Rheumatoid ArthritisPhase 2NCT00034203
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
A Phase 2 study testing efalizumab in people with Rheumatoid Arthritis, run by XOMA (US) LLC at 52 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- efalizumab
- How many people
- Not given
- Where
- 52 sitesUnited States
- Study dates
- Apr 2002to Aug 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of moderate to severe rheumatoid arthritis.
- On stable dose of methotrexate.
- 18 to 80 years of age.
- Less than 275 lbs.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
United States52 sites
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79106
Austin Rheumatology Research
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
State University of New York Health Science Center at Brooklyn
Brooklyn, New York
Clinical Research of West Florida
Clearwater, Florida, 33765
Bassett Healthcare Clinical Pharmacology Research Center
Cooperstown, New York, 13326
nTouch Research Corporation
Decatur, Georgia, 30033
Central Iowa Hospital Corporation
Des Moines, Iowa, 50309
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Tri-State Arthritis and Rheumatology Center, LLC
Evansville, Indiana, 47714
Phase III Clinical Research
Fall River, Massachusetts, 02720
The Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334
Northeast Clinical Research, LLC
Hamden, Connecticut, 06518
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
NEA Clinic
Jonesboro, Arkansas, 72401
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Volunteer Research Group, LLC
Knoxville, Tennessee, 37920
University of California at San Diego
La Jolla, California, 92093-0943
Clinical Research Center of Nevada
Las Vegas, Nevada, 89128
Little Rock Diagnostic Clinic
Little Rock, Arkansas, 72205
UCLA
Los Angeles, California, 90024
Wallace Rheumatic Study Center
Los Angeles, California, 90048
University of Wisconsin, Madison
Madison, Wisconsin, 53792
nTouch Research Corporation
Marietta, Georgia, 30066
Summit Research Solutions, Inc.
Memphis, Tennessee, 38119
Anchor Research Center
Naples, Florida, 34102
Vanderbilt University
Nashville, Tennessee, 37232-2681
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Hospital for Joint Disease, ACRC
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
Physicians' Research Options, LLC
Ogden, Utah, 84403
McBride Clinic, Inc.
Oklahoma City, Oklahoma, 73103
South Puget Sound Clinical Research
Olympia, Washington, 98502
Rheumatology Associates of Central Florida
Orlando, Florida, 32806
Arizona Arthritis Research, PLC
Paradise Valley, Arizona, 85253
nTouch Research Corporation
Pittsburgh, Pennsylvania, 15218
Prem C. Chatpar, M.D.
Plainview, New York, 11803
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Desert Medical Advances
Rancho Mirage, California, 92270
The San Diego Arthritis and Osteoporosis Medical Clinic
San Diego, California, 92120
Pacific Arthritis Center
Santa Maria, California, 93454
Washington University Center for Clinical Studies
St Louis, Missouri, 63110
nTouch Research Corporation
St. Petersburg, Florida, 33710
State University of New York Upstate Medical University
Syracuse, New York, 13210
Tampa Medical Group
Tampa, Florida, 33614
Albert Einstein College of Medicine
The Bronx, New York, 10461
Clinical Research Consultants, Inc.
Trumbull, Connecticut, 06611
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, 85715
nTouch Research Corporation
Vero Beach, Florida, 32962
Palm Beach Research Center
West Palm Beach, Florida, 33409
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
About this study
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- efalizumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efalizumabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2002 (estimated)
- Study startApr 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034203
- Sponsor's protocol ID
- HURA501
- Status last verified
- Sep 2004
- First submitted
- 23 Apr 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT00034203
- Acronym / sponsor ID
- HURA501
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Aug 2003
- First posted
- 25 Apr 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of moderate to severe rheumatoid arthritis.
- On stable dose of methotrexate.
- 18 to 80 years of age.
- Less than 275 lbs.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efalizumab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing efalizumab in people with Rheumatoid Arthritis, run by XOMA (US) LLC at 52 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.