Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to ... | Completed
Efficacy at 24 Weeks and Safety, To... | Completed
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
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Medical Conditions
  • Rheumatoid Arthritis
Primary Contact Details
Unfortunately contact details are not available for this trial.
Recruitment Status
Completed
Trial source and source ID number
NCT01377012
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
The core and extension studies assessed 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. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Research Details
  • CAIN457F2302 (Core Study): Completed Sep 9 2015

    CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Biological : Secukinumab (AIN457), Biological : Placebo

Study Arm Groups : AIN457 10mg/kg-75mg, AIN457 10mg/kg-150mg, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Core Study: Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20) at Week 24; Week 24; Extension Phase: Percentage of Patients Achieving a American College of Rheumatology Response ACR20, ACR50 and ACR70; up to week 260
Secondary Outcome Measures
    Core Study: Change From Baseline and Week 24 in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI); Baseline, Week 24; Core Study: Change From Baseline at Week 24 in Van Der Heijde Total Modified Sharp Score; Week 24; Core Study Percentage of Patients Achieving Major Clinical Response (Continuous Six-month Period of ACR70 Response During the 1 Year Period) at Week 52; 52 week; Extension Phase: Change in Baseline of RA Disease Activity as Measured by Disease Activity Score (DAS28); week 260; Extension Phase: Proportion of Subjects Achieving Low Disease Activity and Good/Moderate European League Against Rheumatism (EULAR) Responses; up to week 260; Extension Phase: Proportion of Subjects Achieving ACR/(EULAR) Remission; up to week 260; Extension Phase: Changes in Baseline of Quality of Life (Qol) Outcomes Measured by Medical Outcome Short Form SF-36 v2; Baseline, up to week 260; Extension Phase: Immunogenicity Against Secukinumab; up to week 260
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
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
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Salisbury
SP2 8BJ
Cannock
WS11 2XY
Whipps Cross University Hospital
London
London
E11 1NR
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
Argentina, Belgium, Canada, Colombia, Guatemala, Hungary, India, Italy, Japan, Mexico, Panama, Puerto Rico, Thailand, Turkey, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
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 (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CAIN457F2302/E1
Sponsor(s)
Novartis Pharmaceuticals
Key Dates

Recruitment Start Date

Aug 2011

Recruitment End Date

Sep 2015

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

17 Jun 2011

Date updated in source

09 Feb 2017