Clinical trial NCT00034203: Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2002-04-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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.

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