24.Dec.2012

OCT performed regulatory submission for post-marketing trial in Rheumatoid Arthritis

OCT is excited to announce that we have submitted all the required documentation to the regulatory authorities for this Phase IV post-marketing clinical trial in rheumatoid arthritis for our Sponsor. Everything is set in place for the start of this trial. It will be a randomized, multicenter, double-blind, and placebo-controlled study to confirm the efficacy and evaluate the pharmacodynamics, safety, and tolerability of the combination of the study drug along with the reference drug in patients who have rheumatoid arthritis.

OCT is excited to announce that we have submitted all the required documentation to the regulatory authorities for this Phase IV post-marketing clinical trial in rheumatoid arthritis for our Sponsor. Everything is set in place for the start of this trial. It will be a randomized, multicenter, double-blind, and placebo-controlled study to confirm the efficacy and evaluate the pharmacodynamics, safety, and tolerability of the combination of the study drug along with the reference drug in patients who have rheumatoid arthritis.

This clinical study will have a total duration time of 23 months. The enrollment which OCT is fully and solely responsible for is scheduled to take about 8 months to gather, a total of 120 patients. This study has an adaptive design, which is unique in the regard that when the clinical trial reaches the halfway point there will be an analysis of the therapy efficacy performed. Based on this interim analysis results, a decision will be made whether to termination, continue, or adjust the sample size in the study. This clinical trial will be exclusively conducted in Russia, where there will be 10 investigational sites spread out throughout the country in various regions. OCT is responsible for the full service operations for this clinical trial, in this case that is starting with the submission to the RA and ending with the closing of the sites and analyzing the data from the trial using our EDC system.

OCT has had previous experience in performing clinical studies in this therapeutic area of systemic inflammatory disorders. We are very much looking forward to getting this trial underway for our Sponsor, and hopefully bringing a new and effective medication on the market, for rheumatoid arthritis which affects millions of people worldwide. According to the WHO women are twice more susceptible to rheumatoid arthritis as are men at almost any age. The CDC Center for Disease Control claims that individuals over the age of 65 have a 50% chance of having rheumatoid arthritis and if not this arthritis likely another different form. It is estimated that by 2030 that the percentage will be 67% meaning as developed nations only get older it is important to develop a proper medication to treat this population.