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

This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01359943
First received: May 19, 2011
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  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
Biological: 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 215
Study Start Date: August 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: secukinumab 10 mg/kg i.v. and placebo s.c. Biological: secukinumab
secukinumab 10 mg/kg i.v. and placebo s.c.
Experimental: secukinumab 150 mg s.c. and placebo i.v. Biological: secukinumab
150 mg s.c. and placebo i.v.
Placebo Comparator: placebo i.v. and s.c Biological: placebo
placebo i.v. and s.c

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

Contacts
Contact: Novartis Pharmaceuticals 862-778-8300

  Show 38 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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: April 27, 2012
Health Authority: 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
United States: Food and Drug Administration

Keywords provided by Novartis:
Rheumatoid Arthritis
RA
secukinumab
 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
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 May 23, 2013