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

Arthritis, Rheumatoid Clinical Trial

Official title:

Open Label Study To Evaluate The Safety Profile And The Quality Of Life In Patients Receiving Etanercept For The Treatment Of Rheumatoid Arthritis, Ankylosing Spondylitis And Psoriatic Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00273858
• Other study ID #: 0881A-101695
• Secondary ID: B1801106
• Status: Terminated
• Phase: N/A
• First received: January 4, 2006
• Last updated: September 8, 2011
• Start date: March 2006
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

Description:

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).

Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 880
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• There is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.

Locations

Country	Name	City	State
Greece	Pfizer Investigational Site	Athens	Maroussi
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Karditsa
Greece	Pfizer Investigational Site	Larissa
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki	Asvestohori

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Number of Participants Who Discontinued Treatment		Baseline up to Month 24	Yes
Primary	Number of Participants by Reasons for Discontinuation of Treatment		Baseline up to Month 24	Yes
Secondary	Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month	HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores as 'normal' (no difficulty=0), 'adequate' (some difficulty= 1), 'limited' (much difficulty=2), and 'unable to do' (=3) based on degree of difficulty they experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. HAQ total scores were expressed as overall mean score ranging from 0 to 3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; greater than 1=significant functional limitation.	Baseline, Month 24	No
Secondary	Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month	PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.	Baseline, Month 24	No
Secondary	Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month	PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.	Baseline, Month 24	No

External Links

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