Trial · NCT04169373
A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
NCT04169373, Phase 3, Completed, AbbVie; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis. Trials, record NCT04169373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04169373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis
- NCT number
- NCT04169373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 734 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Spondyloarthritis
- Interventions
- Upadacitinib, Placebo
- First posted
- 2019-11-19
- Last updated
- 2026-02-24
- Results first posted
- 2022-09-21
Source ClinicalTrials.gov
Registered outcomes37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14 | Baseline and Week 14 | ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration). |
| Primary | Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14 | Baseline and Week 14 | ASAS40 response was defined as improvement of ≥ 40% relative to Baseline and absolute improvement of ≥ 2 units (on a scale from 0 to 10) in ≥ 3 of the following 4 domains with no deterioration (defined as a net worsening of \> 0 units) in the potential remaining domain: * Patient's global assessment of disease activity, measured on a numeric rating scale (NRS) from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration). |
| Secondary | Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14 | Baseline and Week 14 | ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score; published ranges for disease activity states as defined by the ASDAS include Inactive disease (ASDAS \< 1.3) and very high disease (ASDAS \> 3.5). A negative change from Baseline score indicates improvement in disease activity. |
| Secondary | Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14 | Baseline and Week 14 | In the SPARCC MRI assessment of the spine, the entire spine was evaluated for active inflammation (bone marrow edema). Six discovertebral units (DVU) representing the 6 most abnormal DVUs were selected to calculate the MRI Spine SPARCC score. For each of the 6 DVUs, 3 consecutive sagittal slices were assessed in 4 quadrants to evaluate the extent of inflammation in all three dimensions. Each quadrant was scored for the presence (1) or absence (0) of edema. If edema was present in at least one quadrant of a DVU slice, it was also scored for intensity and depth of the edema representing that slice: An additional score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. Slices that included a lesion demonstrating continuous increased signal of depth ≥ 1 cm extending from the endplate were scored as an additional 1 per slice. The maximum (worst) overall score for all 6 DVUs is 108. A negative change from Baseline indicates improvement. |
| Secondary | Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14 | Baseline and Week 14 | The BASDAI assesses disease activity by asking the participant to answer 6 questions (each on an 11 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For Questions 1 to 5 (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10. Lower scores indicate less disease activity. A BASDAI 50 response is defined as improvement of 50% or more from Baseline in BASDAI score. |
| Secondary | Study 1: Percentage of Participants With an ASAS20 Response at Week 14 | Baseline and Week 14 | ASAS20 response was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 1 unit (on a scale of 0 to 10) from Baseline in at least 3 of the following 4 domains, with no deterioration (defined as a worsening of ≥ 20% and a net worsening of ≥ 1 units \[on a scale of 0 to 10\]) in the remaining domain: * Patient's global assessment of disease activity, measured on a NRS from 0 (no activity) to 10 (severe activity); * Pain, measured by the total back pain NRS from 0 (no pain) to 10 (most severe pain); * Function, measured by the BASFI which consists of 10 items assessing participants' ability to perform activities on an NRS ranging from 0 (easy) to 10 (impossible); * Inflammation, measured by the mean of the 2 morning stiffness-related BASDAI NRS scores (items 5 \[level of stiffness\] and 6 \[duration of stiffness\]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration). |
| Secondary | Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14 | Week 14 | ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Inactive Disease is defined as an ASDAS score \< 1.3. |
| Secondary | Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14 | Baseline and Week 14 | Participants assessed their total back pain during the last week on a 0 to 10 numerical rating scale (NRS), where 0 represents no pain and 10 represents most severe pain. |
| Secondary | Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14 | Baseline and Week 14 | Participants assessed the amount of back pain at night over the last week on a 0 to 10 NRS, where 0 represents no pain and 10 represents most severe pain. |
| Secondary | Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14 | Week 14 | ASDAS is a composite index to assess disease activity in Ankylosing Spondylitis. ASDAS combines the following 5 disease activity variables using a weighted formula: 1. Patient's assessment of total back pain (BASDAI Question 2; NRS score 0 \[none\] - 10 \[very severe\]) 2. Patient global assessment of disease activity (NRS score 0 \[no activity\] - 10 \[severe activity\]) 3. Peripheral pain/swelling (BASDAI Question 3; NRS score 0 \[none\] - 10 \[very severe\]) 4. Duration of morning stiffness (BASDAI Question 6; NRS score 0 \[0 hours\] - 10 \[2 or more hours\]) 5. High-sensitivity C-reactive protein (hs-CRP) in mg/L. The overall score ranges from 0 with no defined upper score. ASDAS Low Disease Activity is defined as an ASDAS score \< 2.1. |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 registered outcomesOutcomes37
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14 | Baseline and Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation (MI). | percentage of participants | NUMBER |
| PRIMARY | Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14 | Baseline and Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation. | percentage of participants | NUMBER |
| SECONDARY | Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14 | Baseline and Week 14 | Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement (MMRM) analysis including all observed data up to Week 14 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14 | Baseline and Week 14 | Full analysis set participants with available change from Baseline data | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14 | Baseline and Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation. | percentage of participants | NUMBER |
| SECONDARY | Study 1: Percentage of Participants With an ASAS20 Response at Week 14 | Baseline and Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation. | percentage of participants | NUMBER |
| SECONDARY | Study 1: Percentage of Participants With ASDAS Inactive Disease at Week 14 | Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation. | percentage of participants | NUMBER |
| SECONDARY | Study 1: Change From Baseline in Patient's Assessment of Total Back Pain at Week 14 | Baseline and Week 14 | Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Study 1: Change From Baseline in Patient's Assessment of Nocturnal Back Pain at Week 14 | Baseline and Week 14 | Full analysis set participants with at least one available change from Baseline value; a mixed-effect model repeat measurement analysis including all observed data up to Week 14 was used. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Study 1: Percentage of Participants With ASDAS Low Disease Activity at Week 14 | Week 14 | Full analysis set; participants who discontinued study drug prior to Week 14 or with missing data for reasons other than COVID-19 were counted as non-responders (non-responder imputation); Missing data due to COVID-19 infection or logistical restriction was handled by multiple imputation. | percentage of participants | NUMBER |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14 | Study 1: Placebo | 18.2 | 95% Confidence Interval 13.0 to 23.4 | percentage of participants | |
| Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14 | Study 1: Upadacitinib 15 mg | 44.5 | 95% Confidence Interval 37.8 to 51.3 | percentage of participants | |
| Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14 | Study 2: Placebo | 22.5 | 95% Confidence Interval 16.0 to 29.1 | percentage of participants | |
| Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14 | Study 2: Upadacitinib 15 mg | 44.9 | 95% Confidence Interval 37.1 to 52.7 | percentage of participants | |
| Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14 | Study 1: Placebo | -0.49 | 95% Confidence Interval -0.62 to -0.37 | score on a scale | |
| Study 1: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 14 | Study 1: Upadacitinib 15 mg | -1.52 | 95% Confidence Interval -1.64 to -1.39 | score on a scale | |
| Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14 | Study 1: Placebo | -0.04 | 95% Confidence Interval -1.14 to 1.06 | score on a scale | |
| Study 1: Change From Baseline in Magnetic Resonance Imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) Score for the Spine at Week 14 | Study 1: Upadacitinib 15 mg | -3.95 | 95% Confidence Interval -5.06 to -2.83 | score on a scale | |
| Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14 | Study 1: Placebo | 16.7 | 95% Confidence Interval 11.7 to 21.8 | percentage of participants | |
| Study 1: Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response at Week 14 | Study 1: Upadacitinib 15 mg | 43.1 | 95% Confidence Interval 36.4 to 49.8 | percentage of participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow140
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | DB Study 1: Placebo | 209 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | DB Study 1: Upadacitinib 15 mg | 211 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | DB Study 2: Placebo | 158 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | DB Study 2: Upadacitinib 15 mg | 156 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | OL Study 1: Upadacitinib 15 mg | 0 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | OL Study 2: Upadacitinib 15 mg | 0 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | RW Study 1: Off Upadacitinib - No Flare | 0 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | RW Study 2: Off Upadacitinib - No Flare | 0 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | RW Study 1: Upadacitinib 15 mg - No Flare | 0 | |
| Double Blind (DB): Week 1 - 14 or 52 | STARTED | RW Study 2: Upadacitinib 15 mg - No Flare | 0 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 participant flowAdverse events1,526
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 | LEUKOPENIA | Blood and lymphatic system disorders | DB Study 1: Placebo | 0 | 209 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | DB Study 1: Upadacitinib 15 mg | 4 | 211 | 4 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | OL Study 1: Upadacitinib 15 mg | 13 | 410 | 18 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | DB Study 2: Placebo | 2 | 158 | 3 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | DB Study 2: Upadacitinib 15 mg | 1 | 156 | 1 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | OL Study 2: Upadacitinib 15 mg | 3 | 271 | 3 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | RW Study 1: Upadacitinib 15 mg - No Flare | 0 | 3 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | RW Study 2: Upadacitinib 15 mg - No Flare | 0 | 5 | 0 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | RW Study 1: Upadacitinib 15 mg - Flare | 1 | 93 | 1 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | RW Study 2: Upadacitinib 15 mg - Flare | 3 | 52 | 5 |
1 to 10 of 1,526Source ClinicalTrials.gov
See all 1,526 adverse eventsAdverse event totals42
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Study 1: Placebo | 0 | 209 |
| Total, all-cause mortality | DB Study 1: Upadacitinib 15 mg | 0 | 211 |
| Total, all-cause mortality | OL Study 1: Upadacitinib 15 mg | 1 | 410 |
| Total, all-cause mortality | DB Study 2: Placebo | 0 | 158 |
| Total, all-cause mortality | DB Study 2: Upadacitinib 15 mg | 0 | 156 |
| Total, all-cause mortality | OL Study 2: Upadacitinib 15 mg | 0 | 271 |
| Total, all-cause mortality | RW Study 1: Upadacitinib 15 mg - No Flare | 0 | 3 |
| Total, all-cause mortality | RW Study 2: Upadacitinib 15 mg - No Flare | 0 | 5 |
| Total, all-cause mortality | RW Study 1: Upadacitinib 15 mg - Flare | 0 | 93 |
| Total, all-cause mortality | RW Study 2: Upadacitinib 15 mg - Flare | 0 | 52 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse event totalsPapers13
The papers the trial lists on ClinicalTrials.gov.
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/NCT04169373
GET https://conductscience.org/api/trials/v1/NCT04169373/registered?page=2