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A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year 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- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents


Inclusion Criteria:



- Male or non-pregnant, non-lactating female patients

- Presence of RA classified by 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 (Anti-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 millimeter (mm)/1st hour

- 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 or any other DMARD (but not more than 1 DMARD) 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 MTX or other DMARD at maximum tolerated
dose)

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

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 MTX or another DMARD

Outcome Time Frame:

week 24

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Bulgaria: Bulgarian Drug Agency

Study ID:

CAIN457F2309

NCT ID:

NCT01350804

Start Date:

September 2011

Completion Date:

August 2015

Related Keywords:

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

Name

Location

Novartis Investigative SiteChicago, Illinois  60612
Novartis Investigative SiteSouthfield, Michigan  48075
Novartis Investigative SitePortland, Oregon  97239
Novartis Investigative siteNashville, Tennessee  37232
Novartis Investigative SiteSpokane, Washington  99202
Novartis Investigative SiteBoston, Massachusetts  02115
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteSt. Louis, Missouri  63110
Novartis Investigative SiteBuffalo, New York  14263
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteBirmingham, Alabama  35294
Novartis Investigative SiteMiami, Florida  33176-2197
Novartis Investigative SiteBeech Grove, Indiana  46107
Novartis Investigative SiteWitchita, Kansas  67214
Novartis Investigative SiteLouisville, Kentucky  40202
Novartis Investigative SiteNew Orleans, Louisiana  70112
Novartis Investigative SiteMinneapolis, Minnesota  55455
Novartis Investigative SiteOmaha, Nebraska  68198-7681
Novartis Investigative SiteTulsa, Oklahoma  74136
Novartis Investigative SiteSpartanburg, South Carolina  29303
Novartis Investigative SiteDallas, Texas  75235-9179
Novartis Investigative SiteSalt Lake City, Utah  84112
Novartis Investigative SiteMorgantown, West Virginia  26506
Novartis Investigative SiteNorwalk, Connecticut  06856
Novartis Investigative SiteRichmond, Virginia  23230
Novartis Investigative SiteCoeur d'Alene, Idaho  83814
Novartis Investigative SiteBiloxi, Mississippi  39531