Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents. (REASSURE2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01770379
First received: October 16, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: Secukinumab (AIN457)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety, Tolerability and Usability up to 5 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • ACR20 responder rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo based on the proportion of patients achieving an ACR20 response


Secondary Outcome Measures:
  • Disease Activity Score utilizing CRP (DAS28-CRP) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo with respect to change from baseline in DAS28-CRP

  • Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo with respect to the improvement (change) from baseline in HAQ-DI

  • ACR50 responder rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab 75 mg or 150 mg at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR50 response


Estimated Enrollment: 234
Study Start Date: October 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab 75 mg
Secukinumab 75 mg s.c.
Biological: Secukinumab (AIN457)
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)
Other Name: AIN457
Experimental: Secukinumab 150 mg
Secukinumab 150 mg s.c.
Biological: Secukinumab (AIN457)
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)
Other Name: AIN457
Placebo Comparator: Placebo
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration Exclusion Criteria:

  • Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770379

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 123 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01770379     History of Changes
Other Study ID Numbers: CAIN457F2311, 2011-006058-94
Study First Received: October 16, 2012
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Republic of Korea: Ministry of Food and Drug Safety (MFDS)
Brazil: National Health Surveillance Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Guatemala: Ministry of Public Health and Social Assistance
India: Ministry of Health
Panama: Ministry of Health
Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
Ecuador: Public Health Ministry
Greece: National Organization of Medicines
India: Drugs Controller General of India
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Portugal: National Pharmacy and Medicines Institute
South Africa: Medicines Control Council

Keywords provided by Novartis:
Rheumatoid Arthritis, RA, IL-17 blocker, subcutaneous, self-injection, AIN457, AIN457F, secukinumab, anti-TNFα, pre-filled syringe

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014