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Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

This study has been completed.

Sponsored by: XOMA (US) LLC
Information provided by: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT00034203
  Purpose

The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: efalizumab
Phase II

MedlinePlus related topics:   Rheumatoid Arthritis   

Drug Information available for:   Efalizumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Further study details as provided by XOMA (US) LLC:

Study Start Date:   April 2002
Estimated Study Completion Date:   August 2003

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion criteria:

  • Clinical diagnosis of moderate to severe rheumatoid arthritis.
  • On stable dose of methotrexate.
  • 18 to 80 years of age.
  • Less than 275 lbs.

Exclusion criteria:

  • Joint replacement surgery within 60 days of the start of drug dosing.
  • Intra-articular cortisone injections within 28 days of the start of drug dosing.
  • Pregnancy.
  • History of severe allergic or anaphylactic reactions.
  • Active bacterial, viral, fungal, mycobacterium tuberculosis.
  • Positive PPD test.
  • History of any opportunistic infection.
  • Serious persisting local or systemic infection.
  • History of malignancy within the past five years.
  • Received any vaccine within 28 days of the start of study drug dosing.
  • Joint replacement therapy planned within nine months of the start of study drug dosing.
  • Chronic disorders apart from RA affecting the joints.
  • Significant systemic involvement secondary to RA.
  • COPD, asthma, or other pulmonary disease.
  • Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing.
  • Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing.
  • Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing.
  • Liver disease or abnormal hepatic function.
  • Serum creatinine level > 1.5 mg/dL.
  • Platelet count < 125,000 cells/mm3.
  • WBC count < 3,500 cells/mm3.
  • Seropositive for hepatitis B surface antigen.
  • Seropositive for hepatitis C antibody.
  • Known seropositivity for HIV.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034203

Show 52 study locations  Show 52 Study Locations

Sponsors and Collaborators
XOMA (US) LLC
  More Information


Study ID Numbers:   HURA501
First Received:   April 23, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00034203
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008




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