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

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Rheumatoid Arthritis
Novartis Pharmaceuticals
1-888-669-6682
See all trial contact details
Primary Contact Details
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.
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Biological : Secukinumab (AIN457), Biological : Placebo

Study Arm Groups : Secukinumab 75mg s.c., Secukinumab 150mg s.c., Placebo

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
Sheffield
S10 2JF
Royal Victoria Infirmary
Newcastle upon Tyne
Tyne and Wear
NE1 4LP
Aintree University Hospitals NHS Foundation Trust
Liverpool
Merseyside
L9 7AL
Blackpool Victoria Hospital
Blackpool
England
FY3 8NR
Dept of Child Health, UHW
Cardiff
South Glamorgan
CF14 4XN
Salisbury
SP2 8BJ
Research Site
London
E11 1NR
Cannock Chase Hospital
Cannock
WS11 2XY
GSK Investigational Site
Blackpool
Lancashire
FY3 7EN
Trial Contact(s)
Primary Trial Contact
Novartis Pharmaceuticals
1-888-669-6682
Other Trial Contacts
Novartis Pharmaceuticals
Countries Recruiting
United States, Argentina, Belgium, Canada, Colombia, Guatemala, Hungary, India, Italy, Japan, Mexico, Panama, Peru, Romania, Thailand, Turkey, United Kingdom
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.
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CAIN457F2302
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Oct 2016

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Jun 2011

Last Updated

17 Feb 2015