On November 12, 2019, a poster presentation of the TOP line results of CREDO 1 clinical study, the first study of a large-scale CREDO program consisting of four international phase 3 studies, was held at the Annual Congress of the American College of Rheumatology (ACR) in Atlanta, Georgia, USA. The purpose of this program is to evaluate the treatment efficacy and safety of olokizumab in patients with rheumatoid arthritis.
Mark Genovese, a professor of Stanford University, presented the results of CREDO 1 study. The primary endpoint - a statistically significant reduction in the severity of symptoms (ACR20 criterion) compared to a placebo group at week 12 of therapy was achieved. Secondary efficacy endpoints were also met. The safety profile of olokizumab was in line with expected for IL-6 inhibitor class drugs profile.
"The results of the CREDO 1 study demonstrated efficacy of olokizumab in patients with rheumatoid arthritis resistant to methotrexate. We all looking forward to analyze results of other recently completed CREDOs studies in patients who are resistant to biologics (inhibitors of tumor necrosis factors). This innovative monoclonal antibody can make a significant contribution to fight against such a severe disabling disease as rheumatoid arthritis in the nearest future“, said Alexey Repik the
About CREDO 1 Study.
428 patients were enrolled into the trial at 43 research sites of Russia, Belarus and Bulgaria. 381 patients were enrolled in Russia. The primary objective of this study is to evaluate the efficacy of olokizumab versus placebo in patients with moderately to severely active rheumatoid arthritis inadequately controlled by methotrexate therapy. Patients were randomized into 1 of 3 double- blind treatment arms: olokizumab 64 mg administred subcutaneously once every 2 weeks or once every 4 weeks, or placebo. The CREDO 1 study included a 24-week double-blind treatment period and a safety follow-up period from Week 24 to Week 44. After completion of this trial patients were eligible to enter CREDO 4 (an open long-term extension study evaluating tolerability and safety of olokizumab).
About CREDO Program
Clinical Rheumatoid Arthritis Development for olokizumab/CREDO is a clinical phase 3 trials program for olokizumab that consist of the following studies:
• CREDO 1 (NCT02760368) is a regional multicenter study evaluating olokizumab versus placebo efficacy and safety in RA patients from Russia / Belarus / Bulgaria with inadequate response to methotrexate.
• CREDO 2 (NCT02760407) is a global multicenter comparative study evaluating olokizumab versus adalimumab and placebo efficacy and safety in RA patients with inadequate response to methotrexate.
• CREDO 3 (NCT02760433) is a global study evaluating olokizumab versus placebo efficacy and safety in RA patients with inadequate response to TNF-α therapies.
CREDO 4 is a common open-label extension study for patients who have completed CREDO 1, CREDO 2, or CREDO 3.
About Rheumatoid Arthritis
Rheumatoid arthritis is widespread globally. According to a Russian epidemiological study RAiSeR, over 700,000 people suffer from rheumatoid arthritis in Russia. This is a systemic connective tissue disease that typically affects small joints as an erosive-destructive polyarthritis with a complex autoimmune pathogenesis, leading to early disability and a shortened life expectancy of patients. The basis for treating rheumatoid arthritis is an anti-inflammatory therapy, which includes the use of a wide range of drugs. In recent years, several innovative genetically engineered biological products have been developed to treat this disease. Olokizumab is one of these innovative drugs that blocks one of the important pro-inflammatory cytokine (IL-6).
RAiSeR - Фаломеева O.M., Насонов Е.Л., Andrianova I.A., Галушко Е.А., Goryachev D.V., Dubinina T.V., Zhornyak A.P., Krichevskaya O.A., Эрдес Ш.Ф., Folomeyeva O.M., Насонов Е.Л., Andrianova I.A., Галушко Е.А., Goryachev D.V., Dubinina T.V., Zhornyak A.P., Krichevskaya O.A., Эрдес Ш.Ф. РЕВМАТОИДНЫЙ АРТРИТ В РЕВМАТОЛОГИЧЕСКОЙПРАКТИКЕ РОССИИ: ТЯЖЕСТЬ ЗАБОЛЕВАНИЯ В РОССИЙСКОЙПОПУЛЯЦИИ БОЛЬНЫХ. ОДНОМОМЕНТНОЕ (ПОПЕРЕЧНОЕ)ЭПИДЕМИОЛОГИЧЕСКОЕ ИССЛЕДОВАНИЕ (RAISER). Научно-практическая ревматология. 2010;48(1):50-60. https://doi.org/10.14412/1995-4484-2010-1406