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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
efalizumab
Sponsored by
XOMA (US) LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Rheumatology Associates of North Alabama
  • Arizona Arthritis Research, PLC
  • Advanced Clinical Therapeutics, LLC
  • NEA Clinic
  • Little Rock Diagnostic Clinic
  • University of California at San Diego
  • UCLA
  • Wallace Rheumatic Study Center
  • Boling Clinical Trials
  • Desert Medical Advances
  • The San Diego Arthritis and Osteoporosis Medical Clinic
  • Pacific Arthritis Center
  • Northeast Clinical Research, LLC
  • Clinical Research Consultants, Inc.
  • Clinical Research of West Florida
  • The Center for Rheumatology, Immunology and Arthritis
  • Anchor Research Center
  • Rheumatology Associates of Central Florida
  • nTouch Research Corporation
  • Tampa Medical Group
  • nTouch Research Corporation
  • Palm Beach Research Center
  • nTouch Research Corporation
  • nTouch Research Corporation
  • Tri-State Arthritis and Rheumatology Center, LLC
  • Central Iowa Hospital Corporation
  • Beth Israel Deaconess Medical Center
  • Phase III Clinical Research
  • The Center for Pharmaceutical Research
  • Washington University Center for Clinical Studies
  • Clinical Research Center of Nevada
  • Albert Einstein College of Medicine
  • State University of New York Health Science Center at Brooklyn
  • Bassett Healthcare Clinical Pharmacology Research Center
  • Long Island Jewish Medical Center
  • Hospital for Joint Disease, ACRC
  • Mount Sinai School of Medicine
  • Prem C. Chatpar, M.D.
  • State University of New York Upstate Medical University
  • McBride Clinic, Inc.
  • Altoona Center for Clinical Research
  • nTouch Research Corporation
  • Rheumatic Disease Associates
  • Volunteer Research Group, LLC
  • Summit Research Solutions, Inc.
  • Vanderbilt University
  • Amarillo Center for Clinical Research, Ltd.
  • Austin Rheumatology Research
  • Physicians' Research Options, LLC
  • South Puget Sound Clinical Research
  • University of Wisconsin, Madison

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 23, 2002
Last Updated
June 23, 2005
Sponsor
XOMA (US) LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00034203
Brief Title
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2004
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
XOMA (US) LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
efalizumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Arthritis Research, PLC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Advanced Clinical Therapeutics, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
NEA Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0943
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Wallace Rheumatic Study Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Boling Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Desert Medical Advances
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
The San Diego Arthritis and Osteoporosis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Pacific Arthritis Center
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Northeast Clinical Research, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Clinical Research Consultants, Inc.
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
The Center for Rheumatology, Immunology and Arthritis
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Rheumatology Associates of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
nTouch Research Corporation
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Tampa Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
nTouch Research Corporation
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32962
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
nTouch Research Corporation
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
nTouch Research Corporation
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Tri-State Arthritis and Rheumatology Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Central Iowa Hospital Corporation
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Washington University Center for Clinical Studies
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
State University of New York Health Science Center at Brooklyn
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Bassett Healthcare Clinical Pharmacology Research Center
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Hospital for Joint Disease, ACRC
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Prem C. Chatpar, M.D.
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
McBride Clinic, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
nTouch Research Corporation
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Facility Name
Rheumatic Disease Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Volunteer Research Group, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Summit Research Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2681
Country
United States
Facility Name
Amarillo Center for Clinical Research, Ltd.
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Rheumatology Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Physicians' Research Options, LLC
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
South Puget Sound Clinical Research
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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