Arthritis, Rheumatoid
Conditions
Brief summary
This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.
Detailed description
Implemented as a Special Investigation by Central Registration System
Interventions
10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients need to be administered etanercept in order to be enrolled in the survey * Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Exclusion criteria
* Patients who have been administered etanercept 50mg once a week * Patients who have been administered etanercept 25mg once a week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Related Adverse Events | 12 weeks | Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor. |
| Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | 12 weeks | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission. |
| Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | 12 weeks | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values | 12 weeks | On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Etanercept (Renetical Recombination) Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Etanercept (Renetical Recombination) |
|---|---|
| Age, Customized <65 years | 0 participants |
| Age, Customized >=65 years | 3 participants |
| Gender Female | 3 Participants |
| Gender Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept（Genetial Recombination） | Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | At 0 week | 0 percent change | Standard Deviation 0 |
| Etanercept（Genetial Recombination） | Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | At 8 weeks | -23.58 percent change | Standard Deviation 0 |
Primary
Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept（Genetial Recombination） | Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | At 0 week | 3.55 Score | Standard Deviation 0 |
| Etanercept（Genetial Recombination） | Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) | At 8 weeks | 2.72 Score | Standard Deviation 0 |
Primary
Number of Participants With Treatment Related Adverse Events
Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
Time frame: 12 weeks
Population: The safety analysis population consisted of the participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept（Genetial Recombination） | Number of Participants With Treatment Related Adverse Events | 2 participants |
Secondary
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Time frame: 12 weeks
Population: The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept（Genetial Recombination） | Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values | Effective | 3 participants |
| Etanercept（Genetial Recombination） | Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values | Ineffective | 0 participants |
Secondary
Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values
On the basis of how well the clinical symptoms of rheumatoid arthritis were controlled at baseline, the physician assessed the clinical effect of etanercept in two grades: effective or ineffective. To assess the clinical efficacy of etanercept, the degrees of the symptoms of rheumatoid arthritis and laboratory test values were compared between at baseline and at the 12th week of the investigation.
Time frame: 12 weeks
Population: The efficacy analysis population consisted of the participants in whom the change in DAS28 (4/ESR and 3/ESR) was calculated. No descriptive statistic on the change in DAS28 (4/ESR and 3/ESR) was calculated due to a very small number of participants (n = 3).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept（Genetial Recombination） | Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values | Effective | 3 participants |
| Etanercept（Genetial Recombination） | Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values | Ineffective | 0 participants |