Study to Evaluate the Efficacy and Safety of Orally Administered Rob 803 When Added to Methotrexate
- Registration Number
- NCT00525213
- Lead Sponsor
- OxyPharma
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- Diagnosed with RA based on the ARA 1987 revised criteria at least 16 weeks prior to study enrolment, Day 0
- Have an ACR global functional status class of 1 to 3
- Have active disease, defined as the presence of 6 swollen joints and 6 tender joints in a 44 joint examination
- Have a CRP level at screening of ≥ 1.5 mg/dL
- Have been taking oral or parenteral methotrexate (15 mg weekly or above), have been using methotrexate for at least 16 weeks (up to Day 0 of study), and have been on a stable dose for at least 8 weeks, up to Day 0.
- Arthritis onset prior to 16 years old
- Any of the following infections:
- Known or acute infection that may affect CRP levels
- Active tuberculosis
- Known chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) including positive serology
- Ongoing systemic inflammatory condition which may interfere with the results of clinical or laboratory tests planned in the study (eg, systemic lupus erythematosus or any other systemic rheumatic disease other than RA)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Rob 803 - B Rob 803 - C Rob 803 - D Placebo -
- Primary Outcome Measures
Name Time Method 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. 12 weeks
- Secondary Outcome Measures
Name Time Method Evaluate the safety of Rob 803 administered orally once daily in combination with a stable dose of methotrexate in subjects with moderate or severe active RA 12 weeks
Trial Locations
- Locations (34)
Vectasearch Clinic Ltd St Mary's Hospital
🇬🇧Newport, United Kingdom
"Sf. Maria" Clinical Hospital
🇷🇴Bucharest, Romania
Rheumatology Unit North Tyneside District General Hospital
🇬🇧North Shields, United Kingdom
Rheumatology Department Cemotherapy and Immunotherapy Clinical
🇬🇪Tbilisi, Georgia
Rheumatology Clinic Hospital of Kaunas University of Medicine
🇱🇹Kaunas, Lithuania
D Saulites-Kandevicas gimenes arsta prakse
🇱🇻Liepaja, Aldaru iela 8,, Latvia
"Dr. I. Cantacuzino" Clinical Hospital
🇷🇴Bucharest, Romania
"Dr. Constantin Papilian"
🇷🇴Cluj-Napoca,, Romania
Reumatologiska kliniken Karolinska Sjukhuset
🇸🇪Stockholm, Sweden
Clinic of Cardiology and Rheumatology UMHAT "Dr. Georgi Stranski"
🇧🇬Pleven, Bulgaria
AZ Sint-Lucas Gent Reumatologie
🇧🇪Gent, Belgium
Reumainstituut Anne Frankplein 17
🇧🇪Hasselt, Belgium
Clinic of Rheumatology, UMHAT "Sveta Marina",
🇧🇬Varna, Bulgaria
Poznanski Osrodek Medyczny Nova Med
🇵🇱Poznan, Poland
Centrum Medyczne Osteomed
🇵🇱Warszawa, Poland
Musculo Skeletal dept Chapel Allerton Hospital
🇬🇧Leeds, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
UMHAT sveti georgi
🇧🇬Ploviv, Bulgaria
Center of Reumathology Vilnius University hospital Santariskiu Clinics
🇱🇹Vilnius, Lithuania
Emergency Clinical County Hospital
🇷🇴Cluj Napoca, Romania
Emergency County Hospital
🇷🇴Sibiu, Romania
Department of Rheumocardiology, Pulmonology and General Therapy
🇧🇬Sofia, Bulgaria
Department of Therapy and diagnostics Siauliai district hospital
🇱🇹Siauliai, Lithuania
Rehabilitation Clinical Hospital
🇷🇴Lasi, Romania
Institute of Rheumatology Belgrade
🇷🇸Belgrade, Serbia
Clinic of Rheumatology MHAT "Sveti Ivan Rilski"
🇧🇬Sofia, Bulgaria
Institute for Prevention, Treatment and Rehabilitation of Rheumatic and Cardiovascular Diseases
🇷🇸Niska Banja, Serbia
Centrum Miriada Prywatny Gabinet
🇵🇱Bialystok, Poland
Szpital Specjalistyczny Nr 1 Oddzial Reumatologii i Rehabilitacji
🇵🇱Bytom, Poland
Indywidualna Specjalistyczna Praktyka
🇵🇱Szczecin, Poland
CUB Hôpital Erasme Université Libre de Bruxelles Service de Rhumatologie
🇧🇪Bruxelles, Belgium
Academician V Tsitlanadze Scientific-Practical Centre of Rheumatolgoy
🇬🇪Tbilisi, Georgia
Salenieces arsta reimatologa prakse
🇱🇻Valmiera, Latvia
Prywatny Gabinet Lekarski
🇵🇱Wroclaw, Poland