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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

NCT ID: NCT02798211

Last Updated: 2021-10-07

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2018-12-05

Brief Summary

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

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Detailed Description

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Treatment Period 1 was defined as the period from Randomization through Week 16 (prior to the Week 16 dose). At the start of placebo-controlled Treatment Period 1, patients were randomized via Interactive Response Technology (IRT) in a 2:2:1 ratio to 1 of 3 treatment groups.

Group 1- Secukinumab 300 mg: secukinumab 300 mg (2 s.c. injections of the 150-mg dose) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.

Group 2- Secukinumab 150 mg: secukinumab 150 mg (1 s.c. injection of the 150-mg dose and 1 s.c. injection of placebo) once weekly for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.

Group 3- Placebo: placebo (2 s.c. injections of 150 mg secukinumab placebo per dose) once per week for 5 weeks (at Baseline, Weeks 1, 2, 3, and 4), followed by dosing every 4 weeks.

At each study treatment visit 2 s.c. injections in the form of prefilled syringes (PFS) were administered. This was necessary to maintain the blind, as secukinumab in PFS is available in either 1.0 mL (150 mg) or 2 x 1.0 mL (300 mg). Placebo to secukinumab was also available in 1.0 mL to match the active drug.

Rescue medication was not allowed before completion of Week 16 assessments.

Treatment Period 2 patients receiving secukinumab 300 mg (Group 1) continued to receive the same dose up to Week 48.

At Weeks 16, 28, and 40 patients on secukinumab 150 mg (Group 2) were classified as responders (≥20% improvement from BL in both tender and swollen joint counts) or nonresponders.

* At Weeks 16, 28, and 40 patients on secukinumab 150 mg (Group 2) who were responders continued to receive secukinumab 150 mg (1.0 mL) plus placebo (1.0 mL) every 4 weeks until next evaluation of responder status at Weeks 28 or 40.
* Patients who did not meet the responder criteria at Week 16, 28, or 40 started receiving secukinumab 300 mg s.c. every 4 weeks and continued this dose up to Week 48.
* Patients on placebo (Group 3) regardless of their responder status started receiving secukinumab 300 mg s.c. every 4 weeks from Week 16 up to Week 48.

Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study design displays results combined as two or more Arms/Groups. Patients assigned to Placebo arm in Treatment Period 1 (TP1) may have switched to Secukinumab 300mg in Treatment Period 2 (TP2). Summaries by group were performed cumulatively by actual treatment received (as follows) for every visit until Week 16 groups in Treatment Period 1: · Secukinumab 300mg (Group 1) · Secukinumab 150mg (Group 2) · Placebo (Group 3) For entire treatment period, summaries by treatment group were performed cumulatively by the actual treatment received (as follows) for every visit til Week 52, including patients who switched at Weeks 16, 28, 40. For safety variables · Any Secukinumab 150 mg (Group 2) · Any Secukinumab 300mg (Group 1) · Any Secukinumab (Group 3) Hence, participants who received "Placebo" in TP1 were combined with participants who received "Any Secukinumab" in "Group 3" and "Any Secukinumab 300mg" in "Group 1" in TP2. Safety is presented for the ENTIRE period, including TP1 and TP2
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

secukinumab 300mg s.c. injection

Group Type ACTIVE_COMPARATOR

Secukinumab 300 mg

Intervention Type DRUG

150 mg x 2 s.c. injection

Group 2

secukinumab 150 mg s.c. injection

Group Type ACTIVE_COMPARATOR

Secukinumab 150 mg

Intervention Type DRUG

150 mg s.c. injection

Group 3

Placebo s.c. injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Secukinumab 300 mg

150 mg x 2 s.c. injection

Intervention Type DRUG

Secukinumab 150 mg

150 mg s.c. injection

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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AIN457 AIN457 s.c. injection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

Site Status

Novartis Investigative Site

Little Rock, Arkansas, United States

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Novartis Investigative Site

El Cajon, California, United States

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Novartis Investigative Site

Fountain Valley, California, United States

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Novartis Investigative Site

La Jolla, California, United States

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La Mesa, California, United States

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Novartis Investigative Site

Upland, California, United States

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Novartis Investigative Site

Aventura, Florida, United States

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Novartis Investigative Site

Clearwater, Florida, United States

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DeBary, Florida, United States

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Jacksonville, Florida, United States

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North Naples, Florida, United States

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Palm Harbor, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Duluth, Georgia, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Battle Creek, Michigan, United States

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Kalamazoo, Michigan, United States

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Eagan, Minnesota, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Ridgewood, New Jersey, United States

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Summit, New Jersey, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Lake Success, New York, United States

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Orchard Park, New York, United States

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Potsdam, New York, United States

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Saranac Lake, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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New Bern, North Carolina, United States

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Marion, Ohio, United States

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Perrysburg, Ohio, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Orangeburg, South Carolina, United States

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Novartis Investigative Site

Jackson, Tennessee, United States

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Novartis Investigative Site

Arlington, Texas, United States

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Novartis Investigative Site

Arlington, Texas, United States

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Novartis Investigative Site

Austin, Texas, United States

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Novartis Investigative Site

Dallas, Texas, United States

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Dallas, Texas, United States

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Novartis Investigative Site

Houston, Texas, United States

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Novartis Investigative Site

Mesquite, Texas, United States

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Novartis Investigative Site

San Antonio, Texas, United States

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Novartis Investigative Site

Salt Lake City, Utah, United States

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Novartis Investigative Site

Seattle, Washington, United States

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Novartis Investigative Site

Spokane, Washington, United States

Site Status

Novartis Investigative Site

Santurce, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Nguyen T, Churchill M, Levin R, Valenzuela G, Merola JF, Ogdie A, Orbai AM, Scher JU, Kavanaugh A, Kianifard F, Rollins C, Calheiros R, Chambenoit O. Secukinumab in United States Biologic-Naive Patients With Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled CHOICE Study. J Rheumatol. 2022 Aug;49(8):894-902. doi: 10.3899/jrheum.210912. Epub 2022 Apr 15.

Reference Type DERIVED
PMID: 35428722 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=340

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Other Identifiers

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CAIN457FUS01

Identifier Type: -

Identifier Source: org_study_id

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