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Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00669942
First received: April 29, 2008
Last updated: May 31, 2012
Last verified: May 2012
History of Changes
  Purpose

Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: AIN457
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • as measured by percentage of ACR20 responders) of 1 mg/kg, 3 mg kg/kg and 10mg/kg dose (or maximum tolerated dose) of active or placebo [ Time Frame: Day 43 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the relationship of potential biological and pharmacogenomic markers of AIN457 activity with pharmacokinetics and clinical efficacy outcomes by assessing the preliminary biologic activity/pharmacodynamics of AIN457 [ Time Frame: throughout the duration of the study ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: December 2005
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: AIN457
Three treatment groups and 3 different dose levels plus placebo
Other Name: (AIN457), a fully human recombinant IgG1 antibody.
Experimental: 2 Biological: AIN457
Three treatment groups and 3 different dose levels plus placebo
Other Name: (AIN457), a fully human recombinant IgG1 antibody.
Experimental: 3 Biological: AIN457
Three treatment groups and 3 different dose levels plus placebo
Other Name: (AIN457), a fully human recombinant IgG1 antibody.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
  • Post menopausal or surgically sterile female patients are allowed. Women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
  • Patients must have a diagnosis of active rheumatoid arthritis of stages I, II or III (ACR 1987 revised classification for criteria for RA). Disease duration of at least 6 months prior to randomization is essential

Exclusion Criteria:

  • Current treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy).
  • Patients with congestive heart failure or poorly controlled diabetes mellitus (HbA1c value ≥10%).
  • Presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or SLE that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
  • History of renal trauma, glomerulonephritis or patient with one kidney.
  • Pregnant or breastfeeding women will be excluded.
  • A positive tuberculin skin test.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00669942

  Show 23 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Novartis investigator site
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00669942     History of Changes
Other Study ID Numbers: CAIN457A2101
Study First Received: April 29, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Singapore: Health Sciences Authority

Keywords provided by Novartis:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013