|
|
|
|
|
Sponsored by: |
OxyPharma |
Information provided by: | OxyPharma |
ClinicalTrials.gov Identifier: | NCT00525213 |
The primary objective of this study is to evaluate the efficacy (ACR20) of Rob 803 administered orally once daily for 12 weeks in combination with a stable dose of methotrexate in subjects with moderate or severe active RA.
Condition | Intervention | Phase |
Rheumatoid Arthritis |
Drug: Rob 803 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Rheumatoid Arthritis |
ChemIDplus related topics: | Methotrexate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomised, Double-Blind, International, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel-Group Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Stable Methotrexate |
Estimated Enrollment: | 224 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
A: Active Comparator | Drug: Rob 803 |
B: Active Comparator | Drug: Rob 803 |
C: Active Comparator | Drug: Rob 803 |
D: Placebo Comparator | Drug: Placebo |
Rheumatoid arthritis (RA) is a common, chronic, disabling systemic autoimmune disease in which inflammation of the joint lining (synovium) occurs when the body's tissues are attacked by the immune system. The joint inflammation begins in the synovium and slowly destroys the cartilage, narrowing the joint and eventually damaging the bone. A large amount of inflammatory mediators or rheumatoid factors are synthesised in the joint which accelerate proliferation and differentiation of immune cells further to amplify the autoimmune reaction. A widely accepted model has emerged in which the presence of inflammation in established RA is driven by interactions between T cells, macrophages, and fibroblasts in an abnormal microenvironment.
Rheumatoid arthritis has an annual incidence of approximately 0.2 per 1000 in males and 0.4 per 1000 in females. In general, higher rates have been reported in the USA than in European populations. The incidence of RA increases with age until the mid 70s. A prevalence of 0.5-1% is reported in diverse populations world-wide.
Treatments for RA focus on relieving pain, reducing inflammation, slowing or stopping joint damage, and improving patients' well being and ability to function. Current therapies include non-steroidal anti-inflammatory drugs (NSAIDs) which target the clinical features of the disease to alleviate the pain and swelling that accompany RA, disease-modifying anti-rheumatic drugs (DMARDs) which target the actual cause of the disease and biological agents which are genetically engineered to target and modify the autoimmune response. Non-steroidal anti-inflammatory drugs are effective in managing the symptoms of RA, but are limiting as they cannot suppress progression of the disease. First line treatment on confirmation of RA is the use of DMARDs, supported by pain relief medication.
Biologic agents (TNF antagonists, anti B-cell agents and anti-interleukins) have proven effective in RA symptoms management. TNF antagonists have become an important therapeutic option in the treatment of advanced RA.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulf OS Björklund, M.Sc. Pharm | + 46 8 7261700 ext 02 | Ulf.bjorklund@oxypharma.com |
Belgium | |||||
CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie | Not yet recruiting | ||||
Bruxelles, Belgium | |||||
Principal Investigator: Michel Malaise, Prof | |||||
Sub-Investigator: Clio Ribbens, Dr | |||||
Sub-Investigator: Béatrice André, Dr | |||||
Sub-Investigator: Marie-Joëlle Kaiser, Dr | |||||
Sub-Investigator: Anne-Marie Jeugmans, Dr | |||||
Sub-Investigator: Catherine Lust, Dr | |||||
Sub-Investigator: Etienne Deflandre, Dr | |||||
CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie | Not yet recruiting | ||||
Bruxelles, Belgium | |||||
Principal Investigator: Thierry Appelboom, Prof | |||||
Sub-Investigator: Valérie Gangji, Dr | |||||
Sub-Investigator: Laure Tant, Dr | |||||
Sub-Investigator: Bruno Gilard, Dr | |||||
Sub-Investigator: Joëlle Margaux, Dr | |||||
Reumainstituut Anne Frankplein 17 | Not yet recruiting | ||||
Hasselt, Belgium | |||||
Principal Investigator: Jan Lenaerts, Dr | |||||
Sub-Investigator: Paul van Wanghe, Dr | |||||
Sub-Investigator: Luk Corluy, Dr | |||||
Sub-Investigator: Christine Langenaken, Dr | |||||
AZ Sint-Lucas Gent Reumatologie | Not yet recruiting | ||||
Gent, Belgium | |||||
Principal Investigator: Christine Ackerman, Dr | |||||
Sub-Investigator: Hilde Luyten, Dr | |||||
Bulgaria | |||||
Clinic of Rheumatology, UMHAT "Sveta Marina", | Not yet recruiting | ||||
Varna, Bulgaria, 9010 | |||||
Principal Investigator: Dimitar Karastatev, Assoc. Prof | |||||
Sub-Investigator: Tanya Shivacheva, Dr | |||||
Sub-Investigator: Siviq Kutsarova, Dr | |||||
Sub-Investigator: Maria Petrova, Dr | |||||
Sub-Investigator: Snezhanka Goreva, Dr | |||||
Department of Rheumocardiology, Pulmonology and General Therapy | Not yet recruiting | ||||
Sofia, Bulgaria, 1874 | |||||
Principal Investigator: Daniela Yaneva, Dr | |||||
Sub-Investigator: Ivan Bichovski, Dr | |||||
Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski" | Not yet recruiting | ||||
Pleven, Bulgaria, 5800 | |||||
Principal Investigator: Kiril Yablanski, Dr | |||||
Sub-Investigator: Virzhiniq Yordanova, Dr | |||||
Clinic of Rheumatology MHAT "Sveti Ivan Rilski" | Not yet recruiting | ||||
Sofia, Bulgaria, 1431 | |||||
Principal Investigator: Iordan Sheytanov, Prof | |||||
Sub-Investigator: Zlatimir Kolarov, Prof | |||||
Sub-Investigator: Ivan Sheytanov, Dr | |||||
Latvia | |||||
Salenieces arsta reimatologa prakse | Not yet recruiting | ||||
Valmiera, Latvia, LV4201 | |||||
Principal Investigator: Sarmite Saleniece, Dr | |||||
Latvia, Aldaru iela 8, | |||||
D Saulites-Kandevicas gimenes arsta prakse | Not yet recruiting | ||||
Liepaja, Aldaru iela 8,, Latvia, LV 3401 | |||||
Principal Investigator: Daina Saulite-Kandevica, Dr | |||||
Sub-Investigator: Iveta Sime, Dr | |||||
Lithuania | |||||
Rheumatology Clinic Hospital of Kaunas University of Medicine | Not yet recruiting | ||||
Kaunas, Lithuania | |||||
Principal Investigator: Asta Baranauskaite, Ass. Prof | |||||
Sub-Investigator: Margarita Pileckyte, Ass.Prof | |||||
Center of Reumathology Vilnius University hospital Santariskiu Clinics | Not yet recruiting | ||||
Vilnius, Lithuania | |||||
Principal Investigator: Danute Povilenaite, Dr | |||||
Sub-Investigator: Irena Butrimienė, Ass. Prof | |||||
Sub-Investigator: Jelena Ranceva, Dr | |||||
Sub-Investigator: Algirdas Venalis, Prof | |||||
Department of Therapy and diagnostics Siauliai district hospital | Not yet recruiting | ||||
Siauliai, Lithuania | |||||
Principal Investigator: Gailute Kirdaite, Ass. Prof | |||||
Sub-Investigator: Jolanta Jankauskiene, Dr | |||||
Sub-Investigator: Vida Basijokiene, Dr | |||||
Sub-Investigator: Rasa Kausiene, Dr | |||||
Romania | |||||
"Sf. Maria" Clinical Hospital | Not yet recruiting | ||||
Bucharest, Romania, 011172 | |||||
Principal Investigator: Andra Balanescu, Ass.Prof.Dr. | |||||
Sub-Investigator: Violeta Bojinca, Dr | |||||
Sub-Investigator: Daniela Opris, Dr | |||||
Sub-Investigator: Narcis Copca, Dr | |||||
"Dr. I. Cantacuzino" Clinical Hospital | Not yet recruiting | ||||
Bucharest, Romania, 020475 | |||||
Principal Investigator: Gabriela Udrea, Dr | |||||
Sub-Investigator: Mariana Sasu, Dr | |||||
Sub-Investigator: Claudia Ciofu, Dr | |||||
Sub-Investigator: Coziana Ciurtin, Dr | |||||
Rehabilitation Clinical Hospital | Not yet recruiting | ||||
Lasi, Romania, 700662 | |||||
Principal Investigator: Rodica Chirieac, Prof. Dr. | |||||
Sub-Investigator: Luana Macovei, Dr | |||||
Sub-Investigator: Codrina Ancuta, Dr | |||||
Emergency Clinical County Hospital | Not yet recruiting | ||||
Cluj Napoca, Romania, 400006 | |||||
Principal Investigator: Horatiu Bolosiu, Prof. Dr. | |||||
Serbia and Montenegro | |||||
Institute of Rheumatology Belgrade | Not yet recruiting | ||||
Belgrade, Serbia and Montenegro | |||||
Principal Investigator: Goran Radunovic, Dr | |||||
Sub-Investigator: Danijel Marcetic, Dr | |||||
Institute of Rheumatology Belgrade | Not yet recruiting | ||||
Belgrade, Serbia and Montenegro | |||||
Principal Investigator: Nemanja Damjanov, Prof. Dr | |||||
Sub-Investigator: Predrag Ostojic, Dr | |||||
Sub-Investigator: Olivera Vranesevic, Dr | |||||
Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases | Not yet recruiting | ||||
Niska Banja, Serbia and Montenegro | |||||
Principal Investigator: Aleksandar Dimic, Prof. Dr | |||||
Sub-Investigator: Aleksandra Stankovic, Prof. Dr | |||||
Sub-Investigator: Zorica Markovic, Prof. Dr | |||||
Sweden | |||||
Reumatologiska kliniken Karolinska Sjukhuset | Not yet recruiting | ||||
Stockholm, Sweden | |||||
Principal Investigator: Lars Klareskog, Prof | |||||
Sub-Investigator: Ronald van Vollenhoven, Dr | |||||
United Kingdom | |||||
Musculo Skeletal dept Chapel Allerton Hospital | Not yet recruiting | ||||
Leeds, United Kingdom | |||||
Principal Investigator: Paul Emery, Prof | |||||
Vectasearch Clinic Ltd St Mary's Hospital | Not yet recruiting | ||||
Newport, United Kingdom | |||||
Principal Investigator: Arun Baksi, Dr | |||||
Sub-Investigator: Mark Pugh, Dr | |||||
Rheumatology Unit North Tyneside District General Hospital | Not yet recruiting | ||||
North Shields, United Kingdom | |||||
Principal Investigator: David Walker, Dr | |||||
Norfolk and Norwich University Hospital | Not yet recruiting | ||||
Norwich, United Kingdom | |||||
Principal Investigator: Karl Gaffney, Dr |
OxyPharma |
Principal Investigator: | Lars Klareskog, Professor | Karolinska Hospital, Stockholm Sweden |
Study ID Numbers: | 2006-004834-33 |
First Received: | September 4, 2007 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00525213 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: Bulgarian Drug Agency; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Romania: National Medicines Agency; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
|
|
|
|