Trial · NCT03259074
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT03259074, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2023-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar). Trials, record NCT03259074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03259074
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
- NCT number
- NCT03259074
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 859 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Ankylosing Spondylitis
- Interventions
- Placebo, GP2017 (adalimumab biosimilar), AIN457 150 mg
- First posted
- 2017-08-23
- Last updated
- 2023-08-21
- Results first posted
- 2023-03-09
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | Baseline and at Week 104 | Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5. |
| Secondary | Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | Baseline and at Week 104 | Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104. The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. |
| Secondary | Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | Baseline and at Week 104 | Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as \>= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score \< 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC). |
| Secondary | Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | Baseline and at Week 104 | Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation. |
| Secondary | Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) | Baseline and at Week 104 | Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation. |
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) | Week 104 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS 20 response is defined as an improvement of ≥20% and ≥1 unit on a scale of 10 in at least three of the four main domains and no worsening of ≥20% and ≥1 unit on a scale of 10 in the remaining domain. A higher score on the VAS signifies higher severity. |
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) | Week 104 | Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the VAS signifies higher severity. |
| Secondary | Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) | Week 104 | The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10. |
| Secondary | Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) | Week 104 | The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were \< 1.3 between inactive disease and moderate disease activity, \< 2.1 between moderate disease activity and high disease activity, and \> 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change ≥ 1.1 unit for "minimal clinically important improvement" and a change ≥ 2.0 units for "major improvement" (Machado 2011). |
Source ClinicalTrials.gov
Outcomes9
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 no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | Baseline and at Week 104 | Full analysis set | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | Baseline and at Week 104 | Full analysis set | mSASSS scores | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | Baseline and at Week 104 | Syndesmophyte subset only included participants who had a syndesmophyte at baseline as measured on the mSASSS scale. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | Baseline and at Week 104 | MRI subset only included participants who had an MRI performed at selected centers | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) | Baseline and at Week 104 | MRI subset only included participants who had an MRI performed at selected centers | Berlin mod. of ASspiMRI-a edema scores | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) | Week 104 | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) | Week 104 | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) | Week 104 | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Percentage participants | NUMBER |
| SECONDARY | Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) | Week 104 | Full analysis set for the population to be analyzed in this secondary outcome: AIN457 150 mg and AIN457 300 mg arms. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group23
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 no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | AIN457 150 mg/Placebo | 66.1 | Percentage of participants | ||
| Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | AIN457 300 mg | 66.9 | Percentage of participants | ||
| Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | GP2017 40mg | 65.6 | Percentage of participants | ||
| Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | AIN457 150 mg/Placebo | 0.54 | Standard Error 0.175 | mSASSS scores | |
| Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | AIN457 300 mg | 0.55 | Standard Error 0.180 | mSASSS scores | |
| Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | GP2017 40mg | 0.72 | Standard Error 0.177 | mSASSS scores | |
| Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | AIN457 150 mg/Placebo | 56.9 | Percentage of participants | ||
| Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | AIN457 300 mg | 53.8 | Percentage of participants | ||
| Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | GP2017 40mg | 53.3 | Percentage of participants | ||
| Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | AIN457 150 mg/Placebo | -1.527 | Standard Error 0.1057 | scores on a scale |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 150 mg/Placebo | 287 | |
| Overall Study | STARTED | AIN457 300 mg | 286 | |
| Overall Study | STARTED | GP2017 40mg | 286 | |
| Overall Study | COMPLETED | AIN457 150 mg/Placebo | 254 | |
| Overall Study | COMPLETED | AIN457 300 mg | 237 | |
| Overall Study | COMPLETED | GP2017 40mg | 243 | |
| Overall Study | NOT COMPLETED | AIN457 150 mg/Placebo | 33 | |
| Overall Study | NOT COMPLETED | AIN457 300 mg | 49 | |
| Overall Study | NOT COMPLETED | GP2017 40mg | 43 |
Source ClinicalTrials.gov
Adverse events300
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 | Diarrhoea | Gastrointestinal disorders | AIN457 150 mg/Placebo | 20 | 286 | |
| other | Diarrhoea | Gastrointestinal disorders | AIN457 300 mg | 22 | 285 | |
| other | Diarrhoea | Gastrointestinal disorders | GP2017 40 mg | 11 | 285 | |
| other | Nasopharyngitis | Infections and infestations | AIN457 150 mg/Placebo | 47 | 286 | |
| other | Nasopharyngitis | Infections and infestations | AIN457 300 mg | 40 | 285 | |
| other | Nasopharyngitis | Infections and infestations | GP2017 40 mg | 44 | 285 | |
| other | Upper respiratory tract infection | Infections and infestations | AIN457 150 mg/Placebo | 17 | 286 | |
| other | Upper respiratory tract infection | Infections and infestations | AIN457 300 mg | 25 | 285 | |
| other | Upper respiratory tract infection | Infections and infestations | GP2017 40 mg | 18 | 285 | |
| other | Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | AIN457 150 mg/Placebo | 11 | 286 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 150 mg/Placebo | 1 | 286 |
| Total, all-cause mortality | AIN457 300 mg | 1 | 285 |
| Total, all-cause mortality | GP2017 40 mg | 3 | 285 |
| Total, other adverse events | AIN457 150 mg/Placebo | 106 | 286 |
| Total, other adverse events | AIN457 300 mg | 107 | 285 |
| Total, other adverse events | GP2017 40 mg | 99 | 285 |
| Total, serious adverse events | AIN457 150 mg/Placebo | 40 | 286 |
| Total, serious adverse events | AIN457 300 mg | 29 | 285 |
| Total, serious adverse events | GP2017 40 mg | 32 | 285 |
Source ClinicalTrials.gov
Papers2
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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