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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00273858
• Date of registration: 04/01/2006
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
• Scientific 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
• Date of first enrolment: March 2006
• Target sample size: 880
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00273858
• Study type: Observational
• Phase: N/A

Countries of recruitment

Greece

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Psoriatic

Ankylosing Spondylitis

Spondylitis, Ankylosing

Arthritis, Rheumatoid

Intervention(s)

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

Primary Outcome(s)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline up to Month 24]

Number of Participants by Reasons for Discontinuation of Treatment [Time Frame: Baseline up to Month 24]

Number of Participants Who Discontinued Treatment [Time Frame: Baseline up to Month 24]

Secondary Outcome(s)

Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month [Time Frame: Baseline, Month 24]

Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month [Time Frame: Baseline, Month 24]

Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month [Time Frame: Baseline, Month 24]

Secondary ID(s)

B1801106

0881A-101695

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/07/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00273858