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A Biomarker Study of Secukinumab in Rheumatoid Arthritis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01426789
First received: August 12, 2011
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Placebo to Secukinumab (AIN457)
Drug: Secukinumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, 12 Week, Randomized, Double-blind, Placebo-controlled Biomarker Study of Secukinumab (AIN457) in Rheumatoid Arthritis Patients Followed by an Open Label Extension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: To assess ACR20 response rate (20% clinical improvement compared to baseline) at week 12 and change from baseline in DAS28, to find out if this response is associated with any marker present in the patient's blood serum [ Time Frame: Interim analysis after approx. 50 to 100 patients completed 12 weeks of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: to assess ACR50/ACR70 response rate (50% resp. 70% clinical improvement compared to baseline) and check if this response is associated with any marker present in the patient's blood serum. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo to Secukinumab (AIN457)
Experimental: Secukinumab (AIN457) Drug: Secukinumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis
  • Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
  • Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
  • Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints and hsCRP >10mg/L

Exclusion Criteria:

  • Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
  • Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
  • Use of high potency opioid analgesics
  • Pregnant or nursing (lactating) women
  • Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426789

  Show 36 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01426789     History of Changes
Other Study ID Numbers: CAIN457F2208
Study First Received: August 12, 2011
Last Updated: November 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Rheumatoid Arthritis
IgG1K monoclonal antibody
Interleukin-17A neutralizing

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013