A new rheumatoid arthritis drug 5G1.1 will soon be entering a Phase IIb clinical trial designed to assess the safety and efficacy of the drug and to determine the most effective dose regimen.
This double-blind, randomized, placebo-controlled Phase IIb trial is expected to enroll 300 patients with mild to moderate rheumatoid arthritis and who are undergoing treatment with moderate doses of methotrexate or leflunomide.
“The commencement of this first 5G1.1 Phase IIb trial is an important step in the development of this promising drug candidate,” stated Leonard Bell, M.D., President and Chief Executive Officer of the drug’s manufacturer Alexion. “We seek to confirm the promising clinical data obtained in our earlier 5G1.1 rheumatoid arthritis study in this larger patient study. Importantly, we also seek to build on the durability of response observed in the previous study, which evaluated patients after three months of treatment.”
The trial will consist of three different treatment options. Patients will be treated with placebo; 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks and then once every month, or 5G1.1 at 8 mg/kg intravenous injection once per week for four weeks, and then once every two weeks.
The patients will be evaluated after six months for safety and efficacy. The primary efficacy endpoint will be the ACR20 score. The ACR20 score indicates that a patient had a 20% improvement in tender and swollen joint count plus 20% improvement in at least 3 of 5 of the following criteria: patient pain assessment, physician global assessment, patient global assessment, patient self-assessed disability and acute phase reactant.
As presented at the American College of Rheumatology scientific meetings in November 2001, in an earlier Phase II trial with 209 patients, 5G1.1 administration appeared to be safe and well tolerated.
The results after the three months of treatment showed that the Induction/monthly group met the primary endpoint of the trial, improvement in ACR20 score after three months of treatment, while the Induction/biweekly and Biweekly groups did not statistically meet the endpoint.
The kinds of adverse events found were comparable to placebo, and the most common adverse events were nausea and diarrhea.