Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

NCT00273858 | Terminated Results

• 2 other identifiers: 0881A-101695B1801106
• Study Type: observational
• Target: 880
• Locations: 1 country
• Sites: 9

Brief Summary

This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.

Conditions

Ankylosing Spondylitis; Arthritis, Psoriatic; Arthritis, Rheumatoid; Spondylitis, Ankylosing

Keywords

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline up to Month 24

• Number of Participants Who Discontinued Treatment

  Baseline up to Month 24

• Number of Participants by Reasons for Discontinuation of Treatment

  Baseline up to Month 24

Secondary Outcomes (3)

• Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month

  Baseline, Month 24

• Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month

  Baseline, Month 24

• Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month

  Baseline, Month 24

Study Arms (1)

etanercept

Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).

Other: There is no Intervention. The study is observational.

Interventions

There is no Intervention. The study is observational. OTHER

The study is observational and the prescription follows the SmPC of etanercept.

etanercept

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

Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients

You may qualify if:

• years of age or older at time of consent
• Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis or has a diagnosis of ankylosing spondylitis or psoriatic arthritis, as determined by the doctor
• Provides informed consent
• Demonstrate a negative serum or urine pregnancy test prior to administration of etanercept. Sexually active women participating in the study must use a medically acceptable form of contraception.
• Patients already prescribed etanercept according to approved labelling

You may not qualify if:

• Has hypersensitivity to etanercept
• Has sepsis or risk of sepsis. Treatment with etanercept should not be initiated in patients with active infections (ie. hepatitis C, hepatitis B, active TBC)
• Is pregnant or breast-feeding
• Has significant concurrent medical diseases including, uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, or history of human immunodeficiency virus (HIV) infection, immunodeficiency syndromes, or central nervous system (CNS) demyelinating events suggestive of multiple sclerosis
• Has a history of confirmed blood dyscrasias
• Received any live (attenuated) vaccines within 4 weeks of screening visit

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Thessaloniki, Asvestohori, 570 10, Greece

Location

Pfizer Investigational Site

Athens, Maroussi, 145 61, Greece

Location

Pfizer Investigational Site

Athens, 115 26, Greece

Location

Pfizer Investigational Site

Athens, 115 27, Greece

Location

Pfizer Investigational Site

Athens, 16673, Greece

Location

Pfizer Investigational Site

Athens, 184 54, Greece

Location

Pfizer Investigational Site

Karditsa, 43100, Greece

Location

Pfizer Investigational Site

Larissa, 411 10, Greece

Location

Pfizer Investigational Site

Thessaloniki, 546 42, Greece

Location

Related Links

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

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis, Psoriatic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

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: January 4, 2006
• First Posted: January 9, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 12, 2011
• Results First Posted: July 28, 2011

Record last verified: 2011-09

Locations

GR (9)