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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis

Thank you

Trial Information

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

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

efficacy (proportion of patients achieving an ACR20 response) at 75 mg or 150 mg of secukinumab (AIN457) compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX)

Outcome Time Frame:

Week 24

Safety Issue:

No

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CAIN457F2302

NCT ID:

NCT01377012

Start Date:

August 2011

Completion Date:

Related Keywords:

  • Rheumatoid Arthritis
  • Rheumatoid Arthritis
  • RA
  • ACR
  • inflammatory joints
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

Novartis Investigative siteNashville, Tennessee  37232
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteDurham, North Carolina  27710
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteTucson, Arizona  85724
Novartis Investigative SiteDenver, Colorado  80218
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteAtlanta, Georgia  30342
Novartis Investigative SiteWitchita, Kansas  67214
Novartis Investigative SiteLouisville, Kentucky  40202
Novartis Investigative SiteNew Orleans, Louisiana  70112
Novartis Investigative SiteBaltimore, Maryland  21201
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteSpartanburg, South Carolina  29303
Novartis Investigative SiteDallas, Texas  75235-9179
Novartis Investigative SiteSalt Lake City, Utah  84112
Novartis Investigative SiteFayetteville, Arkansas  72703
Novartis Investigative SiteLas Vegas, Nevada  89135
Novatis Investigative SiteTorrance, California  90502
Novatis Investigative SitePortland, Oregon  97239