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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02745080
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Biological: Secukinumab Biological: Adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 854 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : December 30, 2019


Arm Intervention/treatment
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.
Biological: Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Other Name: (AIN457)

Active Comparator: Adalimumab 40 mg s.c.
Adalimumab 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 50.
Biological: Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio




Primary Outcome Measures :
  1. 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)]


Secondary Outcome Measures :
  1. 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

  2. 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)]

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Key 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02745080


Locations
Show Show 156 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02745080    
Other Study ID Numbers: CAIN457F2366
2015-004477-32 ( EudraCT Number )
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Psoriatic Arthritis
secukinumab
adalimumab
monoclonal antibody
CASPAR
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents