Trial · NCT04209205
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
NCT04209205, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-04-26
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis. Trials, record NCT04209205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04209205
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
- NCT number
- NCT04209205
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 381 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Psoriatic Arthritis
- Interventions
- AIN457 6 mg/kg i.v., Placebo, AIN457 3 mg/kg
- First posted
- 2019-12-24
- Last updated
- 2025-05-16
- Results first posted
- 2024-04-26
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Percentage of participants with active psoriatic arthritis (PsA) who achieved an American College of Rheumatology 50 (ACR50) response The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP) |
| Secondary | Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. |
| Secondary | Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5 |
| Secondary | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Change from baseline of a 90% reduction in the PASI score for patients with a \>= 3% body surface area psoriasis at baseline. Four body surface areas are evaluated (head, trunk and upper and lower limbs) for plaque, erythema, scaling and thickness. The degree of severity of each sign in each of the 4 body areas was assigned a score of 0 to 4. Scores ranged from 0 to 72 and higher scores represent worsening severity. |
| Secondary | Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | PASDAS is a composite measure developed to assess disease activity in Psoriatic arthritis. It is calculated by utilizing seven measures: Patient reported measures (excluding mental component) (SF-36-PCS), skin, peripheral joint counts (tender and swollen joint counts), dactylitis (LDI), enthesitis (LEI), acute phase response (CRP), and patient and physician global VAS scores. The typical score range is between 0 and 10. Smaller values on PASDAS indicate a better condition; a negative change from baseline indicates improvement. |
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability. |
| Secondary | Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | The SF-36 is used to measure health-related quality of life with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Range of scoring is 0 -100, with higher scores indicating better health status. |
| Secondary | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | The FACIT-Fatigue is a 13 item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Response scale ranges from 0-4 and the total score range is 0 - 52. Higher scores indicate better quality of life |
| Secondary | Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | The mNAPSI is an instrument to assess psoriatic nail involvement. Three groups of features (onycholysis and oil-drop dyshromia, pitting and crumbling) were graded on a scale from 0 to 3 for a total subscale of 0 to 9. The next 4 abnormalities (leukonychia, splinter hemorrhages, hyperkeratosis and red spots in the lunula) were graded as absent (0) or present (1) for a total subscale of 0 to 4. The total score was from 0-13 where higher scores represent worse nail disease. |
| Secondary | Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset) | Baseline up to Week 16 | Dactylitis is characterized by swelling of the entire finger or toe. The Leeds Dactylitis Index (LDI) measures the ratio of the circumference of the affected (swollen) digit. The ratio of circumference is multiplied by a tenderness score, using a modification of LDI that is a binary score (1 for tender, 0 for non-tender). The LDI requires a finger circumference gauge or a dactylometer to measure digital circumference. Scores range from 0 - 20 and lower score indicates better outcome. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set from which subset of ACR50 responders was analyzed | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set from which subset of ACR20 responders was analyzed | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set from which subset of MDA 5/7 responders was analyzed | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set from which subset of PASi90 responders was analyzed | Percentage of participants | NUMBER |
| SECONDARY | Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set with participants with valid measures at baseline and Week 16 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set with participants with valid measures at baseline and Week 16 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Short Form 36-Physical Component Summary (SF36-PCS) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set with participants with valid measures at baseline and Week 16 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set with participants with valid measures at baseline and Week 16 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Modified Nail Psoriasis Severity Index (mNAPSI) Score Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Baseline up to Week 16 | Full analysis set with participants with valid measures at baseline and Week 16 | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Complete Resolution of Dactylitis at Week 16 Using Non-responder Imputation (Dactylitis Subset) | Baseline up to Week 16 | Dactylitis subset - participants with dactylitis at baseline | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
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 American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set) | AIN457 6 mg/kg - 3 mg/kg i.v. | 31.35 | 95% Confidence Interval 24.80 to 37.90 | Percentage of participants | |
| Percentage of Participants With American College of Rheumatology 50 (ACR50) Response Comparison Between Treatment Groups Using Non-responder Imputation at Week 16 (Full Analysis Set) | Placebo to AIN457 3 mg/kg i.v. | 6.33 | 95% Confidence Interval 2.87 to 9.79 | Percentage of participants | |
| Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | AIN457 6 mg/kg - 3 mg/kg i.v. | 59.60 | 95% Confidence Interval 52.67 to 66.52 | Percentage of participants | |
| Percentage of Participants With American College of Rheumatology 20 (ACR20) Response Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Placebo to AIN457 3 mg/kg i.v. | 29.01 | 95% Confidence Interval 22.57 to 35.44 | Percentage of participants | |
| Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | AIN457 6 mg/kg - 3 mg/kg i.v. | 22.45 | 95% Confidence Interval 16.57 to 28.33 | Percentage of participants | |
| Percentage of Participants With Minimal Disease Activity (MDA 5/7) Comparison Between Treatment Groups Using On-responder Imputation at Week 16 (Full Analysis Set) | Placebo to AIN457 3 mg/kg i.v. | 5.28 | 95% Confidence Interval 2.10 to 8.46 | Percentage of participants | |
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set) | AIN457 6 mg/kg - 3 mg/kg i.v. | 47.85 | 95% Confidence Interval 38.15 to 57.54 | Percentage of participants | |
Percentage of Participants With Psoriasis Area and Severity Index 90 (PASi90) Score for Patients With a >= 3% Body Surface Area Psoriasis at Baseline Using On-responder Imputation at Week 16 (Full Analysis Set) | Placebo to AIN457 3 mg/kg i.v. | 6.46 | 95% Confidence Interval 1.83 to 11.09 | Percentage of participants | |
| Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | AIN457 6 mg/kg - 3 mg/kg i.v. | -2.24 | Standard Error 0.103 | scores on a scale | |
| Psoriatic Arthritis Disease Activity Score (PASDAS) Change From Baseline Using Mixed Model Repeated Measures (MMRM) at Week 16 (Full Analysis Set) | Placebo to AIN457 3 mg/kg i.v. | -1.11 | Standard Error 0.103 | scores on a scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AIN457 6 mg/kg - 3 mg/kg i.v. | 191 | |
| Overall Study | STARTED | Placebo to AIN457 3 mg/kg i.v. | 190 | |
| Overall Study | COMPLETED | AIN457 6 mg/kg - 3 mg/kg i.v. | 173 | |
| Overall Study | COMPLETED | Placebo to AIN457 3 mg/kg i.v. | 167 | |
| Overall Study | NOT COMPLETED | AIN457 6 mg/kg - 3 mg/kg i.v. | 18 | |
| Overall Study | NOT COMPLETED | Placebo to AIN457 3 mg/kg i.v. | 23 |
Source ClinicalTrials.gov
Adverse events86
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 6 mg/kg - 3 mg/kg i.v | 9 | 374 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo up to Week 16 | 2 | 190 | |
| other | Nausea | Gastrointestinal disorders | AIN457 6 mg/kg - 3 mg/kg i.v | 11 | 374 | |
| other | Nausea | Gastrointestinal disorders | Placebo up to Week 16 | 2 | 190 | |
| other | Bronchitis | Infections and infestations | AIN457 6 mg/kg - 3 mg/kg i.v | 8 | 374 | |
| other | Bronchitis | Infections and infestations | Placebo up to Week 16 | 0 | 190 | |
| other | COVID-19 | Infections and infestations | AIN457 6 mg/kg - 3 mg/kg i.v | 37 | 374 | |
| other | COVID-19 | Infections and infestations | Placebo up to Week 16 | 7 | 190 | |
| other | Nasopharyngitis | Infections and infestations | AIN457 6 mg/kg - 3 mg/kg i.v | 13 | 374 | |
| other | Nasopharyngitis | Infections and infestations | Placebo up to Week 16 | 3 | 190 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AIN457 6 mg/kg - 3 mg/kg i.v | 0 | 374 |
| Total, all-cause mortality | Placebo up to Week 16 | 1 | 190 |
| Total, other adverse events | AIN457 6 mg/kg - 3 mg/kg i.v | 136 | 374 |
| Total, other adverse events | Placebo up to Week 16 | 35 | 190 |
| Total, serious adverse events | AIN457 6 mg/kg - 3 mg/kg i.v | 22 | 374 |
| Total, serious adverse events | Placebo up to Week 16 | 4 | 190 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AIN457 6 mg/kg - 3 mg/kg i.v vs Placebo up to Week 16: deaths from any cause | Trial comparisons |
| AIN457 6 mg/kg - 3 mg/kg i.v vs Placebo up to Week 16: serious adverse events | Trial comparisons |
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/NCT04209205
GET https://conductscience.org/api/trials/v1/NCT04209205/results?page=2