Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Genmab and GlaxoSmithKline are to begin a Phase III program with ofatumumab to treat rheumatoid arthritis. The program will commence with two studies which will be conducted outside the US, in two distinct patient populations. One study will be in patients who have had an inadequate response to methotrexate therapy, and the other in patients who had an inadequate response to TNF-alpha antagonist therapy.
Subscribe to our email newsletter
Each study will evaluate the efficacy of ofatumumab in reducing the clinical signs and symptoms in RA patients after a single course of ofatumumab and are comprised of a 24 week double-blind period followed by a 120 week open-label period during which re-treatment will be studied. The primary endpoint in each study is ACR20 at 24 weeks.
In the GEN410/OFA110635 clinical efficacy and safety study of ofatumumab, a total of approximately 250 patients who had an inadequate response to methotrexate therapy will be enrolled. While in the GEN411/OFA110634 clinical efficacy and safety study of ofatumumab, a total of approximately 250 patients who had an inadequate response to TNF-alpha antagonist therapy will be enrolled.
In the double-blind period of the two studies, patients will be randomized to receive two 700mg doses of ofatumumab or placebo two weeks apart in addition to background methotrexate. Rescue treatment with non-biologic disease modifying anti-rheumatic drugs (DMARDs) will be allowed from week 16 in the double-blind period. All patients who complete the double-blind period without receiving rescue treatment will continue into the open-label period of the study. Re-treatment will be studied starting at week 24. Disease status will be measured every 4 weeks during the double-blind period and every 8 weeks during the open-label period.
Ofatumumab is an investigational, fully human, next generation monoclonal antibody that targets a unique epitope of the CD20 receptor on the surface of B-cells.
Lisa Drakeman, CEO of Genmab, said: “From the data to date, we believe that ofatumumab has real potential. Now that Phase III studies are underway in multiple indications, we are moving closer to realizing this potential and bringing this important treatment to patients.”