Trial · NCT00488475
Observational Trial With Enbrel
NCT00488475, Completed, Pfizer; results first posted 2014-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Observational Trial With Enbrel. Trials, record NCT00488475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00488475
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Trial With Enbrel
- NCT number
- NCT00488475
- Status
- Completed
- Enrollment
- 4,945 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Rheumatoid Arthritis
- Interventions
- etanercept
- First posted
- 2007-06-20
- Last updated
- 2014-08-01
- Results first posted
- 2014-05-15
- Limitations and caveats
- Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 | Week 26 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100% \[percent\]) / (2 \* number of answered questions) ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%. |
| Primary | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 | Week 52 | Hannover Functional Ability Questionnaire (FFbH) consists 18 questions to assess daily activities in last 7 days. Each question is answered by the participant as "Yes, I can perform the activity without difficulty" (score assigned = 2), "Yes, but with some difficulties" (score assigned = 1) and "No or only with help" (score assigned = 0). Final FFbH score (FFbH functional capacity) is then computed according to formula: (Sum of all single scores \* 100%) / (2 \* number of answered questions), ranging between 0-100; higher score indicates better daily activities. FFbH functional remission is defined as FFbH functional capacity of \>= 83%. |
| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline, Week 26, Week 52 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Baseline, Week 26, Week 52 | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health state profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol group assigns a utility value for each domain in the profile. EQ-5D score is transformed to EQ-5D-TTO score ranging from -0.205 to 0.999; higher score indicates a better health state. |
| Secondary | Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | Baseline, Week 26, Week 52 | WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. |
| Secondary | Healthcare Resource Utilization | Baseline, Week 26, Week 52 | Participants' utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation. |
| Secondary | Duration of Healthcare Resources Utilization | Baseline, Week 26, Week 52 | Participants' duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation. |
| Secondary | Duration of Working Disability | Baseline, Week 26, Week 52 | Duration of working disability was assessed as number of days a participant was disable to work. Duration of work disability was considered as "0" if participant was not disable to work during period of assessment. At baseline, participants' duration of working disability during last 12 months before enrollment into the study was documented. After enrollment, participants' duration of working disability was documented for last 6 months after previous documentation. |
| Secondary | Disease Activity Score Based on 28-Joints Count (DAS28) | Baseline, Week 2, 6, 12, 26, 38, 52 | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient global assessment of disease activity (recorded on a VAS of 0 mm \[very good\] to 100 mm \[very bad\]). Total score range: 0 to 10, higher score indicated more disease activity. DAS28 less than (\<) 2.6 = remission, DAS28 less than or equal to (\<=) 3.2 = low disease activity, DAS28 greater than or equal to (\>=) 3.2 to \<=5.1 = moderate disease activity, DAS28 greater than (\>) 5.1 = high disease activity. |
| Secondary | Swollen Joints Count (SJC) | Baseline, Week 2, 6, 12, 26, 38, 52 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 | Week 26 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 | Week 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of rheumatoid arthritis, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Baseline, Week 26, Week 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | mm | MEAN |
| SECONDARY | Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Baseline, Week 26, Week 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | units on a scale | MEAN |
| SECONDARY | Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | Baseline, Week 26, Week 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | percentage of impairment | MEAN |
| SECONDARY | Healthcare Resource Utilization | Baseline, Week 26, Week 52 | Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points. | events | MEAN |
| SECONDARY | Duration of Healthcare Resources Utilization | Baseline, Week 26, Week 52 | Effectiveness population. Here 'N' (number of participants analyzed) = overall participants evaluable for any event for this measure and 'n'= participants evaluable for specified event at specified time points. | days | MEDIAN |
| SECONDARY | Duration of Working Disability | Baseline, Week 26, Week 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | days | MEDIAN |
| SECONDARY | Disease Activity Score Based on 28-Joints Count (DAS28) | Baseline, Week 2, 6, 12, 26, 38, 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | units on a scale | MEAN |
| SECONDARY | Swollen Joints Count (SJC) | Baseline, Week 2, 6, 12, 26, 38, 52 | Effectiveness population included all participants \>= 18 years of age, confirmed diagnosis of RA, who had not received treatment with etanercept previously and who had post baseline documentations. Here 'N' (number of participants analyzed) = participants evaluable for this measure and 'n' = participants evaluable at specified time points. | joints | MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group167
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 26 | Etanercept | 36.4 | 95% Confidence Interval 34.8 to 37.9 | percentage of participants | |
| Percentage of Participants Achieving Functional Remission Determined by Hannover Functional Ability Questionnaire (FFbH) at Week 52 | Etanercept | 41.5 | 95% Confidence Interval 39.7 to 43.2 | percentage of participants | |
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Etanercept | Baseline (n = 4718) | 53.1 | Standard Deviation 21.3 | mm |
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Etanercept | Week 26 (n = 3637) | 66.5 | Standard Deviation 20.7 | mm |
| Euro Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) | Etanercept | Week 52 (n = 3036) | 70.0 | Standard Deviation 20.5 | mm |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Etanercept | Baseline (n = 4718) | 0.579 | Standard Deviation 0.302 | units on a scale |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Etanercept | Week 26 (n = 3637) | 0.748 | Standard Deviation 0.244 | units on a scale |
| Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO) | Etanercept | Week 52 (n = 3036) | 0.782 | Standard Deviation 0.227 | units on a scale |
| Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | Etanercept | Baseline: Work Time Missed (n = 1295) | 22.5 | Standard Deviation 37.0 | percentage of impairment |
| Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP) | Etanercept | Baseline: Impairment While Working (n = 1534) | 49.5 | Standard Deviation 27.1 | percentage of impairment |
1 to 10 of 167Source ClinicalTrials.gov
See all 167 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 4,945 | |
| Overall Study | COMPLETED | Etanercept | 3,191 | |
| Overall Study | NOT COMPLETED | Etanercept | 1,754 |
Source ClinicalTrials.gov
Adverse events1,329
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Etanercept | 9 | 4,871 | |
| other | Eosinophilia | Blood and lymphatic system disorders | Etanercept | 1 | 4,871 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Etanercept | 2 | 4,871 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Etanercept | 2 | 4,871 | |
| other | Leukopenia | Blood and lymphatic system disorders | Etanercept | 8 | 4,871 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Etanercept | 6 | 4,871 | |
| other | Pancytopenia | Blood and lymphatic system disorders | Etanercept | 1 | 4,871 | |
| other | Spontaneous haematoma | Blood and lymphatic system disorders | Etanercept | 1 | 4,871 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Etanercept | 8 | 4,871 | |
| other | Angina pectoris | Cardiac disorders | Etanercept | 3 | 4,871 |
1 to 10 of 1,329Source ClinicalTrials.gov
See all 1,329 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, other adverse events | Etanercept | 1,921 | 4,871 |
| Total, serious adverse events | Etanercept | 649 | 4,871 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29843776 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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