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Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00928512
First received: June 25, 2009
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: AIN457
Biological: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous AIN457 Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • efficacy (ACR20 criteria) at various doses of AIN457 compared to placebo as add-on therapy in patients with active RA despite stable treatment with methotrexate (MTX) [ Time Frame: week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the speed of onset of response based on ACR20 and ACR50 [ Time Frame: at 2, 4 and 8 weeks ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of AIN457 by assessing the response to treatment (ACR 50 and 70 criteria, DAS 28) compared to placebo [ Time Frame: at Week 16 ] [ Designated as safety issue: No ]
  • To assess the effect of AIN457 on ACR components, including markers of inflammation (hsCRP and ESR) compared to placebo [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • To assess the immunogenicity, PK/PD of AIN457 and efficacy of AIN457 on quality of life and fatigue [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • To evaluate the overall safety and tolerability of AIN457 [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]

Enrollment: 237
Study Start Date: July 2009
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 1 Biological: AIN457
Experimental: AIN457 2 Biological: AIN457
Experimental: AIN457 3 Biological: AIN457
Experimental: AIN457 4 Biological: AIN457
Placebo Comparator: Placebo Biological: 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 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks
  • At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr

Exclusion Criteria:

  • RA patients functional status class IV classified according to the ACR 1991 revised criteria
  • Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine).
  • Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare 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: NCT00928512

  Show 53 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00928512     History of Changes
Other Study ID Numbers: CAIN457F2201, EudraCT number: 2009-011000-34
Study First Received: June 25, 2009
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Taiwan: Institutional Review Board

Keywords provided by Novartis:
Rheumatoid Arthritis, RA, ACR, inflammatory joints

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 16, 2013