Pfizer Inc. Pfizer Announces Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials. Detailed Results from OPT Pivotal Studies Along with Integrated Analysis of Safety Data from Psoriasis Global Clinical Development Program Presented at 73rd American Academy of Dermatology (AAD) Annual Meeting. The first primary endpoint of OPT Retreatment evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to patients who were switched to placebo (withdrawal phase). The results from this study will be included in the planned tofacitinib psoriasis submission package to regulatory authorities in various markets. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial completion dates as well as the possibility of unfavorable clinical trial results; whether an sNDA will be submitted in the U. Pfizer announced its Oral Psoriatic Arthritis TriaL (OPAL) BROADEN study of 5-mg and 10-mg daily tofacitinib for the treatment of adult patients with active psoriatic arthritis met primary efficacy goals of ACR20 response superior to placebo at 3 months, according to a press release. Tofacitinib meets primary endpoints in psoriatic arthritis phase 3 trial.
Pfizer announced Tuesday that a Phase III study of tofacitinib for the treatment of psoriatic arthritis met its primary efficacy endpoints. Pfizer’s JAK inhibitor meets endpoints in Phase III ulcerative colitis trials. The company presented the results of the OCTAVE Induction 1 and OCTAVE Induction 2 clinical trials at the 11th congress of ECCO (European Crohn’s and Colitis Organisation). Pfizer’s tofacitinib shows promise for psoriatic arthritis treatment in Phase III trial. Pfizer’s phase 3 trial of investigational tofacitinib in adults with psoriatic arthritis meets primary efficacy endpoints.
Pfizer Says OPAL Broaden Phase 3 Study Meets Primary Efficacy Endpoints. ( PFE ) Tuesday said its phase 3 placebo controlled Oral Psoriatic Arthritis triaL or OPAL Broaden met its primary efficacy endpoints for the treatment of psoriatic arthritis. The company said the study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily in adult patients with active psoriatic arthritis. A Phase 3 clinical trial, called OPAL Broaden, evaluating Pfizer’s (PFE) rheumatoid arthritis ((RA)) med XELJANZ (tofacitinib citrate) in adult patients wi. Xeljanz, late-stage study in psoriatic arthritis meets primary endpoints. The primary endpoints of the study are safety and tolerability of AST-005, and secondary endpoints include in situ inflammatory infiltrate thickness and assessment of target knockdown in the treated psoriatic skin using gene expression analysis. Pfizer Reports Top-Line Trial Results For Tofacitinib.
Pfizer’s Xeljanz Hits Main Goals Of Phase Iii Study In Patients With Psoriatic Arthritis
In April 2011, Pfizer reported that all primary endpoints were met. Oral Tofacitinib Meets Primary Endpoints In Pivotal Phase 3 Psoriasis Trials. Tofacitinib for the treatment of moderate-to-severe psoriasis. Pfizer. Pfizer announces oral tofacitinib meets primary endpoints in pivotal Phase 3 psoriasis trials. Patient-reported outcomes from a Phase 3 study of baricitinib in patients with rheumatoid arthritis (RA) and an inadequate response to tumor necrosis factor inhibitors. CLINICAL NEWS: Sunovion’s SUN-101 meets in COPD Phase IIIs. CLINICAL NEWS: Clearside’s Zuprata reduces Eylea need in Phase II trial. Phase III trials for chronic HBV drug meet primary endpoints bit.ly/1qLo2AE. This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Further study details as provided by Pfizer:. Pfizer announced top-line results from two Phase III induction trials of Xeljanz (tofacitinib) 10 mg twice daily (BID) tablets in the OCTAVE global clinical development program for the treatment of ad. Pfizer announced top-line results from two Phase III induction trials of Xeljanz (tofacitinib) 10 mg twice daily (BID) tablets in the OCTAVE global clinical development program for the treatment of ad. Two phase III trials of Xeljanz (tofacitinib) in ulcerative colitis meet primary endpoints- Pfizer 19-Mar-2016 Gastroenterology.
Pfizer Says Opal Broaden Phase 3 Study Meets Primary Efficacy Endpoints
The trial achieved its primary and secondary endpoints of lower viral load, improvements in total mucus weight and also symptom diary score compared to placebo. Pfizer’s phase III OPT retreatment trial of tofacitinib meets primary efficacy endpoints. US-based Pfizer reported detailed results from the Oral treatment Psoriasis Trial (OPT) Retreatment study (A3921111), a Phase III trial evaluating tofacitinib, an oral Janus kinase (JAK) inhibitor, to treat adult patients with moderate-to-severe chronic plaque psoriasis. The primary outcome measure of the planned Phase III trial is to evaluate the efficacy of each secukinumab regimen in patients with active AS based on the proportion of patients obtaining an ASAS 20 response. Phase III trials for plaque psoriasis with tofacitinib compared with placebo are expected to collect final data for analysis in the first half of 2013 with a long-term safety study being completed in May 2017. Abbott’s Humira (adalimumab) meets primary endpoints in phase III ulcerative colitis study. Pfizer development pipeline shows advances in high-priority disease areas. Pfizer Announces Primary Endpoints Met In Second Phase 3 Clinical Trial Of Tofacitinib (CP-690,550) In Patients With Active Rheumatoid Arthritis Detailed Results to be Submitted to Future. Pfizer is also studying orally administered tofacitinib in psoriasis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis) and renal transplant, and topical tofacitinib in both psoriasis and dry eye disease. 20 Mar 2015. The detailed OPT Compare study results mark the completion of the first Phase 3 trial for tofacitinib in psoriasis.