Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (REASSURE)

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:
NCT01377012
First received: June 17, 2011
Last updated: June 17, 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 (RA) who are intolerant to or have had an inadequate response to anti-tumor necrosis factor (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, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 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:
  • 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:
  • 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 ]
  • change of the van der Heijde total modified Sharp score on secukinumab 75 mg and 150 mg pooled or individual dose is superior 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 ]

Estimated Enrollment: 630
Study Start Date: August 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (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

  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 American College of Rheumatology (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 (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 mm/1st hr
  • 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 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 Japan only: 6 to 25 mg/week)

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 including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
  • 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: NCT01377012

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

  Show 195 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: NCT01377012     History of Changes
Other Study ID Numbers: CAIN457F2302, 2011-000275-13
Study First Received: June 17, 2011
Last Updated: June 17, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Ministry of Social Affairs, Public Health and the Environment
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Guatemala: Ministry of Public Health and Social Assistance
Hungary: Scientific and Medical Research Council Ethics Committee
India: Ministry of Health
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Mexico: Federal Commission for Sanitary Risks Protection
Panama: Ministry of Health
Peru: Ministry of Health
Romania: National Medicines Agency
Thailand: Ministry of Public Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014