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 currently recruiting participants.
Verified December 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01350804
First received: May 9, 2011
Last updated: December 9, 2013
Last verified: December 2013
  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:
  • Measure: improvement (change) of the Health Assessment Questionnaire - Disability Index (HAQ-DI) from baseline on secukinumab 75 mg or 150 mg compared to placebo [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to placebo (as originally randomized) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients achieving ACR20 response on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Improvement (change) of the HAQ-DI from baseline on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving major clinical response (continuous six-month period of ACR70 response) on secukinumab 75 mg or 150 mg compared to abatacept [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 548
Study Start Date: September 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350804

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

  Show 188 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: December 9, 2013
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
France: Conseil National de l'Ordre des Médecins
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Mexico: Federal Commission for Sanitary Risks Protection
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovak Republic: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

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 April 17, 2014