Trial · NCT01752634
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
NCT01752634, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-05-13
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis. Trials, record NCT01752634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01752634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
- NCT number
- NCT01752634
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 397 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Psoriatic Arthritis
- Interventions
- Secukinumab (AIN457), Placebo
- First posted
- 2012-12-19
- Last updated
- 2020-05-13
- Other registries' IDs
- eudract:2012-004439-22
- Results first posted
- 2020-05-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Week 24 | 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 in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Week 24 | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 75 response was defined as participants achieving \>= 75% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. |
| Secondary | Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Week 24 | PASI is a combined assessment of a lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). The body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for a final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area \* area score weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). PASI 90 response was defined as participants achieving \>= 90% improvement from baseline. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their value was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. |
| Secondary | Change From Baseline in DAS28-CRP | Baseline, Week 24 | The DAS28 is a measure of disease activity based on Swollen and Tender Joint Counts, ESR or CRP and the Patient Global Assessment. A DAS28 score \> 5.1 implies active disease, ≤ 3.2 low disease activity, and \< 2.6 remission. The score can range from 0 - 9.4. The data collected after the patient switched to secukinumab were treated as missing for placebo patients and were analyzed using a mixed-effects repeated measures model. For secukinumab patients, the actual values were used in the analysis. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Change From Baseline in SF36-Physical Component Score | Baseline, Week 24 | The SF-36 is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. Score range is from 0 (no problems) to 100 (unable to perform the activity). SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS was used. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Week 24 | The HAQ-DI assesses a subject's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks 'Over the past week, "are you able to..." perform a particular task'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria | Week 24 | ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their ACR20 was set to nonresponse at Week 24. This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline | Week 24 | Resolution of dactylitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of dactylitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
| Secondary | Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline | Week 24 | Resolution of enthesitis was evaluated in the subset of patients who had disease activity at baseline. In this analysis, a lower percentage is desirable and resolution is defined as complete absence of the symptom. For subjects with early escape at Week 16 or had missing values at Week 24 or discontinued prior to Week 24, their assessment was set to nonresponse at Week 24 (presence of enthesitis). This applied for all treatment regimens in order to minimize bias. The Placebo arm was analyzed as one group, irrespective of the re-randomization, as assessments made under the re-randomized active treatment were not included in this analysis. |
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 | Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Week 24 | Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Week 24 | Psoriasis Subset (≥3% skin involvement with psoriasis at baseline) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Week 24 | Psoriasis Subset (≥3% skin involvement with psoriasis at baseline) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in DAS28-CRP | Baseline, Week 24 | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SF36-Physical Component Score | Baseline, Week 24 | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Week 24 | Full Analysis Set, including only participants with measurements at baseline and Week 24. Participants in the Placebo arm who switched to Secukinumab prior to Week 24 were treated as missing. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Achieving American College of Rheumatology 50 (ACR50) Response Criteria | Week 24 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Dactylitis in the Subset of Subjects Who Had Dactylitis at Baseline | Week 24 | Dactylitis Subset (participants with dactylitis at baseline) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Enthesitis in the Subset of Subjects Who Had Enthesitis at Baseline | Week 24 | Enthesitis Subset (participants with enthesitis at baseline) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Secukinumab (AIN457) 75 mg s.c. | 29 | Participants | ||
| Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Secukinumab (AIN457) 150 mg s.c. | 51 | Participants | ||
| Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Secukinumab (AIN457) 300 mg s.c. | 54 | Participants | ||
| Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria | Placebo s.c. | 15 | Participants | ||
| Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Secukinumab (AIN457) 75 mg s.c. | 14 | Participants | ||
| Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Secukinumab (AIN457) 150 mg s.c. | 28 | Participants | ||
| Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Secukinumab (AIN457) 300 mg s.c. | 26 | Participants | ||
| Number of Participants Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Placebo s.c. | 7 | Participants | ||
| Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Secukinumab (AIN457) 75 mg s.c. | 6 | Participants | ||
| Number of Participants Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis | Secukinumab (AIN457) 150 mg s.c. | 19 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Up to Week 24 (Primary Analysis) | STARTED | Secukinumab (AIN457) 75 mg s.c. | 99 | |
| Up to Week 24 (Primary Analysis) | STARTED | Secukinumab (AIN457) 150 mg s.c. | 100 | |
| Up to Week 24 (Primary Analysis) | STARTED | Secukinumab (AIN457) 300 mg s.c. | 100 | |
| Up to Week 24 (Primary Analysis) | STARTED | Placebo - AIN457 150 mg | 43 | |
| Up to Week 24 (Primary Analysis) | STARTED | Placebo - AIN457 300 mg | 45 | |
| Up to Week 24 (Primary Analysis) | STARTED | Placebo - Not Rerandomized | 10 | |
| Up to Week 24 (Primary Analysis) | COMPLETED | Secukinumab (AIN457) 75 mg s.c. | 93 | |
| Up to Week 24 (Primary Analysis) | COMPLETED | Secukinumab (AIN457) 150 mg s.c. | 95 | |
| Up to Week 24 (Primary Analysis) | COMPLETED | Secukinumab (AIN457) 300 mg s.c. | 97 | |
| Up to Week 24 (Primary Analysis) | COMPLETED | Placebo - AIN457 150 mg | 43 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events604
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 | Any AIN457 75 mg | 11 | 99 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 150 mg | 19 | 193 | |
| other | Diarrhoea | Gastrointestinal disorders | Any AIN457 300 mg | 23 | 251 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 3 | 98 | |
| other | Nausea | Gastrointestinal disorders | Any AIN457 75 mg | 7 | 99 | |
| other | Nausea | Gastrointestinal disorders | Any AIN457 150 mg | 12 | 193 | |
| other | Nausea | Gastrointestinal disorders | Any AIN457 300 mg | 14 | 251 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 98 | |
| other | Fatigue | General disorders | Any AIN457 75 mg | 5 | 99 | |
| other | Fatigue | General disorders | Any AIN457 150 mg | 6 | 193 |
1 to 10 of 604Source ClinicalTrials.gov
See all 604 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Any AIN457 75 mg | 0 | 99 |
| Total, all-cause mortality | Any AIN457 150 mg | 1 | 193 |
| Total, all-cause mortality | Any AIN457 300 mg | 0 | 251 |
| Total, all-cause mortality | Placebo | 0 | 98 |
| Total, other adverse events | Any AIN457 75 mg | 63 | 99 |
| Total, other adverse events | Any AIN457 150 mg | 132 | 193 |
| Total, other adverse events | Any AIN457 300 mg | 171 | 251 |
| Total, other adverse events | Placebo | 39 | 98 |
| Total, serious adverse events | Any AIN457 75 mg | 17 | 99 |
| Total, serious adverse events | Any AIN457 150 mg | 28 | 193 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
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/NCT01752634
GET https://conductscience.org/api/trials/v1/NCT01752634/results?page=2