Psoriatic Arthritis

• FDA approval · 2012-12-04
  FDA Approved: ENBREL — Supplemental Application (Immunex Corporation)

  FDA approved a supplemental application for Enbrel (etanercept) submitted by Immunex Corporation.

• CLINICAL_TRIALS trial_result · 2012-11-29
  Clinical Trial Update: Study Evaluating The Prevalence Of Undiagnosed Psoriatic Arthritis In Patients With Plaque Psoriasis

  A Pfizer-sponsored observational study completed to assess how common undiagnosed psoriatic arthritis is among patients with plaque psoriasi…

• FDA approval · 2012-09-28
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA approved a supplemental application for HUMIRA (adalimumab) submitted by Cordavis Limited.

• CLINICAL_TRIALS trial_result · 2012-09-12
  Clinical Trial Update: Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)

  A post-marketing surveillance study of infliximab (Remicade) in chronic inflammatory diseases has completed, with results posted in 2012. Th…

• CLINICAL_TRIALS trial_result · 2012-09-05
  Clinical Trial Update: An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis [Phase 2]

  A Phase 2 trial evaluating the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with active psoriatic arthritis; the study is…

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• CLINICAL_TRIALS withdrawal · 2012-08-10
  Clinical Trial Update: Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine

  The study evaluating Humira (adalimumab) for psoriatic arthritis, including safety, effectiveness, and effects on quality of life and work p…

• CLINICAL_TRIALS research · 2012-07-30
  Clinical Trial Update: Study Evaluating the Cost of the Treatments of the Refractory Psoriatic Arthritis to the Conventional Therapy

  Pfizer-sponsored study evaluating the costs of treatments for refractory psoriatic arthritis compared with conventional therapy; the trial s…

• CLINICAL_TRIALS trial_result · 2012-06-21
  Clinical Trial Update: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice [Phase 4]

  A Phase 4 study estimates how common psoriatic arthritis is among adults with psoriasis based on dermatology practice data; results were pos…

• FDA approval · 2012-05-24
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2012-05-02
  FDA Approved: USTEKINUMAB — Supplemental Application (Janssen Biotech, Inc.)

  FDA approved a supplemental application for ustekinumab (Stelara) from Janssen Biotech, Inc., resulting in a labeling change/addition.

• FDA approval · 2012-04-17
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for CIMZIA (certolizumab pegol) submitted by UCB, Inc.

• CLINICAL_TRIALS trial_result · 2012-04-16
  Clinical Trial Update: A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis [Phase 3]

  Phase 3 study evaluating golimumab in active psoriatic arthritis shows safety and efficacy results; results were posted in 2012.

• CLINICAL_TRIALS trial_result · 2012-03-21
  Clinical Trial Update: PsA Treatment With hOKT3γ1 (Ala-Ala) [Phase 2]

  Phase 2 trial of the immunomodulatory agent hOKT3γ1 (Ala-Ala) for psoriatic arthritis has been terminated, with results posted in 2012.

• CLINICAL_TRIALS trial_result · 2012-01-18
  Clinical Trial Update: Rituxan With or Without Methotrexate in Psoriatic Arthritis [Phase 1]

  Phase 1 trial evaluating rituximab with or without methotrexate in psoriatic arthritis has completed. The update does not include efficacy o…

• CLINICAL_TRIALS trial_result · 2012-01-16
  Clinical Trial Update: Centocor Microarray Study of Patients [Phase 4]

  This is a Phase 4 clinical trial update (Centocor Microarray Study) that has completed with results posted; the study investigated patients …

• FDA approval · 2011-12-26
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  The FDA has approved a supplemental application for Humira (adalimumab) submitted by Cordavis Limited.

• FDA approval · 2011-12-13
  FDA Approved: HUMIRA — Supplemental Application (Cordavis Limited)

  FDA approved a supplemental application for HUMIRA (adalimumab) filed by Cordavis Limited.

• CLINICAL_TRIALS trial_result · 2011-11-04
  Clinical Trial Update: HUmira in Psoriatic Arthritis [Phase 4]

  A Phase 4 clinical trial evaluating adalimumab (Humira) for psoriatic arthritis has completed.

• FDA approval · 2011-09-07
  FDA Approved: CIMZIA — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for Cimzia (certolizumab pegol) submitted by UCB, Inc. This action approves the changes described in…

• FDA approval · 2011-09-07
  FDA Approved: SIMPONI — Supplemental Application (Janssen Biotech, Inc.)

  The FDA approved a supplemental application for SIMPONI (golimumab) filed by Janssen Biotech, Inc.

• FDA approval · 2011-08-29
  FDA Approved: LEFLUNOMIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Leflunomide (generic) submitted by Chartwell RX, LLC under an ANDA, enabling market authorizatio…

• FDA approval · 2011-08-18
  FDA Approved: ORENCIA — Supplemental Application (E.R. Squibb & Sons, L.L.C.)

  FDA approved a supplemental application for Orencia (abatacept) submitted by E.R. Squibb & Sons, L.L.C.

• CLINICAL_TRIALS trial_result · 2011-07-29
  Clinical Trial Update: Investigation of 9 Consecutive Infusions of Remicade for Psoriatic Arthritis in Austria (Study P04264)

  Clinical trial update for nine consecutive infusions of Remicade (infliximab) in psoriatic arthritis; results for Study P04264 have been pos…

• CLINICAL_TRIALS trial_result · 2011-07-28
  Clinical Trial Update: Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

  This document reports a safety-focused update for a terminated trial evaluating etanercept in rheumatoid arthritis, ankylosing spondylitis, …

• CLINICAL_TRIALS trial_result · 2011-07-26
  Clinical Trial Update: Quality of Life Outcomes of HUMIRA in Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS) After Unsustainable Response to Biologicals and Disease Modifying Antirheumatic Drugs

  This trial update reports quality-of-life outcomes for Humira (adalimumab) in rheumatoid arthritis, psoriatic arthritis, and ankylosing spon…