An observational study in Rheumatoid Arthritis, sponsored by Pfizer. Completed at 4 sites in Korea, Republic of. Open to participants aged 4 Years and older. Per ClinicalTrials.gov, last updated 2013-08-15.
Sponsored by Pfizer · Observational
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 1,014 is above the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary care clinic, secondary and tertiary medical centers
Rheumatoid Arthritis
Psoriatic Arthritis
Exclusion Criteria
Drug: Etanercept
Etanercept 25mg Injection, 2 times/week
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
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
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
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.
| Milestone | Etanercept |
|---|---|
| Started | 1014 |
| Completed | 1014 |
| Not completed | 0 |
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.
| participants | Etanercept |
|---|---|
| Any adverse event | 142 |
| Serious adverse event | 3 |
| Unexpected adverse event | 27 |
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.
| cm | Etanercept |
|---|---|
| Baseline | 7.49 ± 1.30 |
| Change at Month 3 | -4.34 ± 1.86 |
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.
| joints | Etanercept |
|---|---|
| Baseline | 17.42 ± 11.37 |
| Change at Month 3 | -12.67 ± 9.91 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etanercept | — | 3/998 (0.3%) | 142/998 (14.2%) |
| Event | Etanercept |
|---|---|
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 1/998 |
| GastroenteritisGastrointestinal disorders | 1/998 |
| Herpes zosterInfections and infestations | 1/998 |
| Event | Etanercept |
|---|---|
| ItchingSkin and subcutaneous tissue disorders | 36/998 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 16/998 |
| CoughRespiratory, thoracic and mediastinal disorders | 15/998 |
| Injection site itchingGeneral disorders | 12/998 |
| RashSkin and subcutaneous tissue disorders | 9/998 |
| Injection site erythemaGeneral disorders | 7/998 |
| HeadacheGeneral disorders | 7/998 |
| Sputum increasedRespiratory, thoracic and mediastinal disorders | 6/998 |
| EdemaGeneral disorders | 6/998 |
| NauseaGastrointestinal disorders | 5/998 |
Safety population included all participants who received at least (\>=) 1 dose of study medication and had the safety assessment through appropriate follow-up.
| Age Continuous(years) | Etanercept |
|---|---|
| Mean | 40.21 ± 15.13 |
| Sex: Female, Male(Participants) | Etanercept |
|---|---|
| Female | 465 |
| Male | 533 |
| Primary diagnosis(participants) | Etanercept |
|---|---|
| Ankylosing Spondylitis | 520 |
| Rheumatoid Arthritis | 475 |
| Psoriatic Arthritis | 3 |
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer