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

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT00034203

Run by

XOMA (US) LLC

Starts

2002-04-01

Expected to finish

2003-08-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Arizona Arthritis Research, PLC — Paradise Valley, Arizona, United States
• Advanced Clinical Therapeutics, LLC — Tucson, Arizona, United States
• NEA Clinic — Jonesboro, Arkansas, United States
• Little Rock Diagnostic Clinic — Little Rock, Arkansas, United States
• University of California at San Diego — La Jolla, California, United States
• UCLA — Los Angeles, California, United States
• Wallace Rheumatic Study Center — Los Angeles, California, 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
• Northeast Clinical Research, LLC — Hamden, Connecticut, United States
• Clinical Research Consultants, Inc. — Trumbull, Connecticut, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• The Center for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• Anchor Research Center — Naples, Florida, United States
• Rheumatology Associates of Central Florida — Orlando, Florida, United States
• nTouch Research Corporation — St. Petersburg, Florida, United States
• Tampa Medical Group — Tampa, Florida, United States
• nTouch Research Corporation — Vero Beach, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• nTouch Research Corporation — Decatur, Georgia, United States
• nTouch Research Corporation — Marietta, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.