Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01359943
First received: May 19, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The study will compare the efficacy and assess the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: secukinumab (AIN457)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an i.v. or s.c. Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy as measured by the proportion of patients who achieve ACR20. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy as measured by the proportion of patients who achieve ACR 50 and ACR 70. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in Disease Activity Score (DAS) 28 response (using hsCRP or ESR) and EULAR response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in ACR components, including markers of inflammation (hsCRP and ESR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in HAQ-DI score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability will be assessed by the absolute and relative frequency of patients with adverse events, clinically notable laboratory values, clinically notable vital signs abnormalities, injection site reactions and immunogenicity. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 221
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab 10 mg/kg i.v. loading
secukinumab 10mg/kg i.v. loading at Weeks 0, 2 & 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
Biological: secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Experimental: secukinumab 150 mg s.c. loading
secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 & 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
Biological: secukinumab (AIN457)
Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
Placebo Comparator: placebo
placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
Drug: placebo

  Eligibility

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

Inclusion criteria:

  • presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
  • must have been taking MTX for at least 3 months before randomization and must currently be on a stable dose of MTX for at least 4 weeks before randomization.
  • At Baseline: Disease activity criteria defined by >6 tender joints out of 68 and >6 swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28

Exclusion criteria:

  • RA patients functional status class IV according to the ACR 1991 revised criteria
  • Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
  • Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
  • Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
  • Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359943

  Show 39 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01359943     History of Changes
Other Study ID Numbers: CAIN457F2206, 2010-024516-34
Study First Received: May 19, 2011
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Hungary: Institutional Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: The Central Register of Clinical Trials
Slovakia: State Institute for Drug Control

Keywords provided by Novartis:
Rheumatoid Arthritis
RA
secukinumab
AIN457
inflammatory joints
American College of Rheumatology
ACR

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Antibodies, Monoclonal
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014