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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034203
First Posted: April 25, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
XOMA (US) LLC
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034203


  Show 52 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
  More Information

ClinicalTrials.gov Identifier: NCT00034203     History of Changes
Other Study ID Numbers: HURA501
First Submitted: April 23, 2002
First Posted: April 25, 2002
Last Update Posted: December 9, 2005
Last Verified: September 2004

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases