Anti-CD20 in Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of rituximab (anti-CD20) in treating systemic lupus erythematosus (SLE).

White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Autoimmunity Centers of Excellence
• Treatments: Rituximab

Criteria

Inclusion Criteria

People may be eligible for this study if they:

• Are 18 to 70 years of age

• Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends

• Have SLE (by the American College of Rheumatology criteria)

• Have had SLE for at least 6 months prior to screening

• Have active SLE disease at the screening visit

• Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart)

• Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment

• Meet blood, liver, and kidney laboratory values set by the protocol

• Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment

• Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before the first week's visit. Oral corticosteroids may be altered as medically necessary after enrollment.

• Have at least 1 elevated autoantibody level at screening visit.

Exclusion Criteria

People will not be eligible for this study if they:

• Are pregnant or breast-feeding

• Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial

• Have cranial neuropathy (a condition affecting the head region)

• Are on blood-thinning agents to prevent blood clotting

• Have a serious skin disease

• Have a certain class of heart disease

• Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia

• Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit

• Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy)

• Have received any experimental drug within 30 days of baseline visit

• Have received any monoclonal antibody or similar medication within 3 months of the baseline visit

• Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks of the baseline visit

• Abuse alcohol or drugs

• Are unwilling or unable to follow the protocol

• Have poor veins for receiving injections.