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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 : Completed
First Posted : April 20, 2016
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

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

Detailed Description:

The total maximum study duration, including the screening period was up to 76 weeks.

At Baseline, patients whose eligibility was confirmed were randomized to 1 of 2 groups (1:1): Group 1 (secukinumab 300 mg) or Group 2 (adalimumab 40 mg).

In order to maintain the blind, both groups received 1 or 2 placebo s.c. injections to keep consistency in the number of injections at each dosing visit. Secukinumab (300 mg) was available in 2 x 1.0 mL pre-filled syringes (PFS) and adalimumab was available in 1 x 0.4 mL PFS. Placebo (1.0 and 0.5 mL PFS) was also available.

Secukinumab 300 mg s.c injection (2 x 1 mL PFS) was administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks to Week 48.

Adalimumab 40 mg (1 x 0.4 mL PFS) was administered at Baseline followed by dosing every 2 weeks until Week 50.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 853 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 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 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. Percentage of Participants Who Achieved an American College of Rheumatology 20% (ACR20) Response at Week 52 [ Time Frame: 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 Outcome Measures :
  1. Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 52 [ Time Frame: 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.

  2. Percentage of Participants Who Achieved an American College of Rheumatology 50% (ACR50) Response at Week 52 [ Time Frame: 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)

  3. Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) at Week 52 [ Time Frame: 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.

  4. Percentage of Participants Who Achieved Resolution of Enthesitis at Week 52 [ Time Frame: 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.



Information from the National Library of Medicine

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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
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] February 24, 2019
Statistical Analysis Plan  [PDF] October 15, 2019

Additional Information:
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
Results First Posted: January 27, 2021
Last Update Posted: January 27, 2021
Last Verified: January 2021
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
Adalimumab
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents