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Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00293722
First received: February 15, 2006
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.


Condition Intervention
Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
 Drug: Etanercept

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists

Resource links provided by NLM:

Drug Information available for: Etanercept
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidences of adverse events for patients with psoriatic arthritis (PsA) in usual care setting [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination of the Psoriasis area and severity index (PASI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of involved body surface area (BSA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physician`s global assessment of disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Patient`s global assessment of disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: January 2006
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Psoriatic Arthritis Drug: Etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Detailed Description:

Non-interventional study: subjects to be selected according to the usual clinical practice of their physician

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis

Criteria

Inclusion Criteria:

  • Clinical diagnosis of psoriatic arthritis

Exclusion Criteria:

  • Sepsis or risk for sepsis,
  • Acute infection,
  • Hypersensitivity against Etanercept
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00293722

Locations
Germany
Pfizer Investigational Site
Toerwang-Samerberg, Germany, 83122
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00293722     History of Changes
Other Study ID Numbers: 0881A6-102064, B1801127
Study First Received: February 15, 2006
Last Updated: May 14, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pfizer:
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013