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

NCT02798211 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CAIN457FUS01
• Study Type: interventional
• Target: 258
• Locations: 2 countries
• Sites: 58

Brief Summary

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.

Conditions

Psoriatic Arthritis

Keywords

PsA; ACR; CASPAR; inflammatory arthritis; spondylitis

Outcome Measures

Primary Outcomes (1)

• Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16

  A patient was considered as improved according to the ACR20 criteria if she/he had at least 20% improvement in 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). Odds ratio, 95% confidence interval for odds ratio, and p-value are from a logistic regression model with treatment (3 treatment groups), methotrexate usage at baseline (yes, no) and body weight (kg) as explanatory variables.

  16 Weeks

Secondary Outcomes (11)

• Percentage of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Week 16

  Week 16

• Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline (SPARCC) at Week 16

  16 Weeks

• Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (LEI)

  16 Weeks

• Percentage of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Week 16 (Combined SPARCC and LEI)

  16 Weeks

• Percentage of Patients Achieving ACR50 Response Criteria on Secukinumab 300 or 150 mg vs. Placebo at Week 16

  16 Weeks

Other Outcomes (6)

• Number and Percentage of Patients With ACR20 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)

  up to 52 weeks

• Number and Percentage of Patients With ACR50, ACR70 Response by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)

  up to 52 weeks

• Number and Percentage of Patients With Presence of Dactylitis by Visit - in Entire Treatment Period (up to Week 52) (Non-responder Imputation)

  up to 52 weeks

Study Arms (3)

Group 1

ACTIVE COMPARATOR

secukinumab 300mg s.c. injection

Drug: Secukinumab 300 mg

Group 2

ACTIVE COMPARATOR

secukinumab 150 mg s.c. injection

Drug: Secukinumab 150 mg

Group 3

PLACEBO COMPARATOR

Placebo s.c. injection

Other: Placebo

Interventions

Secukinumab 300 mg DRUG

150 mg x 2 s.c. injection

Also known as: AIN457

Group 1

Secukinumab 150 mg DRUG

150 mg s.c. injection

Also known as: AIN457

Group 2

Placebo OTHER

Placebo

Also known as: s.c. injection

Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (58)

Novartis Investigative Site

Birmingham, Alabama, 35205, United States

Location

Novartis Investigative Site

Little Rock, Arkansas, 72205, United States

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Novartis Investigative Site

El Cajon, California, 92020, United States

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Novartis Investigative Site

Fountain Valley, California, 92708, United States

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Novartis Investigative Site

La Jolla, California, 92093, United States

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Novartis Investigative Site

La Mesa, California, 91942, United States

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Novartis Investigative Site

Upland, California, 91786, United States

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Novartis Investigative Site

Aventura, Florida, 33180, United States

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Novartis Investigative Site

Clearwater, Florida, 33765, United States

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Novartis Investigative Site

DeBary, Florida, 32713, United States

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Novartis Investigative Site

Jacksonville, Florida, 32207, United States

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Novartis Investigative Site

North Naples, Florida, 34102, United States

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Novartis Investigative Site

Palm Harbor, Florida, 34684, United States

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Novartis Investigative Site

Pensacola, Florida, 32514, United States

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Novartis Investigative Site

Plantation, Florida, 33324, United States

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Novartis Investigative Site

Sarasota, Florida, 34239, United States

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Novartis Investigative Site

Tampa, Florida, 33609, United States

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Novartis Investigative Site

Tampa, Florida, 33613, United States

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Novartis Investigative Site

Duluth, Georgia, 30096, United States

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Novartis Investigative Site

Baltimore, Maryland, 21224, United States

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Novartis Investigative Site

Boston, Massachusetts, 02115, United States

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Novartis Investigative Site

Worcester, Massachusetts, 01655, United States

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Novartis Investigative Site

Battle Creek, Michigan, 49015, United States

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Novartis Investigative Site

Kalamazoo, Michigan, 49008, United States

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Novartis Investigative Site

Eagan, Minnesota, 55121, United States

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Novartis Investigative Site

Lincoln, Nebraska, 68516, United States

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Novartis Investigative Site

Las Vegas, Nevada, 89106, United States

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Novartis Investigative Site

Ridgewood, New Jersey, 07450, United States

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Novartis Investigative Site

Summit, New Jersey, 07901, United States

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Novartis Investigative Site

Albany, New York, 12206, United States

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Novartis Investigative Site

Brooklyn, New York, 11201, United States

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Novartis Investigative Site

Lake Success, New York, 11402, United States

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Novartis Investigative Site

Orchard Park, New York, 14127, United States

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Novartis Investigative Site

Potsdam, New York, 13676, United States

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Novartis Investigative Site

Saranac Lake, New York, 12983, United States

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Novartis Investigative Site

Charlotte, North Carolina, 28226, United States

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Novartis Investigative Site

Greensboro, North Carolina, 27408, United States

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Novartis Investigative Site

New Bern, North Carolina, 28562, United States

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Novartis Investigative Site

Marion, Ohio, 43302, United States

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Novartis Investigative Site

Perrysburg, Ohio, 43551, United States

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Novartis Investigative Site

Duncansville, Pennsylvania, 16635, United States

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Novartis Investigative Site

Philadelphia, Pennsylvania, 19104, United States

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Novartis Investigative Site

Charleston, South Carolina, 29460, United States

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Novartis Investigative Site

Greenville, South Carolina, 29601, United States

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Novartis Investigative Site

Orangeburg, South Carolina, 29118-2475, United States

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Novartis Investigative Site

Jackson, Tennessee, 38305, United States

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Novartis Investigative Site

Arlington, Texas, 76014, United States

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Novartis Investigative Site

Arlington, Texas, 77373, United States

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Novartis Investigative Site

Austin, Texas, 78731, United States

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Novartis Investigative Site

Dallas, Texas, 75231, United States

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Novartis Investigative Site

Dallas, Texas, 75246, United States

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Novartis Investigative Site

Houston, Texas, 77074, United States

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Novartis Investigative Site

Mesquite, Texas, 75150, United States

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Novartis Investigative Site

San Antonio, Texas, 78229, United States

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Novartis Investigative Site

Salt Lake City, Utah, 84132, United States

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Novartis Investigative Site

Seattle, Washington, 98122, United States

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Novartis Investigative Site

Spokane, Washington, 99204, United States

Location

Novartis Investigative Site

Santurce, 00909, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 35428722 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis; Spondylitis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Infectious; Infections

Limitations and Caveats

Period 2 (week 16 up to 52 weeks) contained only exploratory outcomes. AEs are presented cumulitively

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (862) 778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: June 27, 2016
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: October 7, 2021
• Results First Posted: January 28, 2021

Record last verified: 2021-10

Locations

US (57); PR (1)