Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing |
Other: There is no Intervention. The study is observational. |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]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.
- Number of Participants Who Discontinued Treatment [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]
- Number of Participants by Reasons for Discontinuation of Treatment [ Time Frame: Baseline up to Month 24 ] [ Designated as safety issue: Yes ]
- Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]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.
- Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad.
- Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible.
| Enrollment: | 880 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
The study is observational and the prescription follows the SmPC of etanercept.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
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
Contacts and Locations| Greece | |
| Pfizer Investigational Site | |
| Thessaloniki, Asvestohori, Greece, 570 10 | |
| Pfizer Investigational Site | |
| Athens, Maroussi, Greece, 145 61 | |
| Pfizer Investigational Site | |
| Athens, Greece, 16673 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 26 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 27 | |
| Pfizer Investigational Site | |
| Athens, Greece, 184 54 | |
| Pfizer Investigational Site | |
| Karditsa, Greece, 43100 | |
| Pfizer Investigational Site | |
| Larissa, Greece, 411 10 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 546 42 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00273858 History of Changes |
| Other Study ID Numbers: | 0881A-101695, B1801106 |
| Study First Received: | January 4, 2006 |
| Results First Received: | June 30, 2011 |
| Last Updated: | September 8, 2011 |
| Health Authority: | Greece: National Organization of Medicines |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013