Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents. (NURTURE 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01350804
First received: May 9, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

This study will assess the safety and efficacy of secukinumab when added to a background therapy 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
Biological: Abatacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year 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:
  • Efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First key (ranked) secondary objective: Disease Activity Score utilizing CRP (DAS28-CRP) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab is superior to placebo with respect to change from baseline in DAS28-CRP

  • Second key (ranked) secondary objective: Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab is superior to placebo with respect to the change from baseline in HAQ-DI

  • Final key (ranked) secondary objective: ACR50 responder rate [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    To demonstrate that the efficacy of secukinumab is superior to placebo based on the proportion of subjects achieving an ACR50 response


Enrollment: 550
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab 75mg s.c.
Secukinumab 75mg s.c., with 10mg/kg i.v. loading dose
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 150mg s.c.
Secukinumab 150mg s.c., with 10mg/kg i.v. loading dose
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
Active Comparator: Abatacept
Patients on abatacept not responding at Week 16 will be re-randomized 1:1 to secukinumab 75 or 150mg
Biological: Abatacept
Other Name: Orencia

  Eligibility

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

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female patients
  • Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
  • At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >= 6 swollen joints out of 66

WITH at least 1 of the following at screening:

  • Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR
  • Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

  • High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR
  • Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour
  • Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
  • Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)

Exclusion Criteria:

  • Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
  • RA patients functional status class IV according to the ACR 1991 revised criteria
  • Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
  • Previous treatment with any cell-depleting therapies

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: NCT01350804

  Show 117 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: NCT01350804     History of Changes
Other Study ID Numbers: CAIN457F2309, 2011-000102-21
Study First Received: May 9, 2011
Last Updated: June 5, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Brazil: National Health Surveillance Agency
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Sanitary Risks Protection
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: The Italian Medicines Agency
Slovakia: State Institute for Drug Control

Keywords provided by Novartis:
Rheumatoid Arthritis
RA
ACR
inflammatory joints

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

ClinicalTrials.gov processed this record on July 20, 2014