Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis (EXCEED 1)
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| ClinicalTrials.gov Identifier: NCT02745080 |
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Recruitment Status :
Completed
First Posted : April 20, 2016
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriatic Arthritis | Biological: Secukinumab Biological: Adalimumab | Phase 3 |
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.
| 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 |
|---|---|
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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.
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Biological: Secukinumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
Other Name: AIN457 |
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Active Comparator: Adalimumab 40 mg s.c.
Adalimumab 40 mg administered at Baseline followed by dosing every 2 weeks until Week 50.
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Biological: Adalimumab
Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio |
- 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:
- achieving American College of Rheumatology 20 (ACR20) response
- no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 50 (the last dosing visit)
- 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)
- 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.
- 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:
- achieving American College of Rheumatology 50 (ACR50) response
- no permanent study treatment (secukinumab or adalimumab) discontinuation before or at Week 52
- 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)
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Psoriatic Arthritis secukinumab adalimumab monoclonal antibody CASPAR |
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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 Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Antirheumatic Agents |