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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034203
• Other study ID #: HURA501
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2002
• Last updated: June 23, 2005
• Start date: April 2002
• Est. completion date: August 2003

Study information

• Verified date: September 2004
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• efalizumab

Locations

Country	Name	City	State
United States	Amarillo Center for Clinical Research, Ltd.	Amarillo	Texas
United States	Austin Rheumatology Research	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Bassett Healthcare Clinical Pharmacology Research Center	Cooperstown	New York
United States	nTouch Research Corporation	Decatur	Georgia
United States	Central Iowa Hospital Corporation	Des Moines	Iowa
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Tri-State Arthritis and Rheumatology Center, LLC	Evansville	Indiana
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	The Center for Rheumatology, Immunology and Arthritis	Ft. Lauderdale	Florida
United States	Northeast Clinical Research, LLC	Hamden	Connecticut
United States	Rheumatology Associates of North Alabama	Huntsville	Alabama
United States	NEA Clinic	Jonesboro	Arkansas
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Volunteer Research Group, LLC	Knoxville	Tennessee
United States	University of California at San Diego	La Jolla	California
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Little Rock Diagnostic Clinic	Little Rock	Arkansas
United States	UCLA	Los Angeles	California
United States	Wallace Rheumatic Study Center	Los Angeles	California
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	nTouch Research Corporation	Marietta	Georgia
United States	Summit Research Solutions, Inc.	Memphis	Tennessee
United States	Anchor Research Center	Naples	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Hospital for Joint Disease, ACRC	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Physicians' Research Options, LLC	Ogden	Utah
United States	McBride Clinic, Inc.	Oklahoma City	Oklahoma
United States	South Puget Sound Clinical Research	Olympia	Washington
United States	Rheumatology Associates of Central Florida	Orlando	Florida
United States	Arizona Arthritis Research, PLC	Paradise Valley	Arizona
United States	nTouch Research Corporation	Pittsburgh	Pennsylvania
United States	Prem C. Chatpar, M.D.	Plainview	New York
United States	Boling Clinical Trials	Rancho Cucamonga	California
United States	Desert Medical Advances	Rancho Mirage	California
United States	The San Diego Arthritis and Osteoporosis Medical Clinic	San Diego	California
United States	Pacific Arthritis Center	Santa Maria	California
United States	Washington University Center for Clinical Studies	St. Louis	Missouri
United States	nTouch Research Corporation	St. Petersburg	Florida
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Tampa Medical Group	Tampa	Florida
United States	Clinical Research Consultants, Inc.	Trumbull	Connecticut
United States	Advanced Clinical Therapeutics, LLC	Tucson	Arizona
United States	nTouch Research Corporation	Vero Beach	Florida
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Rheumatic Disease Associates	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States,