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

Tracking Information
First Received Date ^ICMJE	April 23, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Official Title ^ICMJE
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: efalizumab
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	August 2003
Primary Completion Date
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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00034203
Responsible Party
Study ID Numbers ^ICMJE	HURA501
Study Sponsor ^ICMJE	XOMA (US) LLC
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	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