Trial · NCT01583374
Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
NCT01583374, Phase 3, Completed, Amgen; results first posted 2015-03-17
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ConductScience Library. Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis. Trials, record NCT01583374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01583374
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Apremilast to Treat Subjects With Active Ankylosing Spondylitis
- NCT number
- NCT01583374
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 490 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Ankylosing Spondyloarthritis
- Interventions
- Apremilast tablet 20 mg, Apremilast tablet 30 mg BID, Placebo
- First posted
- 2012-04-24
- Last updated
- 2020-05-12
- Other registries' IDs
- eudract:2011-001555-37
- Results first posted
- 2015-03-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 | Baseline and Week 16 | ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain" 3. Function (Bath AS Functional Index \[BASFI\] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability 4. Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit) |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | Baseline and Week 24 | The BASFI is a composite score based on a self-administered survey of 10 questions using a 0 to 10 unit numerical rating scale (NRS) that assesses the degree of mobility and functional ability. The survey consists of 8 questions regarding function in AS and the last 2 reflect the ability to manage everyday life. The patient marks a box with an X on a 0 to 10 unit NRS for 10 questions; the left-hand box of 0 = easy; the right-hand box = impossible. The resulting 0 to 100 score is divided by 10 to give a final 0 to 10 BASFI score. The overall score is the mean of the 10 items and ranges from 0 to 10. A higher score correlates to reduced functional ability. |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Baseline and Week 24 | The BASDAI is a composite score based on a participant self-administered survey of six questions measured using a 0 to 10 unit numerical rating scale (NRS) that assessed the participants' five major symptoms of AS: 1) fatigue; 2) spinal pain; 3) peripheral joint pain/swelling; 4) areas of localized tenderness; 5a) morning stiffness severity upon wakening; 5b) morning stiffness duration upon wakening. The participant was asked to mark the box with an X on a 0 to 10 unit NRS for each of the 6 questions. To give each of the five symptoms equal weighting, the mean of the two scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI score. A BASDAI score of 4 or greater was considered to be indicative of active AS disease. |
| Secondary | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24 | Baseline and Week 24 | ASAS 20 was defined as achieving an improvement from baseline of ≥ 20% and ≥ 1 unit in at least 3 of 4 ASAS domains on a scale of 0 to 10 units and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining ASAS domain on a scale of 0 to 10 units. The 4 ASAS domains are: 1. Patient Global Assessment of Disease (0 - 10 unit Numerical Rating Scale \[NRS\]); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = not active and the right-hand box = very active 2. Total Back Pain (0 to 10 unit NRS); participant marks a box with an X on a 0 - 10 unit NRS; the left-hand box of 0 = "no pain" and the right-hand box = "most severe pain" 3. Function (Bath AS Functional Index \[BASFI\] NRS 0 - 10 unit); participant provides a self-administered survey of 10 questions assessing for degree of mobility and functional ability 4. Inflammation domain is determined by the mean of 2 Bath AS Disease Activity Index NRS Questions #5 and #6 for morning stiffness) (0 - 10 unit) |
| Secondary | Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24 | Baseline and Week 24 | The ASQoL is a validated disease specific patient reported outcomes instrument to assess the impact of ankylosing spondylitis on the quality of life of individuals with emphasis on the ability of the person to fulfill his or her needs. It consisted of 18 items requesting a yes (score=1) or no (score=0) response to questions related to the impact of pain on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. The summary score ranges 0-18 with higher scores indicating worse quality of life. |
| Secondary | Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24 | Baseline and Week 24 | The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) was a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores (based on US general population with mean of 50 and standard deviation of 10) were used in analyses. Higher scores indicate a higher level of functioning. The PCS encompasses physical functioning, role-physical, and bodily pain, as well as general health and vitality. A positive change from baseline score indicates an improvement |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24 | Baseline and Week 24 | The BASMI-Linear was designed to assess axial status (ie, cervical, dorsal and lumbar spine, hips, and pelvic soft tissue) and to define clinically significant changes in spinal movement. Five dimensions of movement (lateral lumbar flexion, tragus to wall, forward lumbar flexion, maximal intermalleolar distance, and cervical rotation) were measured and normalized on 0 to 10 unit NRS. The average of these scores was the total BASMI score, ranging from 0-10 with higher values indicating more severe limitation in spinal mobility. |
| Secondary | Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260 | Baseline to Week 104 and 260 | The Modified Stoke Ankylosing Spondylitis Spine Score is a scoring method used to determine the amount or degree of ankylosing spondylitis disease that is in the spine based on x-ray radiographs of the spine. The m-SASSS scores 0-3. 0 = No abnormality, 1 = Erosion, Sclerosis or Squaring, 2 = Syndesmophyte, 3 = Total bony Bridging at each Site. An increase in the m-SASSS indicated a worsening of AS disease. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase | From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm. | A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period | Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks | A TEAE was an adverse event (AE) with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. A serious AE = results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; or constitutes an important medical event. The severity of AEs was assessed based on the following scale: Mild = asymptomatic or mild symptoms, clinical or diagnostic observations only; Moderate = symptoms cause moderate discomfort; Severe = symptoms causing severe pain discomfort. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 | Baseline and Week 16 | The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | Baseline and Week 24 | The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Baseline and Week 24 | The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24 | Baseline and Week 24 | The mITT population included participants who were randomized and received at least one dose of investigation product (IP). Participants who discontinued early due to lack of efficacy were counted as nonresponders, and last observation carried forward (LOCF) imputation was used for participants who discontinued for other reasons. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in the Ankylosing Spondylitis Quality of Life (ASQoL) Summary Score at Week 24 | Baseline and Week 24 | The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Physical Component Summary Score (PCS) of Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) at Week 24 | Baseline and Week 24 | The mITT included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Bath Ankylosing Spondylitis Metrology Index-Linear (BASMI-Linear) at Week 24 | Baseline and Week 24 | The mITT population included those who were randomized and received at least one dose of IP. Missing data were imputed as baseline carried forward for participants who escaped early or discontinued early (prior to Week 24) due to lack of efficacy and LOCF for other early discontinuations | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Radiographic Score Using the Modified Stoke Ankylosing Spondylitis Spine Score (m-SASSS) at Week 104 and Week 260 | Baseline to Week 104 and 260 | The radiograph subset analysis population included randomized participants who received at least one dose of IP and had at least a baseline radiograph available. Includes apremilast participants as treated who had a baseline and at least one post-baseline score. Missing scores were imputed using the LOCF. | Units on a Scale | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Phase | From Week 0 to Week 24; the median duration of exposure was 23.57 weeks for the placebo arm, 23.71 weeks for the apremilast 20 mg arm and 24.00 weeks for the apremilast 30 mg arm. | Safety population includes all participants who were randomized and received at least one dose of IP. Includes data through Week 16 for placebo-treated and apremilast 20 mg BID treated participants who escaped early and data up to Week 24 for all other participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period | Week 0 to week 260; overall mean duration of exposure to apremilast 20 mg and 30 mg BID was 160.96 weeks | Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 | Placebo | 36.6 | Percentage of Participants | ||
| Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 | Apremilast 20 mg | 35.0 | Percentage of Participants | ||
| Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16 | Apremilast 30 mg | 32.5 | Percentage of Participants | ||
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | Placebo | -0.94 | Standard Error 0.136 | Units on a Scale | |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | Apremilast 20 mg | -1.11 | Standard Error 0.137 | Units on a Scale | |
| Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | Apremilast 30 mg | -0.99 | Standard Error 0.138 | Units on a Scale | |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Placebo | -1.21 | Standard Error 0.136 | Units on a Scale | |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Apremilast 20 mg | -1.30 | Standard Error 0.136 | Units on a Scale | |
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | Apremilast 30 mg | -1.18 | Standard Error 0.137 | Units on a Scale | |
| Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS) Response at Week 24 | Placebo | 31.7 | Percentage of Participants |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo-controlled Phase (Week 0-24) | STARTED | Placebo | 164 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 20 mg | 163 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 30 mg | 163 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Placebo / Apremilast 30 mg Early Escape (EE) | 0 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Placebo/Apremilast 30 mg Crossover (XO) | 0 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 30 mg /Apremilast 30 mg EE | 0 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 20 mg /Apremilast 30 mg EE | 0 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 30 mg /Apremilast 30 mg Second Escape (SE) | 0 | |
| Placebo-controlled Phase (Week 0-24) | STARTED | Apremilast 20 mg/Apremilast 30 mg SE | 0 | |
| Placebo-controlled Phase (Week 0-24) | Received Treatment | Placebo | 164 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events528
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 | Iridocyclitis | Eye disorders | Placebo (Weeks 0-24) Placebo-Controlled Phase | 0 | 164 | |
| other | Iridocyclitis | Eye disorders | Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase | 1 | 163 | |
| other | Iridocyclitis | Eye disorders | Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase | 1 | 163 | |
| other | Iridocyclitis | Eye disorders | Apremilast 20 mg BID (APR Exposure Period) | 2 | 163 | |
| other | Iridocyclitis | Eye disorders | Apremilast 20/30 mg BID (APR Exposure Period) | 4 | 72 | |
| other | Iridocyclitis | Eye disorders | Apremilast 30 mg BID (APR Exposure Period) | 8 | 305 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (Weeks 0-24) Placebo-Controlled Phase | 4 | 164 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase | 3 | 163 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase | 9 | 163 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Apremilast 20 mg BID (APR Exposure Period) | 7 | 163 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Weeks 0-24) Placebo-Controlled Phase | 0 | 164 |
| Total, all-cause mortality | Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase | 0 | 163 |
| Total, all-cause mortality | Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase | 0 | 163 |
| Total, all-cause mortality | Apremilast 20 mg BID (APR Exposure Period) | 0 | 163 |
| Total, all-cause mortality | Apremilast 20/30 mg BID (APR Exposure Period) | 1 | 72 |
| Total, all-cause mortality | Apremilast 30 mg BID (APR Exposure Period) | 1 | 305 |
| Total, other adverse events | Placebo (Weeks 0-24) Placebo-Controlled Phase | 37 | 164 |
| Total, other adverse events | Apremilast 20 mg BID (Weeks 0-24) Placebo-Controlled Phase | 58 | 163 |
| Total, other adverse events | Apremilast 30 mg BID (Weeks 0-24) Placebo-Controlled Phase | 57 | 163 |
| Total, other adverse events | Apremilast 20 mg BID (APR Exposure Period) | 82 | 163 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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.
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GET https://conductscience.org/api/trials/v1/NCT01583374/results?page=2