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Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

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ClinicalTrials.gov Identifier: NCT02798211
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Secukinumab Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks
Actual Study Start Date : June 27, 2016
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab

Arm Intervention/treatment
Active Comparator: Group 1
secukinumab 300mg
Drug: Secukinumab
300 mg

Active Comparator: Group 2
secukinumab 150 mg
Drug: Secukinumab
150 mg

Placebo Comparator: Group 3
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 300 mg vs. Placebo [ Time Frame: 16 Weeks ]
    A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two of the following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR).


Secondary Outcome Measures :
  1. Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 150 mg vs. Placebo [ Time Frame: 16 weeks ]
    A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two of the following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)

  2. Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline [ Time Frame: 16 Weeks ]
  3. Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline [ Time Frame: 16 Weeks ]
  4. Percent of Patients Achieving ACR50 and 70 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo [ Time Frame: 16 Weeks ]
    A patient will be considered as improved according the ACR50 or 70 criteria if she/he has at least 50 or 70 % improvement in the two of the following measures: Tender joint count, Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)

  5. Percent of patients Achieving a PASI75, 90 or 100 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline [ Time Frame: 16 Weeks ]
    A 75, 90 or 100% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75, 90 or 100) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis.

  6. Change From Baseline in DAS28-CRP for Secukinumab 300 or 150 mg [ Time Frame: 16 weeks ]
    DAS28-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS28-CRP below the value of 2.6 is interpreted as Remission.DAS28-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters.

  7. Change From Baseline in HAQ-DI for Secukinumab 300 or 150 mg [ Time Frame: 16 Weeks ]
    HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotors activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - 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. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).



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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

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female patients at least 18 years of age
  • Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
  • Rheumatoid factor and/or anti-CCP antibodies negative at screening
  • A target skin psoriatic lesion and a PASI score of 1 or greater

Exclusion Criteria:

  • Chest X-ray with evidence of ongoing infectious or malignant process
  • Patients who ever received biologic immunomodulating agents including those targeting TNFα, IL-6 and IL-12/23 investigational or approved

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): NCT02798211


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Sponsors and Collaborators
Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02798211     History of Changes
Other Study ID Numbers: CAIN457FUS01
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
PsA, ACR, CASPAR

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs