Trial · NCT02745080

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

NCT02745080, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-01-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis. Trials, record NCT02745080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02745080

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
NCT number: NCT02745080
Status: Completed
Phases: Phase 3
Enrollment: 853 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Psoriatic Arthritis
Interventions: Secukinumab, Adalimumab
First posted: 2016-04-20
Last updated: 2021-01-27
Other registries' IDs: eudract:2015-004477-32
Results first posted: 2021-01-27

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52	Week 52	Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The primary endpoint is the proportion of patients with monotherapy ACR20 response at Week 52 where monotherapy ACR20 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 20 (ACR20) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit) 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
Secondary	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52	Week 52	The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
Secondary	Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52	Week 52	Clinical response, failure to permanently discontinue study medication prematurely, and lack of need for rescue medication was required for a patient to achieve treatment success. The secondary endpoint is the proportion of patients with monotherapy ACR50 response at Week 52 where monotherapy ACR50 response is defined as meeting the following 3 conditions: 1. achieving American College of Rheumatology 50 (ACR50) response 2. no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52 3. no use of conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs) cDMARDs (including Methotrexate (MTX)) after Week 36 (regardless of the starting time of taking cDMARDs)
Secondary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52	Baseline, Week 52	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.
Secondary	Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52	Week 52	Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution was defined as the absence of recorded enthesitis; conducted by the study assessor.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52	Week 52	Full Analysis Set (FAS)	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52	Week 52	Psoriasis Subset of the Full Analysis Set (FAS)	Percentage of Participants	NUMBER
SECONDARY	Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52	Week 52	Full Analysis Set (FAS)	Percentage of Participants	NUMBER
SECONDARY	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52	Baseline, Week 52	Full Analysis Set (FAS)	Unit on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52	Week 52	Enthesitis Subset (LEI) of the Full Analysis Set (FAS)	Percentage of Participants	NUMBER

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52	Secukinumab 300 mg s.c.	67.4	95% Confidence Interval 62.8 to 71.7	Percentage of Participants
Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52	Adalimumab 40 mg s.c.	61.5	95% Confidence Interval 56.8 to 66.0	Percentage of Participants
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52	Secukinumab 300 mg s.c.	65.4	95% Confidence Interval 58.8 to 71.5	Percentage of Participants
Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52	Adalimumab 40 mg s.c.	43.2	95% Confidence Interval 36.5 to 50.2	Percentage of Participants
Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52	Secukinumab 300 mg s.c.	49.0	95% Confidence Interval 44.3 to 53.7	Percentage of Participants
Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52	Adalimumab 40 mg s.c.	44.8	95% Confidence Interval 40.1 to 49.5	Percentage of Participants
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52	Secukinumab 300 mg s.c.	-0.58	Standard Error 0.027	Unit on a scale
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52	Adalimumab 40 mg s.c.	-0.56	Standard Error 0.027	Unit on a scale
Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52	Secukinumab 300 mg s.c.	60.5	95% Confidence Interval 54.1 to 66.6	Percentage of Participants
Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52	Adalimumab 40 mg s.c.	54.2	95% Confidence Interval 48.2 to 60.2	Percentage of Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Secukinumab 300 mg s.c.	426
Overall Study	STARTED	Adalimumab 40 mg s.c.	427
Overall Study	COMPLETED	Secukinumab 300 mg s.c.	371
Overall Study	COMPLETED	Adalimumab 40 mg s.c.	338
Overall Study	NOT COMPLETED	Secukinumab 300 mg s.c.	55
Overall Study	NOT COMPLETED	Adalimumab 40 mg s.c.	89

Source ClinicalTrials.gov

Adverse events294

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
other	Diarrhoea	Gastrointestinal disorders	AIN457 300 mg	32	426
other	Diarrhoea	Gastrointestinal disorders	Adalimumab 40 mg	37	427
other	Diarrhoea	Gastrointestinal disorders	Total	69	853
other	Injection site reaction	General disorders	AIN457 300 mg	4	426
other	Injection site reaction	General disorders	Adalimumab 40 mg	28	427
other	Injection site reaction	General disorders	Total	32	853
other	Bronchitis	Infections and infestations	AIN457 300 mg	16	426
other	Bronchitis	Infections and infestations	Adalimumab 40 mg	27	427
other	Bronchitis	Infections and infestations	Total	43	853
other	Nasopharyngitis	Infections and infestations	AIN457 300 mg	88	426

1 to 10 of 294Source ClinicalTrials.gov

See all 294 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AIN457 300 mg	1	426
Total, all-cause mortality	Adalimumab 40 mg	0	427
Total, all-cause mortality	Total	1	853
Total, other adverse events	AIN457 300 mg	226	426
Total, other adverse events	Adalimumab 40 mg	236	427
Total, other adverse events	Total	462	853
Total, serious adverse events	AIN457 300 mg	37	426
Total, serious adverse events	Adalimumab 40 mg	36	427
Total, serious adverse events	Total	73	853

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32386593	DERIVED	PubMed
37097894	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02745080

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API reference For AI assistants