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

NCT00293722 | Completed Results

• 2 other identifiers: 0881A6-102064B1801127
• Study Type: observational
• Target: 1,308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis, Psoriatic; Psoriasis; Skin Diseases, Papulosquamous

Keywords

Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

  Baseline up to Week 52

Secondary Outcomes (9)

• Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52

  Baseline, Week 52

• Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52

  Baseline, Week 52

• Change From Baseline in Ritchie Index at Week 52

  Baseline, Week 52

• Change From Baseline in Physician Global Assessment of Disease Activity at Week 52

  Baseline, Week 52

• Number of Participants With Nail Involvement

  Baseline, Week 12, 52

Other Outcomes (1)

• Change From Baseline in Patient Global Assessment of Disease Activity at Week 52

  Baseline, Week 52

Study Arms (1)

Patients with Psoriatic Arthritis

Drug: Etanercept

Interventions

Etanercept DRUG

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.

Patients with Psoriatic Arthritis

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

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

You may qualify if:

• Clinical diagnosis of psoriatic arthritis

You may not qualify if:

• Sepsis or risk for sepsis,
• Acute infection,
• Hypersensitivity against Etanercept

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Toerwang-Samerberg, 83122, Germany

Location

Related Publications (1)

• Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1.

  PMID: 29606665 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Skin Diseases, Papulosquamous; Arthritis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; 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

Limitations and Caveats

Results for Psoriasis Area and Severity Index (PASI) was not reported since it was not to be analyzed by rheumatologists as part of this study, as per planned analysis.

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: February 15, 2006
• First Posted: February 17, 2006
• Study Start: January 1, 2006
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 26, 2014
• Results First Posted: February 26, 2014

Record last verified: 2014-01

Locations

DE (1)