Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings

NCT00708708 | Completed Results

• 2 other identifiers: 0881X1-4499B1801081
• Study Type: observational
• Target: 926
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany.

Conditions

Psoriasis

Keywords

Plaque-type psoriasis

Outcome Measures

Primary Outcomes (5)

• Duration of Drug-Free Interval Prior to Treatment Cycle 2

  Average duration of participant's drug-free interval between the end of treatment Cycle 1 and Cycle 2 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

  Cycle 1 Week 24 up to Cycle 2 Week 0

• Duration of Drug-Free Interval Prior to Treatment Cycle 3

  Average duration of participant's drug-free interval between the end of treatment Cycle 2 and Cycle 3 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

  Cycle 2 Week 24 up to Cycle 3 Week 0

• Duration of Drug-Free Interval Prior to Treatment Cycle 4

  Average duration of participant's drug-free interval between the end of treatment Cycle 3 and Cycle 4 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

  Cycle 3 Week 24 up to Cycle 4 Week 0

• Duration of Drug-Free Interval Prior to Treatment Cycle 5

  Average duration of participant's drug-free interval between the end of treatment Cycle 4 and Cycle 5 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

  Cycle 4 Week 24 up to Cycle 5 Week 0

• Duration of Drug-Free Interval Prior to Treatment Cycle 6

  Average duration of participant's drug-free interval between the end of treatment Cycle 5 and Cycle 6 was reported in weeks. Duration of drug-free interval was computed as: (date of start of new treatment cycle minus date of last application of etanercept prior to drug free interval plus 1) divided by 7 and it was determined for only those participants who had information available regarding drug-free interval.

  Cycle 5 Week 24 up to Cycle 6 Week 0

Secondary Outcomes (35)

• Psoriasis Area and Severity Index (PASI) Score

  Week 0, 12, 24 of Cycle 1 to 6

• Percentage of Body Surface Area (BSA) Affected by Psoriasis

  Week 0, 12, 24 of Cycle 1 to 6

• Static Physician Global Assessment (sPGA) of Disease Activity

  Week 0, 12, 24 of Cycle 1 to 6

• Physician Global Assessment of Efficacy

  Week 24 of Cycle 1 to 6

• Patient Global Assessment of Efficacy

  Week 24 of Cycle 1 to 6

Study Arms (1)

A

Patients with moderate to severe plaque psoriasis

Drug: etanercept (Enbrel®)

Interventions

etanercept (Enbrel®) DRUG

The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate to severe plaque psoriasis

You may qualify if:

• Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
• Subjects for whom the decision has already been made to initiate treatment with etanercept

You may not qualify if:

• Sepsis or risk of sepsis
• Current or recent infections, including chronic or localized, e.g. tuberculosis (TB) infection
• Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination during the course of the study
• Pre-existing or recent onset CNS demyelinating disease.
• Class III or IV congestive heart failure as defined by the New York Heart Association classification or uncompensated congestive heart failure.
• Previous or ongoing treatment with etanercept
• Participation in other clinical or observational studies.
• Patients with psoriatic arthritis requiring continuous etanercept treatment.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Westfaelische Wilhelms-Universitaet Muenster, Zentr. f. Derm

Münster, North Rhine-Westphalia, 48149, Germany

Location

Related Publications (1)

• Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Loschmann PA. An observational study to evaluate the long-term outcomes of treatment with etanercept in patients with plaque-type psoriasis. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1730-1741. doi: 10.1111/jdv.13673. Epub 2016 Jun 14.

  PMID: 27297981 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-07

Locations

DE (1)