Trial · NCT04507776
Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel
NCT04507776, Completed, Pfizer; results first posted 2021-10-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel. Trials, record NCT04507776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04507776
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate The Efficacy And Long-Term Adherence Of Spondyloarthropathies(SpA) Patients On Enbrel
- NCT number
- NCT04507776
- Status
- Completed
- Enrollment
- 763 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Spondyloarthrosis
- Interventions
- Etanercept
- First posted
- 2020-08-11
- Last updated
- 2021-10-04
- Results first posted
- 2021-10-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With 7 Years Adherence to Etanercept | 7 years [from the data retrieved and observed in 1 month of this study] | In this outcome measure, percentage of participants who continued etanercept treatment and adhered to the treatment for 7 years were reported. |
| Other | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared absolute BASDAI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
| Other | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with SpA. Participants answered each 6 questions on a scale of 0 (no problem) to 10 (the worst problem). The BASDAI score is calculated by computing the mean of questions 5 and 6 and adding it to the sum of questions (Q) 1-4. This score is then divided by 5. BASDAI score = (Q1 + Q2 + Q3+ Q4+ \[Q5 + Q6/2\])/5. BASDAI score ranges from 0 (best) to 10 (worst), where higher scores meant worse condition. This outcome measure compared change from baseline in BASDAI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
| Other | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared absolute BASFI score between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence, last visit was Year 7. |
| Other | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with SpA. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI score was calculated as mean of scores from 10 questions. BASFI score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. This outcome measure compared change from baseline in BASFI score at last visit between the participants who were adherent and not adherent to treatment. Comparison was done for 1 and 7 year adherence. For Year 1 adherence, last visit was Year 1 (Month 12). For Year 7 adherence last visit was Year 7. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With 7 Years Adherence to Etanercept | 7 years [from the data retrieved and observed in 1 month of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Absolute Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points. | Units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in BASFI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Year 1 adherence: Baseline (pre-treatment), Year 1; Year 7 adherence: Baseline (pre-treatment), Year 7 [from the data retrieved and observed in 1 month of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. Here, number analyzed signifies the number of participants evaluable at specific time points. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With 7 Years Adherence to Etanercept | Etanercept | 60.6 | Percentage of participants | ||
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Adherent to Treatment | Year 1 Adherence: Baseline | 8.0579 | Standard Deviation 0.83161 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Not Adherent to Treatment | Year 1 Adherence: Baseline | 8.0238 | Standard Deviation 0.81532 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 1.3310 | Standard Deviation 1.74750 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Not Adherent to Treatment | Year 1 Adherence: Year 1 (Month 12) | 3.8261 | Standard Deviation 1.71364 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Adherent to Treatment | Year 7 Adherence: Baseline | 8.4813 | Standard Deviation 0.51830 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Not Adherent to Treatment | Year 7 Adherence: Baseline | 8.0000 | Standard Deviation 0.88561 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Adherent to Treatment | Year 7 Adherence: Year 7 | 1.3256 | Standard Deviation 1.49022 | Units on a scale |
| Absolute Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Baseline and Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Not Adherent to Treatment | Year 7 Adherence: Year 7 | 1.1040 | Standard Deviation 1.68353 | Units on a scale |
| Change From Baseline in BASDAI Score at Last Visit: Participants Adherent and Not Adherent to Treatment | Etanercept: Participants Adherent to Treatment | Year 1 Adherence: Change at Year 1 (Month 12) | 6.7269 | Standard Deviation 1.90446 | Units on a scale |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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 | 763 | |
| Overall Study | COMPLETED | Etanercept | 562 | |
| Overall Study | NOT COMPLETED | Etanercept | 201 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | 0 | 0 |
| Total, other adverse events | Etanercept | 0 | 0 |
| Total, serious adverse events | Etanercept | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36178583 | 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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04507776
GET https://conductscience.org/api/trials/v1/NCT04507776/results?page=2