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

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.
ClinicalTrials.gov Identifier: NCT00034203
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
XOMA (US) LLC

Tracking Information
First Submitted Date  ICMJE April 23, 2002
First Posted Date  ICMJE April 25, 2002
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Official Title  ICMJE Not Provided
Brief Summary The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: efalizumab
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00034203
Other Study ID Numbers  ICMJE HURA501
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE XOMA (US) LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account XOMA (US) LLC
Verification Date September 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP