Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulation. 1. Unknown adverse reactions, especially serious adverse reactions 2. Incidences of adverse reactions under routine drug uses 3. Factors that may affect the safety of the drug 4. Factors that may affect the efficacy of the drug This investigation spanned 3 different studies, 0881A-101575 (alias B1801105) NCT00195403, 0881A-102018 (alias B1801112) NCT00195416 and 0881A-102212 (alias B1801113). All studies have been combined into this record.
Interventions
DRUGEtanercept
Etanercept 25mg Injection, 2 times/week
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Rheumatoid Arthritis * Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate * Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX Psoriatic Arthritis \- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs
Exclusion criteria
* Patients to whom Enbrel is contraindicated as per the local labeling * Patients with known hypersensitivity to Enbrel or any component of the product * Patients with sepsis or risk of sepsis * Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Baseline up to Day 832 | 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 serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label. |
| Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 | Baseline, Month 3 | PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 | Baseline, Month 3, 9 | Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
Countries
South Korea
Participant flow
Recruitment details
Results for three unique protocols 0881A-101575 (NCT00195403), 0881A-102018 (NCT00195416), and 0881A-102212 (protocol not registered) were summarized in a single clinical study report.
Pre-assignment details
Total of 1016 case report forms were retrieved, of these 2 were double registered. Out of 1014 participants, 16 were enrolled prior to the agreement date of the study and therefore excluded from the safety analysis population (998). Three participants had missing efficacy assessments (efficacy population = 995).
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly. | 998 |
| Total | 998 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age Continuous | 40.21 years STANDARD_DEVIATION 15.13 |
| Primary diagnosis Ankylosing Spondylitis | 520 participants |
| Primary diagnosis Psoriatic Arthritis | 3 participants |
| Primary diagnosis Rheumatoid Arthritis | 475 participants |
| Sex: Female, Male Female | 465 Participants |
| Sex: Female, Male Male | 533 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 142 / 998 |
| serious Total, serious adverse events | 3 / 998 |
Outcome results
Primary
Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3
PGA of disease activity was measured on a 0 to 10 centimeter (cm) Visual Analog Scale (VAS), with 0 cm = no disease activity and 10 cm = worst disease activity possible.
Time frame: Baseline, Month 3
Population: Efficacy population included all participants who received \>=1 dose of study medication and had the efficacy assessment within 14 days after the final administration.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 | Baseline | 7.49 cm | Standard Deviation 1.3 |
| Etanercept | Change From Baseline in Physician Global Assessment (PGA) of Disease Status at Month 3 | Change at Month 3 | -4.34 cm | Standard Deviation 1.86 |
Comparison: Change from baseline in PGA at Month 3 was evaluated using paired t-test.p-value: <0.0001t-test, 2 sided
Primary
Number of Participants With Adverse Events (AEs)
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 serious AE (SAE): death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Unexpected AEs were reported as yes or no at the investigator's determination based on current country product label.
Time frame: Baseline up to Day 832
Population: Safety population included all participants who received \>= 1 dose of study medication and had the safety assessment through appropriate follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs) | Any adverse event | 142 participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Serious adverse event | 3 participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Unexpected adverse event | 27 participants |
Secondary
Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9
Assessment of 68 joints: joints classified as either tender or not tender, pain or no pain, with limitation of motion or no limitation of motion, swollen or not swollen. An increase from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline, Month 3, 9
Population: Efficacy population included all participants who received \>=1 dose of study medication and had the efficacy assessment within 14 days after the final administration. 'N' (number of participants analyzed) = participants who were evaluable for this measure. Data for Month 9 was not analyzed because there were not enough participants for analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 | Baseline | 17.42 joints | Standard Deviation 11.37 |
| Etanercept | Change From Baseline in Number of Joints With Tenderness, Pain, Limitation of Motion or Swelling at Month 3 and 9 | Change at Month 3 | -12.67 joints | Standard Deviation 9.91 |
Comparison: Change from baseline in number of joints with tenderness, pain, and limitation of motion or swelling at Month 3 were evaluated using paired t-test.p-value: <0.0001t-test, 2 sided