Study Evaluating Safety and Adherence to Treatment With Etanercept in Adults With Psoriatic Arthritis

NCT00938015 | Completed Results

• 2 other identifiers: 0881A-101698B1801107
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate if the data obtained in controlled clinical trials are confirmed when Enbrel is used in usual clinical practice in Belgium according to local reimbursement criteria.

Conditions

Arthritis, Psoriatic

Keywords

postmarketing surveillance; Enbrel; psoriatic arthritis

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Baseline up to Year 1

  An adverse event (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.

  Baseline up to Year 1

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 1 up to Year 2

  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.

  Year 1 up to Year 2

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 2 up to Year 3

  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.

  Year 2 up to Year 3

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 3 up to Year 4

  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.

  Year 3 up to Year 4

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 4 up to Year 5

  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.

  Year 4 up to Year 5

• Percentage of Participants With at Least 1 Serious Adverse Event (SAE): Year 5 up to Year 6

  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.

  Year 5 up to Year 6

Secondary Outcomes (7)

• Percentage of Participants With at Least 1 Adverse Event (AE) Per Year

  Baseline up to Year 6

• Incidence of Adverse Events and Serious Adverse Events Per Participant-Year

  Baseline up to Month 6, 12, 18, 30, 42, 54, 66

• Percentage of Participants With Psoriatic Arthritis (PsA) Receiving Enbrel Who Stayed on the Treatment

  Baseline up to Month 78

• Number of Joints With Active Arthritis

  Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

• Quality of Life Assessed by Numerical Rating Scale (NRS) For Oligo-Articular Type Psoriatic Arthritis (PsA) - Participant Evaluation

  Baseline, Month 6, Month 12, Month 18, Month 30, Month 42, Month 54, Month 66, Month 78

Study Arms (2)

PsA Patients (New)

New patients

Other: Questionnaire

PsA Patients

CU patients

Other: Questionnaire

Interventions

Questionnaire OTHER

This is a non-interventional study

PsA Patients (New)

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

rheumatology centers

You may qualify if:

• Active erosive psoriatic arthritis of poly-articular type or active erosive or with joint space narrowing psoriatic arthritis of oligo-articular type
• At least 18 years old
• Have fulfilled reimbursement criteria for Enbrel in psoriatic arthritis of poly-articular type or oligo-articular type
• Physician decides to prescribe Enbrel or patient is already on Enbrel

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Related Publications (1)

• de Vlam K, Boone C, The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015 Sep-Oct;33(5):624-31. Epub 2015 Jul 23.

  PMID: 26212872 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

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: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: October 1, 2004
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: May 27, 2013

Record last verified: 2013-03

Locations

BE (1)