Ankylosing Spondylitis, Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing
Conditions
Keywords
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
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.
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.
Interventions
OTHERThere is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Month 24 | 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 | Baseline up to Month 24 | — |
| Number of Participants by Reasons for Discontinuation of Treatment | Baseline up to Month 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month | Baseline, Month 24 | 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 | Baseline, Month 24 | 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 | Baseline, Month 24 | PGA was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity to 100 mm = worst disease activity possible. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months. | 880 |
| Total | 880 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 81 |
| Overall Study | Lost to Follow-up | 101 |
| Overall Study | Not completed 24 month observation time | 334 |
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age Continuous | 52.0 Years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 562 Participants |
| Sex: Female, Male Male | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 455 / 880 |
| serious Total, serious adverse events | 36 / 880 |
Outcome results
Primary
Number of Participants by Reasons for Discontinuation of Treatment
Time frame: Baseline up to Month 24
Population: Safety population included all participants who received at least one dose of etanercept.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants by Reasons for Discontinuation of Treatment | Lost to follow-up | 101 Participants |
| Etanercept | Number of Participants by Reasons for Discontinuation of Treatment | Withdrawal by participants | 21 Participants |
| Etanercept | Number of Participants by Reasons for Discontinuation of Treatment | AEs | 60 Participants |
| Etanercept | Number of Participants by Reasons for Discontinuation of Treatment | SAEs | 21 Participants |
Primary
Number of Participants Who Discontinued Treatment
Time frame: Baseline up to Month 24
Population: Safety population included all participants who received at least one dose of etanercept.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants Who Discontinued Treatment | 203 Participants |
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.
Time frame: Baseline up to Month 24
Population: Safety population included all participants who received at least one dose of etanercept.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 455 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 36 Participants |
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.
Time frame: Baseline, Month 24
Population: Data was not analyzed as the usage of the questionnaire was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.
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.
Time frame: Baseline, Month 24
Population: Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.
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.
Time frame: Baseline, Month 24
Population: Data was not analyzed as the usage of the scale was not considered to be part of usual clinical practice at the time of the study and thus was not to be used in the framework of a non-interventional trial.