Great Lakes Clinical Trials is proud to share the results of a Rheumatoid Arthritis clinical trial conducted at our research clinic under the direction of our board-certified Rheumatologist, Dr. Manish Jain.
“We are excited to have such a quality Rheumatology research team on staff led by Dr. Jain,” commented Steve Satek, President of Great Lakes Clinical Trials. “We are grateful for the commitment of volunteers who joined this clinical trial. Without their participation, we would not be able to bring new effective medications to market to treat this painful and debilitating disease.”
Great Lakes Clinical Trials is currently conducting multiple clinical trials in Rheumatoid Arthritis. For more information on these programs or to sign up, click HERE to be directed to our webpage dedicated to our Rheumatoid Arthritis program.
The following are key highlights of the press release announcing the results of this study. To view a full copy of the press release, click the button at the bottom of the page.
AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints
SELECT-MONOTHERAPY, the third study in the robust SELECT program, showed positive results, with both doses (15 mg and 30 mg once-daily) meeting the primary endpoints in patients with an inadequate response to methotrexate
Upadacitinib monotherapy resulted in low disease activity by week 14 in 45 percent of patients in the 15 mg group and 53 percent in the 30 mg group
A response of ACR20/50/70 was achieved by 68/42/23 percent of patients receiving 15 mg upadacitinib and 71/52/33 percent of patients receiving 30 mg of upadacitinib
The safety profile of upadacitinib was consistent with previously reported Phase 3 studies, with no new safety signals detected
Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis in the SELECT program and across multiple immune-mediated diseases
NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20 and low disease activity (LDA) versus continuing prior stable methotrexate therapy.1 Both doses also achieved all ranked and all key secondary endpoints. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
"The positive results from the SELECT-MONOTHERAPY study are encouraging, as they are the first evidence to support the potential of upadacitinib as a therapy without the need for background methotrexate," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These findings add to the growing body of data showing the potential for upadacitinib as a meaningful treatment option for patients suffering from rheumatoid arthritis. We look forward to sharing additional data from the upadacitinib Phase 3 rheumatoid arthritis program with the scientific community in 2018."