Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase III study published in The Lancet showed patients with active psoriatic arthritis who received either Stelara (ustekinumab) 45 mg or 90 mg achieved significant improvement in joint symptoms at the study's primary endpoint, compared to patients receiving placebo
The primary endpoints are immunogenicity evaluated 21 days after each administration, as well as safety and tolerability after each administration and 12 months after the last injection
The primary endpoint of the Phase II cohort is to assess the complete remission rate...The primary endpoint of the study is to demonstrate efficacy, tolerability and safety of TI-001, with the secondary goal of determining the best Phase III dosage and exploring interlukin-6 levels as a potential biomarker for predicting efficacy
The study met its primary endpoint of lowering LDL-C, which it did by an average of 32 percent...The primary endpoints of the trial will be progression-free survival and overall survival
In the SET study, tasimelteon achieved the primary endpoints of entrainment (synchronizing) of the melatonin (aMT6s) rhythm as compared to placebo and clinical response as measured by entrainment plus a score of greater than or equal to 3 on the Non-24 Clinical Response Scale
The Phase III randomized, placebo-controlled study will assess efficacy and safety of the drug with a primary endpoint as change in truncal fat mass from baseline to six months after beginning treatment
ALKS 5461 met its primary endpoint, met key secondary endpoints and demonstrated significant reduction in depressive symptoms versus placebo...The primary endpoint for the trial is progression-free survival. (See BioWorld Today, Aug. 7, 2012
Amitifadine efficacy at 50-mg or 100-mg doses did not show a statistically significant difference from placebo in the primary endpoint of a change in MADRS (Montgomery-Åsberg Depression Rating Scale...The Phase IIb study is a double-blind, placebo-controlled, randomized, parallel group trial planned to be conducted at sites in the U.S. The study's co-primary endpoints are change in micturition frequency per 24 hours and change in urinary incontinence episodes per 24 hours, in each case from
Results from the study's primary endpoint showed that at 18 months, both Forteo and risedronate significantly increased lumbar spine vBMD, and greater increases were observed in patients taking Forteo (mean change from baseline: 16.3% vs. 3.8%; p = 0.004...chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL) met its primary endpoint of progression-free survival (PFS) as assessed by an independent review committee (IRC
In a meeting between the agency and the company, it was agreed that the primary indication and label for Proellex-V should be for treatment of severe menstrual bleeding associated with fibroids, using the Pictorial Blood Loss Assessment as primary endpoint, and that if the company proposes a label based on patient-reported outcome, that must be validated prior to the start of Phase III...While the primary endpoint is safety, secondary objectives include an analysis of dose vs
The exploratory analysis identified a more robust response to CERE-120 in Parkinson's patients diagnosed within five years prior to treatment relative to those diagnosed 10 years or older (p < 0.005), as measured by change from baseline on the Unified Parkinson's Disease Rating Scale, the primary endpoint...Previously, Ceregene reported the primary endpoint was not met for the overall study population, although a key secondary endpoint of diary-hours off demonstrated statistical significance and no
Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter...Overall survival will be the primary endpoint
Patients treated with afatinib lived for almost a year before their tumor started to grow again (progression-free survival [PFS], the primary endpoint) as compared with just under six months for patients treated with gemcitabine/cisplatin...In the study, at Day 28 (primary endpoint, p = 0.26), 24 percent of treated patients achieved resolution compared to 12 percent in the sham injection arm
The randomized, placebo-controlled trial achieved statistical significance for its primary endpoint of mean number of oral ulcers at week 12