Trial · NCT04507763
Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis
NCT04507763, Completed, Pfizer; results first posted 2021-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis. Trials, record NCT04507763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04507763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis
- NCT number
- NCT04507763
- Status
- Completed
- Enrollment
- 763 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ankylosing Spondylitis
- Interventions
- Etanercept
- First posted
- 2020-08-11
- Last updated
- 2021-10-28
- Results first posted
- 2021-10-28
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | BASFI is a set of 10 questions to determine degree of functional limitation in participants with AS. Participants answered each 10 questions on a scale of 0 (no functional impairment) to 10 (maximal impairment). BASFI total score was calculated as mean of scores from 10 questions. BASFI total score ranged from 0 (no functional impairment) to 10 (maximal impairment), where higher scores meant worse condition. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in less than or equal to (\<=) 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and greater than (\>) 10 years after diagnosis with AS. |
| Primary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | BASDAI is a set of 6 questions to determine disease activity in participant with AS. 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. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. Early referral was considered when participants were referred to management of AS in \<= 1 year after diagnosis with AS. Participants with delayed referral to management of AS were divided into 3 groups: 1.1 to 5 years, 5.1 to 10 years and \>10 years after diagnosis with AS. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. | Units on a scale | MEAN |
| PRIMARY | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Baseline, Month 12 [from the data retrieved and observed in 2 months of this study] | Analysis population included all participants whose data were included in the study for retrospective observation. In this outcome measure, participants were grouped on the basis of early and delayed referral to management of AS with etanercept treatment. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Early Referral (<=1 Year) | Baseline | 7.75 | Standard Deviation 1.11 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Baseline | 7.74 | Standard Deviation 1.11 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Baseline | 7.72 | Standard Deviation 1.15 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (>10 Years) | Baseline | 7.78 | Standard Deviation 1.13 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Early Referral (<=1 Year) | Change from baseline at month 12 | -6.21 | Standard Deviation 1.557 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Change from baseline at month 12 | -5.44 | Standard Deviation 1.510 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (5.1 to 10 Years) | Change from baseline at month 12 | -4.14 | Standard Deviation 1.697 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Month 12 | Etanercept: Participants With Delayed Referral (>10 Years) | Change from baseline at month 12 | -4.04 | Standard Deviation 1.631 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Etanercept: Participants With Early Referral (<=1 Year) | Baseline | 8.32 | Standard Deviation 0.88 | Units on a scale |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score at Month 12 | Etanercept: Participants With Delayed Referral (1.1 to 5 Years) | Baseline | 8.36 | Standard Deviation 0.47 | Units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04507763
GET https://conductscience.org/api/trials/v1/NCT04507763/registered