Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
This study has been completed.
Information provided by:
XOMA (US) LLC
First received: April 23, 2002
Last updated: June 23, 2005
Last verified: September 2004
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Clinical diagnosis of moderate to severe rheumatoid arthritis.
- On stable dose of methotrexate.
- 18 to 80 years of age.
- Less than 275 lbs.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00034203
XOMA (US) LLC
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 23, 2002
||June 23, 2005
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 04, 2013
Connective Tissue Diseases
Immune System Diseases