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Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (EXCEED 1)

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ClinicalTrials.gov Identifier: NCT02745080
Recruitment Status : Recruiting
First Posted : April 20, 2016
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

April 1, 2016
April 20, 2016
December 6, 2018
April 3, 2017
November 14, 2019   (Final data collection date for primary outcome measure)
American College of Rheumatology 20 (ACR20) response [ Time Frame: 52 weeks ]
An ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate(ESR) or high sensitivity C-reactive protein (hsCRP)]
American College of Rheumatology 50 (ACR50) response [ Time Frame: 52 weeks ]
An ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate(ESR) or high sensitivity C-reactive protein (hsCRP)]
Complete list of historical versions of study NCT02745080 on ClinicalTrials.gov Archive Site
  • PASI90 [ Time Frame: 52 weeks ]
    PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline
  • ACR50 response [ Time Frame: 52 weeks ]
    An ACR50 response is defined by at least 50% decrease in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline [ Time Frame: 52 weeks ]
    The disability assessment component of the HAQ assesses a subjects 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 extremeties.
  • Resolution of enthesitis [ Time Frame: 52 weeks ]
    Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution is defined as the absence of recorded enthesitis; conducted by the study assessor.
  • Psoriatic Area and Severity Index 75 (PASI75) [ Time Frame: 52 weeks ]
    PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline
  • PASI90 [ Time Frame: 52 weeks ]
    PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline
  • ACR20 response [ Time Frame: 52 weeks ]
    An ACR20 response is defined by at least 20% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]
  • Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline [ Time Frame: 52 weeks ]
    The disability assessment component of the HAQ assesses a subjects 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 extremeties.
  • Resolution of enthesitis [ Time Frame: 52 weeks ]
    Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. Resolution is defined as the absence of recorded enthesitis; conducted by the study assessor.
Not Provided
Not Provided
 
Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis
A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis
The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy and adalimumab monotherapy in patients with active psoriatic arthritis who are naïve to biologic therapy and are intolerant or having inadequate response to conventional DMARDs
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • Biological: Secukinumab
    Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
    Other Name: (AIN457)
  • Biological: Adalimumab
    Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
  • Experimental: Secukinumab 300 mg s.c.
    Secukinumab 300 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 48.
    Intervention: Biological: Secukinumab
  • Active Comparator: Adalimumab 40 mg s.c.
    Adalimumab 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 50.
    Intervention: Biological: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
850
852
March 4, 2020
November 14, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD.

Exclusion Criteria:

  • Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents.

Other protocol-defined inclusion/exclusion criteria may apply

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
Australia,   Bulgaria,   Canada,   Czechia,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   Iceland,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   United Kingdom,   United States
 
 
NCT02745080
CAIN457F2366
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Not Provided
Novartis
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP