Arthritis, Rheumatoid

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

NCT00867516 | PHASE 2 | 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.

26 Sites

127 Participants

COMPLETED

18 Years to 80 Years

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SUBMIT

KW Musculoskeletal Research, Inc.

Kitchener,Ontario,Canada,N2M5N6

Rheumatology Research Associates

Ottawa,Ontario,Canada,KIHIA2

V. Tsitlanadze Scientific Practical Centre of Rheumatology

Tbilisi,Ontario,Georgia,0102

Medulla Chemotherapy and Immunotherapy Clinic

Tbilisi,Ontario,Georgia,0186

Chanre Rheumatology and Immunology Center and Research

Malleshwaram,Bangalore,India,560003

KLE Society Hospital and Medical Research Centre

Nehru Nagar,Belgaum,India,590010

Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics

Ramadaspeth,Nagpur,India,440010

St. John's Medical College Hospital

Bangalore,Nagpur,India,560034

Krishna Institute of Medical Sciences Ltd.

Secunderabad,Nagpur,India,500003

Miriada Center Private Clinic of Professor Sierakowski

Bialystok,Nagpur,Poland,15-297

Nonpublic Centre of Medical Care Reumed

Lublin,Nagpur,Poland,26-607

NOVAMED Medical Center of Poznan

Poznan,Nagpur,Poland,60-773

Provincional Rheumatological Complex named after Dr Jadwiga TitzKosko

Sopot,Nagpur,Poland,81-759

Szezecin Clinic of Rheumatology and Internal Diseases

Szczecin,Nagpur,Poland,71-252

Regional Clinical Hospital of War Veterans

Kemerovo,Nagpur,Russia,650099

Institute of Clinical and Experimental Lymphology

Novosibirsk,Nagpur,Russia,630117

Ryazan Regional Clinical Cardiologic Dispensary

Ryazan,Nagpur,Russia,390026

Saint Petersburg Medical Academy of Postgraduate Study

Saint Petersburg,Nagpur,Russia,191015

SaintPetersburg State Medical Academy named after I. I. Mechnikov

Saint Petersburg,Nagpur,Russia,195067

City Hospital #

Saint Petersburg,Nagpur,Russia,196247

Regional War Veterans' Hospital

Saratov,Nagpur,Russia,410002

Tomsk Regional Clinical Hospital

Tomsk,Nagpur,Russia,634063

Tula Regional Clinical Hospital

Tula,Nagpur,Russia,300053

Clinical Hospital of Emergency Care named after N.V. Solovyev

Yaroslavl,Nagpur,Russia,150003

Institute of Rheumatology

Belgrade,Nagpur,Serbia,11000

Institute for Rehabilitation and Treatment Niska Banja

Niška Banja,Nagpur,Serbia,18205

Study 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov