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 | Recruiting
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
Trial Source

Health Conditions
  • Rheumatoid Arthritis
Recruiting
Recruitment Status
NCT01377012
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo; Week 24
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; Week 24; 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; Week 24; 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); 1 Year
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; Argentina; Belgium; Canada; Colombia; Guatemala; Hungary; India; Italy; Japan; Mexico; Panama; Peru; Romania; Thailand; Turkey; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
630
Participant Inclusion 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.
Participant Exclusion 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.
Interventions
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).; [Secukinumab 75mg s.c., Secukinumab 150mg s.c.]; Biological; Placebo; null; [Placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
REASSURE
Scientific 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.
Secondary Trial Identifying Number
2011-000275-13
Website
Sorry, this information is not available
Study Funded By
Novartis Pharmaceuticals
Funder Type
Sorry, this information is not available
Study Sponsored By
Novartis Pharmaceuticals
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Jun 2011

Last Updated

17 Feb 2015

Date Record Refreshed on UKCTG

31 Jul 2015