Rheumatoid Arthritis
Conditions
Brief summary
This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.
Detailed description
Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A
Interventions
OTHERnon-intervention
observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is eligible to receive Etanercept treatment according to the Austrian SmPC. 2. The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol. 3. The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data. 4. The patient has moderately active RA, defined as a disease activity of CDAI \>10 and ≤22 and/or DAS28 (CRP)\>3.2 and ≤ 5.1
Exclusion criteria
1. Any contraindication according to the Austrian SmPC, which includes: A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection. 2. Patient has previously participated in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 | Week 24 | CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low disease activity, greater than (\>) 10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with CDAI remission (score \<=2.8) at Week 24 were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Week 12 and Week 52 | CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 | Baseline, Week 12, Week 24, Week 52 | CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. |
Countries
Austria
Participant flow
Pre-assignment details
A total of 111 participants were enrolled in the study but due to the loss of all study data and material at one site with 35 participants, the number of participants that could be included in the analysis was 76.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants with moderately active rheumatoid arthritis (RA), who received etanercept as per physician's discretion based on Austrian summary of product characteristics (SmPC) were observed prospectively up to Week 52. According to Austrian SmPC, recommended dose included etanercept 25 milligrams (mg) twice weekly, or 50 mg once weekly subcutaneous injection. | 76 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Data not available | 35 |
| Overall Study | Disease Remission | 1 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Other | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 14.9 |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 76 |
| serious Total, serious adverse events | 8 / 76 |
Outcome results
Primary
Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
CDAI is a simplified index for assessing the disease activity comprising of the swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\<=) 2.8 indicates disease remission, greater than (\>) 2.8 to 10 = low disease activity, greater than (\>) 10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with CDAI remission (score \<=2.8) at Week 24 were reported.
Time frame: Week 24
Population: Eligible Set included all participants who had given written informed consent and had received at least one dose of etanercept with evaluable CDAI assessments at baseline and Week 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 | 44.3 percentage of participants |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52
CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Baseline, Week 12, Week 24, Week 52
Population: FAS included any participants who had given written informed consent. Here, number analyzed signifies participants who were evaluable at specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 | Baseline | 25.75 units on a scale | Standard Deviation 8.195 |
| Etanercept | Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 | Change at Week 12 | -19.09 units on a scale | Standard Deviation 7.903 |
| Etanercept | Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 | Change at Week 24 | -20.45 units on a scale | Standard Deviation 8.746 |
| Etanercept | Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52 | Change at Week 52 | -22.58 units on a scale | Standard Deviation 7.732 |
Secondary
Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52
CDAI is a simplified index for assessing the disease activity comprising of the SJC, TJC, PtGA and PGA. CDAI is the numerical sum of 4 outcome parameters: SJC, TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \> 2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. Percentage of participants with different type of CDAI status of disease activity (remission, low disease, moderate and high disease activity) at Week 12 and 52 were reported. Only those categories in which at least 1 participant had data were reported.
Time frame: Week 12 and Week 52
Population: FAS included any participants who had given written informed consent.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | High disease activity At Week 12 | 2.6 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Remission At Week 52 | 48.7 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Remission At Week 12 | 22.4 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Low disease activity At Week 12 | 50.0 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Moderate disease activity At Week 12 | 11.8 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Low disease activity At Week 52 | 19.7 percentage of participants |
| Etanercept | Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52 | Moderate disease activity At Week 52 | 7.9 percentage of participants |