Stay up to date on the latest arthritis drugs being developed by pharmaceutical companies and/or reviewed by the Food and Drug Administration (FDA).
June 2007
Preliminary Results for CellCept Phase III Study
Posted 6/28/2007
Preliminary results have been announced for a Phase III clinical trial comparing oral mycophenolate mofetil (CellCept) with intravenous cyclophosphamide for patients with lupus nephritis. Although response rates were similar in both arms, the trial did not meet its primary objective of demonstrating that mycophenolate mofetil was superior to cyclophosphamide in inducing treatment response.
Phase III Results of Nasal Morphine
Posted 6/20/2007
In its Phase III clinical trial, intranasal morphine (Rylomine) achieved better Sum of the Pain Intensity Difference (SPID) scores in the time period of zero to 24 hours after surgery. In this first of two Phase III studies, patients with moderate-to-severe pain after elective orthopedic surgery were given intranasal morphine or intravenous morphine as needed. Patients in each of the active treatment groups had significantly better SPID scores over 24 hours than the corresponding placebo groups.
Tocilizumab Results Announced
Posted 6/18/2007
The first rheumatoid arthritis (RA) multinational Phase III study of tocilizumab (Actemra) outside Japan announced results. The trial enrolled 623 patients with moderate-to-severe RA. In the 24-week study, 44 percent of patients in the tocilizumab group experienced 50 percent improvement in disease symptoms compared with 11 percent in the control group. In addition, 22 percent of the tocilizumab patients achieved 70 percent improvement compared with two percent in the control. Twenty-eight percent of patients achieved the ultimate goal of remission in the tocilizumab group versus only one percent of patients in the control group.
tgAAC94 Shows Promising Results
Posted 6/18/2007
The dose-escalation arm of the ongoing Phase I/II clinical study of tgAAC94 in patients with inflammatory arthritis has announce preliminary data. Within each of six cohorts, 15 patients received tgAAC94 and five received placebo, administered by injection to affected joints. At week 12 after treatment with tgAAC94, 13 percent, 14 percent and 33 percent of subjects receiving low-, mid- and high-dose tgAAC94, respectively, achieved a two-point reduction in swelling compared with none in the placebo group.
Ofatumumab Results Announced
Posted 6/18/2007
Positive primary efficacy data from a Phase II study of ofatumumab (HuMax-CD20) in patients with rheumatoid arthritis (RA) have been announced. A total of 225 patients with active RA who previously failed one or more disease-modifying, antirheumatic drugs were enrolled into this double-blind, placebo-controlled study to evaluate the safety and efficacy of ofatumumab. At 24 weeks, the patients’ immune responses to study medication (ofatumumab or placebo) were evaluated by testing for the presence of human antihuman antibodies. All patients tested negative at 24 weeks. Overall, 72 percent of patients treated with ofatumumab experienced at least a moderate response compared with 40 percent of patients receiving placebo.
Osteoarthritis Pain Relief Medication
Posted 6/14/2007
A Phase IIa study has begun to evaluate the pain-relieving efficacy of nalbuphine extended release (ER) for the treatment of chronic pain secondary to osteoarthritis of the knee or hip. Nalbuphine is a synthetic opioid analgesic that currently is available only in an injectable form. The study will employ a randomized, double-blind, placebo-controlled design, with a forced weekly dose escalation and a total dosing period of 21 days. Top-line results are expected from this Phase IIa clinical study in early 2008.
Phase l Trials for Osteoporosis Drug
Posted 6/11/2007
A Phase I clinical trial for an inhaled formulation of the osteoporosis drug teriparatide (Forteo) has begun. The open-label study is designed to assess the safety, tolerability and pharmacokinetics of inhaled Forteo in approximately 60 healthy, postmenopausal women. Top-line results from the study are expected by early 2008.
