Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.
Interventions
DRUGetanercept
Sponsors
Innovex, Inc
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have moderate to severe active rheumatoid arthritis * Be aged of 17 years or more * Have inadequate response to DMards * Give written informed consent * Physician decides to prescribe Enbrel
Exclusion criteria
n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Month 66 | Any untoward medical occurrence in a participant who received study treatment 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Completion of Study Treatment | Month 12 through Month 72 | — |
| Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Baseline, Months 6, 12, 18, 30, 42, 54 and 66 | Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac. |
| Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Baseline, Months 6, 12, 18, 30, 42, 54 and 66 | 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 possible score ranged from 0 (no difficulty) to 60 (unable to do). |
| Mean Dose of Concomitant Methotrexate (MTX) and Steroids | Baseline up to Month 66 | — |
Countries
Luxembourg
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Early closure of the site | 4 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age Continuous | 50.20 years STANDARD_DEVIATION 13.93 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 25 |
| serious Total, serious adverse events | 6 / 25 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study treatment 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 66
Population: Full analysis set (FAS) included all recruited participants who were either initiated or were already receiving etanercept.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 56 percentage of participants |
| Etanercept | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 24 percentage of participants |
Secondary
Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
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 possible score ranged from 0 (no difficulty) to 60 (unable to do).
Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66
Population: FAS included all recruited participants who were either initiated or were already receiving etanercept. 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Baseline | 32.4 units on a scale | Standard Deviation 12 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 6 (n= 6) | -13.7 units on a scale | Standard Deviation 8.4 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 12 (n= 9) | -17.0 units on a scale | Standard Deviation 7.5 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 18 (n= 10) | -17.8 units on a scale | Standard Deviation 9.8 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 30 (n= 11) | -10.4 units on a scale | Standard Deviation 14.5 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 42 (n= 9) | -20.0 units on a scale | Standard Deviation 15.3 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 54 (n= 8) | -16.6 units on a scale | Standard Deviation 14.3 |
| Etanercept | Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 66 (n= 2) | -26.5 units on a scale | Standard Deviation 13.4 |
Secondary
Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
Synovitis was defined as the inflammation of a synovial (joint-lining) membrane, usually painful, particularly on motion, and characterized by swelling, due to effusion (fluid collection) in a synovial sac.
Time frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66
Population: FAS included all recruited participants who were either initiated or were already receiving etanercept. The 'n' is signifying those participants who were evaluated for this measure at the specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 66 (n= 13) | -22.8 joints | Standard Deviation 19.2 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Baseline | 26.5 joints | Standard Deviation 15.7 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 6 (n= 14) | -20.2 joints | Standard Deviation 15.8 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 12 (n= 15) | -20.3 joints | Standard Deviation 14.1 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 18 (n= 19) | -21.4 joints | Standard Deviation 15.2 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 30 (n= 22) | -19.5 joints | Standard Deviation 16.7 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 42 (n= 20) | -24.4 joints | Standard Deviation 16.3 |
| Etanercept | Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 | Change at Month 54 (n= 18) | -24.3 joints | Standard Deviation 16.2 |
Secondary
Mean Dose of Concomitant Methotrexate (MTX) and Steroids
Time frame: Baseline up to Month 66
Population: Data was not analyzed due to low number of participants.
Secondary
Percentage of Participants With Completion of Study Treatment
Time frame: Month 12 through Month 72
Population: FAS included all recruited participants who were either initiated or were already receiving etanercept.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 30 months to 36 months | 80 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 36 months to 42 months | 80 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 42 months to 48 months | 80 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 48 months to 54 months | 68 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 54 months to 60 months | 52 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | 12 to 18 months | 100 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 18 months to 24 months | 100 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 24 months to 30 months | 92 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 60 months to 66 months | 28 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 66 months to 72 months | 12 percentage of participants |
| Etanercept | Percentage of Participants With Completion of Study Treatment | Greater than 72 months | 12 percentage of participants |