Trial · NCT02404350
Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
NCT02404350, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-06-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis. Trials, record NCT02404350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02404350
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis
- NCT number
- NCT02404350
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 997 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Psoriatic Arthritis
- Interventions
- Secukinumab
- First posted
- 2015-03-31
- Last updated
- 2020-04-20
- Other registries' IDs
- eudract:2015-000050-38
- Results first posted
- 2019-06-28
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 Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Week 16 | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)). |
| Secondary | Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Baseline, Week 24 | PsA modified vdH-mTSS scoring method was used to assess bone erosion \& joint space narrowing (JSN) in hands \& feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands \& feet combined) ranges from 0 to 528, where higher scores indicate more articular damage |
| Secondary | Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response | Week 16 | The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response. |
| Secondary | Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response | 16 weeks | The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 90 (PASI90) response. |
| Secondary | Count and Percentage of Patients Achieving an ACR50 Response | 16 weeks | ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels. |
| Secondary | Change From Baseline in HAQ-DI© Score | 16 weeks | The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline. |
| Secondary | Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP)) | 16 weeks | The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline. Scores range from 0 (no difficulty) to 3 (unable to do) |
| Secondary | Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline | 16 weeks | The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline |
| Secondary | Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline | 16 weeks | The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline |
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 Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Week 16 | The analysis was performed in Full Analysis Set (FAS) population defined as all randomized participants assigned to study treatment. Following the intent-to-treat principle, participants were analyzed according to treatment assigned at randomization by actual anti-Tumor Necrosis Factor (TNF) status. Missing responses were imputed as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Baseline, Week 24 | The analysis was performed in FAS population with a measurement that could be evaluated. Participants in placebo group, rescued at Week 16 were also extrapolated (i.e. treated as missing at Week 24). | Mean Sharp Score | MEAN |
| SECONDARY | Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response | Week 16 | Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response | 16 weeks | Psoriasis subset: The psoriasis subset included all FAS patients who had ≥ 3% of the BSA affected by psoriatic skin involvement at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count and Percentage of Patients Achieving an ACR50 Response | 16 weeks | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in HAQ-DI© Score | 16 weeks | Full Analysis Set (FAS) | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP)) | 16 weeks | Full Analysis Set (FAS) | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline | 16 weeks | Enthesitis subset: The enthesitis subset included all FAS patients who had enthesitis at baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline | 16 weeks | Dactylitis subset: The dactylitis subset included all FAS patients who had dactylitis at baseline. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group40
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 Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Secukinumab 150 mg Without Load | 59.5 | percentage of participants | ||
| Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Secukinumab 150 mg With Load | 55.5 | percentage of participants | ||
| Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Secukinumab 300 mg With Load | 62.6 | percentage of participants | ||
| Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 | Placebo | 27.4 | percentage of participants | ||
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Secukinumab 150 mg Without Load | baseline | 15.25 | Standard Deviation 37.098 | Mean Sharp Score |
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Secukinumab 150 mg With Load | baseline | 13.50 | Standard Deviation 25.636 | Mean Sharp Score |
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Secukinumab 300 mg With Load | baseline | 12.90 | Standard Deviation 23.781 | Mean Sharp Score |
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Placebo | baseline | 14.95 | Standard Deviation 38.236 | Mean Sharp Score |
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Secukinumab 150 mg Without Load | change | -0.10 | Standard Deviation 2.872 | Mean Sharp Score |
| Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS)) | Secukinumab 150 mg With Load | change | 0.13 | Standard Deviation 1.222 | Mean Sharp Score |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Secukinumab 150 mg Without Load | 222 | |
| Overall Study | STARTED | Secukinumab 150 mg With Load | 220 | |
| Overall Study | STARTED | Secukinumab 300 mg With Load | 222 | |
| Overall Study | STARTED | Placebo | 332 | |
| Overall Study | COMPLETED | Secukinumab 150 mg Without Load | 207 | |
| Overall Study | COMPLETED | Secukinumab 150 mg With Load | 214 | |
| Overall Study | COMPLETED | Secukinumab 300 mg With Load | 216 | |
| Overall Study | COMPLETED | Placebo | 295 | |
| Overall Study | NOT COMPLETED | Secukinumab 150 mg Without Load | 15 | |
| Overall Study | NOT COMPLETED | Secukinumab 150 mg With Load | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events350
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 | Secukinumab 150 mg Without Load | 1 | 222 | |
| other | Leukopenia | Blood and lymphatic system disorders | Secukinumab 150 mg With Load | 1 | 220 | |
| other | Leukopenia | Blood and lymphatic system disorders | Secukinumab 300 mg With Load | 6 | 222 | |
| other | Leukopenia | Blood and lymphatic system disorders | Secukinumab Total | 11 | 822 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 1 | 332 | |
| other | Diarrhoea | Gastrointestinal disorders | Secukinumab 150 mg Without Load | 7 | 222 | |
| other | Diarrhoea | Gastrointestinal disorders | Secukinumab 150 mg With Load | 4 | 220 | |
| other | Diarrhoea | Gastrointestinal disorders | Secukinumab 300 mg With Load | 9 | 222 | |
| other | Diarrhoea | Gastrointestinal disorders | Secukinumab Total | 21 | 822 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 22 | 332 |
1 to 10 of 350Source ClinicalTrials.gov
See all 350 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Secukinumab 150 mg Without Load | 0 | 222 |
| Total, all-cause mortality | Secukinumab 150 mg With Load | 0 | 220 |
| Total, all-cause mortality | Secukinumab 300 mg With Load | 0 | 222 |
| Total, all-cause mortality | Secukinumab Total | 0 | 822 |
| Total, all-cause mortality | Placebo | 0 | 332 |
| Total, other adverse events | Secukinumab 150 mg Without Load | 95 | 222 |
| Total, other adverse events | Secukinumab 150 mg With Load | 82 | 220 |
| Total, other adverse events | Secukinumab 300 mg With Load | 83 | 222 |
| Total, other adverse events | Secukinumab Total | 275 | 822 |
| Total, other adverse events | Placebo | 127 | 332 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
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/NCT02404350
GET https://conductscience.org/api/trials/v1/NCT02404350/results?page=2