A Phase 3 interventional study of Placebo and GP2017 (adalimumab biosimilar) in Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals. Completed at 171 sites in 29 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 20 studies testing secukinumab in Spondylitis, Ankylosing — 3 open to participants now, 4 under way, none of them phase 3. secukinumab · Spondylitis, Ankylosing.
Among the 20 studies testing secukinumab in Spondylitis, Ankylosing, this one has the largest enrollment, is one of 2 that started in 2017, is one of 11 in phase 3, and was the 13th registered.
533 studies on the registry are indexed under Spondylitis, Ankylosing; 99 are open to participants now.
Browse Spondylitis, Ankylosing studies →3 of the 20 studies testing secukinumab in Spondylitis, Ankylosing are open now, in 2 countries. Recruiting first, the newest first:
NYU Langone Health · Sites in United States
Ages 18+
Tongji Hospital · Sites in China
Ages 18–80
The Affiliated Hospital Of Guizhou Medical University · Sites in China
Ages 18+
By country, each count listing its studies:
secukinumab: first FDA approval 2015 (COSENTYX), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 63 Spondylitis, Ankylosing studies recruiting now, 25 (40%) set no upper age limit and 32 (51%) stop at 75 or younger; 10 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 859 is above the median of 88 across 303 interventional studies indexed under Spondylitis, Ankylosing.
Median enrollment 223 across the 20 interventional studies. Of the 15 that completed or were terminated, 15 (100%) have results posted.
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15 of 20 have an industry lead sponsor. The 6 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
21 studies in Spondylitis, Ankylosing by Novartis: 2 open now, 2 under way, none of them phase 3. Of 19 finished, 17 (89%) have results posted.
Among the 21 studies in Spondylitis, Ankylosing by Novartis, this one has the largest enrollment of the 17 interventional ones that give a count, is one of 3 that started in 2017, is one of 11 in phase 3, and was the 15th registered.
Novartis’s Spondylitis, Ankylosing studies by the year they started, since 2009.
1 of the studies testing secukinumab in Spondylitis, Ankylosing that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06833112The Affiliated Hospital Of Guizhou Medical UniversityInterleukin-17 (IL-17) Inhibitor in Combination With Tumor Necrosis Factor α (TNFα )Inhibitor for the Treatment of Ankylosing Spondylitis | 2027-08 |
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Among the 20 studies testing secukinumab in Spondylitis, Ankylosing, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Novartis’s 21 in Spondylitis, Ankylosing:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120).
Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).
A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Biological: Placebo · Biological: AIN457 150 mg
AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Biological: AIN457 150 mg
GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102
Biological: GP2017 (adalimumab biosimilar)
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
40 mg in pre-filled syringes was administered subcutaneously
Also known as: adalimumab biosimilar
150 mg in pre-filled syringes was administered subcutaneously
Also known as: secukinumab
Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
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.
Time frame: Baseline and at Week 104
Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)
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.
Time frame: Baseline and at Week 104
Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)
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).
Time frame: Baseline and at Week 104
Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)
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.
Time frame: Baseline and at Week 104
Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)
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.
Time frame: Baseline and at Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)
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.
Time frame: Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)
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.
Time frame: Week 104
Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)
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.
Time frame: Week 104
Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)
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).
Time frame: Week 104
| Milestone | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Started | 287 | 286 | 286 |
| Completed | 254 | 237 | 243 |
| Not completed | 33 | 49 | 43 |
| Withdrew: Adverse event | 9 | 12 | 8 |
| Withdrew: Death | 1 | 1 | 3 |
| Withdrew: Lost to follow-up | 2 | 4 | 3 |
| Withdrew: New therapy for study indication | 1 | 2 | 2 |
| Withdrew: Physician decision | 4 | 12 | 10 |
| Withdrew: Pregnancy | 1 | 1 | 0 |
| Withdrew: Progressive disease | 1 | 0 | 0 |
| Withdrew: Protocol deviation | 1 | 1 | 3 |
| Withdrew: Subject/guardian decision | 13 | 16 | 14 |
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.
| Percentage of participants | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) | 66.1 | 66.9 | 65.6 |
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.
| mSASSS scores | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) | 0.54 ± 0.175 | 0.55 ± 0.180 | 0.72 ± 0.177 |
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).
| Percentage of participants | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) | 56.9 | 53.8 | 53.3 |
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.
| scores on a scale | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) | -1.527 ± 0.1057 | -1.378 ± 0.1097 | -1.710 ± 0.1087 |
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.
| Berlin mod. of ASspiMRI-a edema scores | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg |
|---|---|---|---|
| Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) | -1.224 ± 0.2306 | -1.683 ± 0.2373 | -2.101 ± 0.2378 |
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.
| Percentage of participants | AIN457 150 mg/Placebo | AIN457 300 mg |
|---|---|---|
| Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) | 83.1 (77.8 to 87.4) | 82.9 (77.3 to 87.4) |
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.
| Percentage of participants | AIN457 150 mg/Placebo | AIN457 300 mg |
|---|---|---|
| Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) | 69.9 (63.7 to 75.4) | 73.5 (67.3 to 78.9) |
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.
| Percentage participants | AIN457 150 mg/Placebo | AIN457 300 mg |
|---|---|---|
| Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) | 31.5 (25.9 to 37.7) | 30.2 (24.5 to 36.6) |
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).
| Percentage of participants | AIN457 150 mg/Placebo | AIN457 300 mg |
|---|---|---|
| Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) | 31.1 (25.5 to 37.4) | 31.7 (25.7 to 38.3) |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 84 days up to a maximum of 900 days for AIN 457 and 939 days for GP2017.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AIN457 150 mg/Placebo | 1/286 (0.3%) | 40/286 (14%) | 106/286 (37.1%) |
| AIN457 300 mg | 1/285 (0.4%) | 29/285 (10.2%) | 107/285 (37.5%) |
| GP2017 40 mg | 3/285 (1.1%) | 32/285 (11.2%) | 99/285 (34.7%) |
| Event | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40 mg |
|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 2/286 | 3/285 | 0/285 |
| ColitisGastrointestinal disorders | 3/286 | 0/285 | 0/285 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/286 | 1/285 | 1/285 |
| Pancreatitis acuteGastrointestinal disorders | 1/286 | 0/285 | 2/285 |
| PneumoniaInfections and infestations | 0/286 | 1/285 | 2/285 |
| PyelonephritisInfections and infestations | 0/286 | 2/285 | 0/285 |
| Urinary tract infectionInfections and infestations | 0/286 | 0/285 | 2/285 |
| IridocyclitisEye disorders | 2/286 | 1/285 | 0/285 |
| Cardiac failureCardiac disorders | 0/286 | 0/285 | 1/285 |
| Retinal detachmentEye disorders | 0/286 | 0/285 | 1/285 |
| Event | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40 mg |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 47/286 | 40/285 | 44/285 |
| Upper respiratory tract infectionInfections and infestations | 17/286 | 25/285 | 18/285 |
| DiarrhoeaGastrointestinal disorders | 20/286 | 22/285 | 11/285 |
| Ankylosing spondylitisMusculoskeletal and connective tissue disorders | 11/286 | 17/285 | 12/285 |
| HeadacheNervous system disorders | 16/286 | 17/285 | 17/285 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 16/286 | 13/285 | 12/285 |
| HypertensionVascular disorders | 11/286 | 11/285 | 15/285 |
| Age, Continuous(years) | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg | Total |
|---|---|---|---|---|
| Mean | 42.1 ± 11.99 | 42.2 ± 12.47 | 41.9 ± 12.68 | 42.1 ± 12.37 |
| Sex: Female, Male(Participants) | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg | Total |
|---|---|---|---|---|
| Female | 57 | 63 | 65 | 185 |
| Male | 230 | 223 | 221 | 674 |
| Race/Ethnicity, Customized(Participants) | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg | Total |
|---|---|---|---|---|
| White | 225 | 227 | 228 | 680 |
| Black or African American | 1 | 2 | 0 | 3 |
| Asian | 40 | 39 | 50 | 129 |
| American Indian or Alaska Native | 19 | 15 | 7 | 41 |
| Other | 1 | 0 | 0 | 1 |
| Multiple | 1 | 3 | 1 | 5 |
| Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) scores(score on a scale) | AIN457 150 mg/Placebo | AIN457 300 mg | GP2017 40mg | Total |
|---|---|---|---|---|
| Mean | 17.602 ± 21.3286 | 16.527 ± 20.8153 | 15.695 ± 19.4955 | 16.609 ± 20.5506 |
Showing the first 100 of 171 sites across 29 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Ran from Nov 2017 to primary completion in Nov 2021, 47 months.
Results were first posted in Mar 2023, 1 year 3 months after primary completion. A results delay was requested in Jul 2022.
Of 38 industry-sponsored phase 3 interventional studies under Spondylitis, Ankylosing, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 28. This study's 47 months is above that.
Counting every sponsor, half of 40 studies reached it within 21 months; a quarter within 15 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Secukinumab