALD518-003Official 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
Verified date | September 2017 |
Source | CSL Behring |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
CSL Behring |
Canada, Georgia, India, Poland, Russian Federation, Serbia,
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 |
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