Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

NCT01770379 | Terminated Phase 3 Results DMC

• 2 other identifiers: CAIN457F23112011-006058-94
• Study Type: interventional
• Target: 242
• Locations: 16 countries
• Sites: 77

Brief Summary

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, RA, IL-17 blocker, subcutaneous, self-injection, AIN457, AIN457F, secukinumab, anti-TNFα, pre-filled syringe

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).

  ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \[HAQ-DI\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.

  Week 24

Secondary Outcomes (3)

• Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)

  Week 24

• Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)

  Week 24

• Percentage of Participants Achieving ACR50

  Week 24

Study Arms (3)

Secukinumab 75 mg

EXPERIMENTAL

Secukinumab 75 mg s.c.

Biological: Secukinumab (AIN457)

Secukinumab 150 mg

EXPERIMENTAL

Secukinumab 150 mg s.c.

Biological: Secukinumab (AIN457)

Placebo

PLACEBO COMPARATOR

Placebo patients will be re-randomized 1:1 to secukinumab 75 or 150mg s.c. (non-responders at Week 16 will be re-assigned to new treatment at Week 16; responders at Week 16 will be re-assigned to new treatment at Week 24)

Biological: Placebo

Interventions

Secukinumab (AIN457) BIOLOGICAL

Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17)

Also known as: AIN457

Secukinumab 150 mg; Secukinumab 75 mg

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (77)

Novartis Investigative Site

Peoria, Arizona, 85381, United States

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Novartis Investigative Site

Santa Monica, California, 90404, United States

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Upland, California, 91786, United States

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Miami, Florida, 33135, United States

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Pembroke Pines, Florida, 33026, United States

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Zephyrhills, Florida, 33542, United States

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Cumberland, Maryland, 21502, United States

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Edina, Minnesota, 55435, United States

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Tupelo, Mississippi, 38801, United States

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Lees Summit, Missouri, 64086, United States

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St Louis, Missouri, 63128, United States

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Reno, Nevada, 89502, United States

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Albuquerque, New Mexico, 87102, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73134, United States

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North Charleston, South Carolina, 29406, United States

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Rapid City, South Dakota, 57701, United States

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Jackson, Tennessee, 38305, United States

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Nashville, Tennessee, 37203-1424, United States

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Amarillo, Texas, 79124, United States

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Benbrook, Texas, 76126, United States

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Houston, Texas, 77005, United States

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Novartis Investigative Site

Houston, Texas, 77034, United States

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Mesquite, Texas, 75150, United States

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Mar del Plata, Buenos Aires, B7600FZN, Argentina

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Rosario, Santa Fe Province, S2000CXH, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Salvador, Estado de Bahia, 40050-410, Brazil

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Juiz de Fora, Minas Gerais, 36010-570, Brazil

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Curitiba, Paraná, 80030-110, Brazil

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São Paulo, São Paulo, 04266-010, Brazil

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Cali, Colombia, Colombia

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Bogotá, 110221, Colombia

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Novartis Investigative Site

Uherské Hradiště, Czech Republic, 686 01, Czechia

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Prague, 128 50, Czechia

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Santo Domingo, Republica Dominicana, Dominican Republic

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Hanover, Germany, 30625, Germany

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Bad Doberan, 18209, Germany

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Göttingen, 37075, Germany

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Hamburg, 22081, Germany

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Novartis Investigative Site

Magdeburg, 39110, Germany

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Pirna, 01796, Germany

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Athens, GR, 115 27, Greece

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Heraklion, GR, 700 13, Greece

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Athens, 115 27, Greece

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Guatemala City, Departamento de Guatemala, 01010, Guatemala

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Secunderabad, Andhra Pradesh, 500003, India

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Pune, Maharashtra, 411 040, India

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Pune, Maharashtra, 411007, India

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New Delhi, National Capital Territory of Delhi, 110 060, India

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Jaipur, Rajasthan, 302013, India

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Bergamo, BG, 24128, Italy

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Catania, CT, 95100, Italy

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Roma, RM, 00152, Italy

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Verona, VR, 37100, Italy

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Bologna, 40138, Italy

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Fukuoka, Fukuoka, 813-0017, Japan

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Takasaki, Gunma, 370-0053, Japan

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Hiroshima, Hiroshima, 733-0032, Japan

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Yokohama, Kanagawa, 230-0023, Japan

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Kumamoto, Kumamoto, 862-0976, Japan

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Miyagi-gun, Miyagi, 981-0112, Japan

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Nagano, Nagano, 380-8582, Japan

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Sasebo, Nagasaki, 857-1165, Japan

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Setouchi, Okayama-ken, 701-4264, Japan

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Novartis Investigative Site

Kawachi-Nagano, Osaka, 586-8521, Japan

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Tokorozawa, Saitama, 359-1111, Japan

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Novartis Investigative Site

Hamamatsu, Shizuoka, 430-8558, Japan

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Novartis Investigative Site

Toyama, Toyama, 930-0138, Japan

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Novartis Investigative Site

Panama City, Provincia de Panamá, 0823-01510, Panama

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Novartis Investigative Site

Panama City, Provincia de Panamá, Panama

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Novartis Investigative Site

Lisbon, Portugal, 1050-034, Portugal

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Novartis Investigative Site

Lisbon, Portugal, 1600-190, Portugal

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Novartis Investigative Site

Panorama, Western Cape, 7500, South Africa

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Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 137-701, South Korea

Location

Related Publications (1)

• Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

  PMID: 31087226 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was terminated early due to the decision (unrelated to safety) to discontinue the clinical development program for secukinumab in Rheumatoid Arthritis, with last patient last visit (LPLV) on 11-May-2015.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: January 17, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 21, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-06

Locations

BR (4); US (25); KR (2); JP (13); GR (3); IT (5); IN (5); DO (1); AR (3); DE (6); PA (2); CZ (2); GU (1); ZA (1); CO (2); PT (2)