Ankylosing Spondylitis
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CLINICAL_TRIALS trial_result · 2008-06-03Clinical Trial Update: Examination of Radiographic Progression, Efficacy and Safety of Long-Term Treatment With Infliximab in Patients With Ankylosing Spondylitis [NA]
This ClinicalTrials.gov update reports on the long-term use of infliximab in ankylosing spondylitis, examining radiographic progression, eff…
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CLINICAL_TRIALS trial_result · 2008-04-22Clinical Trial Update: Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. [Phase 3]
A completed Phase 3 trial compared PN 200 with naproxen to evaluate the incidence of gastric ulcers in subjects at risk for NSAID-associated…
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CLINICAL_TRIALS trial_result · 2008-04-10Clinical Trial Update: Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis [Phase 3]
Phase 3 trial comparing celecoxib to diclofenac in ankylosing spondylitis has completed, evaluating comparative safety and efficacy.
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CLINICAL_TRIALS trial_result · 2008-03-13Clinical Trial Update: Study Evaluating Etanercept in Patients With Ankylosing Spondylitis [Phase 4]
Wyeth (now a Pfizer subsidiary) sponsored a Phase 4 trial evaluating etanercept in Ankylosing Spondylitis. The study status is completed.
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CLINICAL_TRIALS trial_result · 2008-02-26Clinical Trial Update: Pilot Open Label Clinical Trial With Abatacept in Ankylosing Spondylitis [Phase 2]
This document reports on a pilot open-label Phase 2 clinical trial evaluating abatacept in patients with ankylosing spondylitis.
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CLINICAL_TRIALS research · 2008-02-21Clinical Trial Update: Genetics of Ankylosing Spondylitis
A NIAMS-sponsored genetic study on ankylosing spondylitis has completed. The update summarizes findings related to the genetics of the disea…
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EMA withdrawal · 2008-02-14EMA Withdrawn: Trudexa (adalimumab) — Abbott Laboratories Ltd.
EMA has withdrawn Trudexa (adalimumab) from the market.
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FDA approval · 2008-02-05FDA Approved: SULINDAC — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for sulindac from Actavis Pharma, Inc. This action updates the labeling for the drug under the appro…
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FDA approval · 2008-01-14FDA Approved: CELEBREX — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for Celebrex (celecoxib) submitted by Viatris Specialty LLC to update the product labeling under NDA…
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CLINICAL_TRIALS trial_result · 2007-12-13Clinical Trial Update: Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis [Phase 3]
Wyeth (now Pfizer) completed a Phase 3 trial evaluating etanercept for ankylosing spondylitis.
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CLINICAL_TRIALS trial_result · 2007-12-10Clinical Trial Update: Study Evaluating Enbrel (Etanercept) in Patients With Ankylosing Spondylitis
A completed clinical trial evaluating etanercept (Enbrel) in patients with Ankylosing Spondylitis; sponsor Wyeth is now a subsidiary of Pfiz…
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CLINICAL_TRIALS trial_result · 2007-12-07Clinical Trial Update: An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis [Phase 4]
This is an open-label, multicenter long-term extension study of etanercept in ankylosing spondylitis (Phase 4), which has completed.
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FDA approval · 2007-11-07FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen (generic Naproxen) from Hikma Pharmaceuticals USA Inc., resulting in approval of a gene…
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FDA approval · 2007-10-25FDA Approved: MELOXICAM — Supplemental Application (AiPing Pharmaceutical, Inc)
FDA approved a supplemental application for MELOXICAM from AiPing Pharmaceutical, Inc., resulting in the availability of a generic meloxicam…
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CLINICAL_TRIALS trial_result · 2007-10-10Clinical Trial Update: An Open-Label Study to Evaluate the Response to Adalimumab in Patients With Active Ankylosing Spondylitis Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY) [Phase 3]
Completed Phase 3 open-label trial evaluating the response to adalimumab in active ankylosing spondylitis patients who have failed standard …
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FDA approval · 2007-09-25FDA Approved: NAPROXEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Naproxen from Hikma Pharmaceuticals USA Inc., indicating an approved change or addition to the N…
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FDA approval · 2007-08-24FDA Approved: DICLOFENAC SODIUM AND MISOPROSTOL — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for the Diclofenac sodium and misoprostol combination product from Mylan Pharmaceuticals.
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CLINICAL_TRIALS research · 2007-08-16Clinical Trial Update: Presence of IBD Specific Antibodies (ASCA, ALCA, ACCA, AMCA) in the Sera of Patients With Spondyloarthropathy
A clinical trial investigates whether inflammatory bowel disease–associated antibodies (ASCA, ALCA, ACCA, AMCA) are present in the blood of …
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FDA approval · 2007-07-30FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)
The FDA approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.
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FDA approval · 2007-07-26FDA Approved: NAPROXEN SODIUM — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approves Dr. Reddy's Laboratories' naproxen sodium as a generic version via an Original Abbreviated New Drug Application (ANDA). This co…
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FDA approval · 2007-06-12FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
FDA approved a supplemental application for infliximab (Remicade) submitted by Janssen Biotech, Inc. The approval updates the labeling to re…
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FDA approval · 2007-04-19FDA Approved: INFLIXIMAB — Supplemental Application (Janssen Biotech, Inc.)
The FDA approved a supplemental application for infliximab (Remicade) from Janssen Biotech, Inc., updating the product labeling per the supp…
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CLINICAL_TRIALS trial_result · 2007-04-10Clinical Trial Update: TNFalfa Blocking Treatment of Spondylarthropathies [Phase 4]
Phase 4 clinical trial evaluating TNF-alpha blockade for spondyloarthropathies has completed, including ankylosing spondylitis and psoriatic…
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CLINICAL_TRIALS trial_result · 2007-02-27Clinical Trial Update: Study of Two Schedules of Infliximab Maintenance Therapy in Ankylosing Spondylitis [Phase 3]
A Phase 3 trial update reports two schedules of infliximab maintenance therapy in Ankylosing Spondylitis; the study status is completed.
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CLINICAL_TRIALS research · 2007-02-08Clinical Trial Update: Open Label Clinical Trial With Rituximab (MabThera ®) in Ankylosing Spondylitis [Phase 2, Phase 3]
Open-label phase 2/3 trial evaluating rituximab (MabThera) in ankylosing spondylitis; status is not specified in the document.