Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full Analysis Set | Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-intervention | Other | observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Any contraindication according to the Austrian SmPC, which includes:
A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
Patient has previously participated in this study.
Not provided
Not provided
Not provided
Patients with moderately active RA that are treated with Etanercept will be studied. All patients enrolled should meet the usual prescribing criteria for Etanercept as per the Austrian SmPC and should be entered into the study at the investigator's discretion.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ordination Dr. Thomas Muller | Graz | 8010 | Austria | |||
| Barmherzige Brüder Graz Eggenberg |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 12 and Week 52 |
| 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. | Baseline, Week 12, Week 24, Week 52 |
| Graz |
| 8020 |
| Austria |
| Ordination Dr. Horst Just | Klagenfurt | 9020 | Austria |
| Ordination Dr. Richard Janetschko | Linz | 4020 | Austria |
| Ordination Dr. Wilhelm Kaiser | Linz | 4030 | Austria |
| Dr. Eichbauer-Sturm | Linz | 4040 | Austria |
| Rheumazentrum Oberlaa | Vienna | 1100 | Austria |
| Ordination Dr. Peter Peichl | Vienna | 1130 | Austria |
| Ordination Dr. Maya Thun | Vienna | 1170 | Austria |
| Ordination Dr. Thomas Schwingenschlogl | Wiener Neudorf | 2351 | Austria |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS) included any participants who had given written informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
|
|
| |||||||||||||||||||||||||
| 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. | FAS included any participants who had given written informed consent. | Posted | Number | percentage of participants | Week 12 and Week 52 |
|
| |||||||||||||||||||||||||||
| 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. | FAS included any participants who had given written informed consent. Here, "number analyzed" signifies participants who were evaluable at specified categories. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 52 |
|
|
Baseline up to Week 52
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 8 | 76 | 16 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Disease recurrence | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Disease recurrence | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Participants |
|
|
|