Status:
COMPLETED
Anti-CD20 Antibody Therapy for Sjogren's Syndrome
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Autoimmunity Centers of Excellence
Conditions:
Sjogren's Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody currently used to tr...
Detailed Description
SS is the second most common autoimmune disease; it is caused by immune cells attacking and destroying the glands that produce tears and saliva, and occurs more often in women than in men. Currently, ...
Eligibility Criteria
Inclusion
- Weighs at least 40 kg (88.2 lbs)
- Meets European criteria proposed by the American-European Consensus Group for primary Sjogren's syndrome
- Has 1 or more of the following symptoms of Sjogren's syndrome: fatigue; joint pain; peripheral neuropathy; interstitial lung disease; leukocytoclastic vasculitis; renal tubular acidosis; interstitial nephritis; severe parotid swelling; or other extraglandular manifestations causing organ system dysfunction
- Agrees to use acceptable methods of contraception during the study and for 12 months after the end of treatment
Exclusion
- Active infection
- Chronic or persistent infection which might be worsened by immunosuppressive treatment (e.g., HIV, hepatitis B or C, tuberculosis \[TB\])
- Known coronary artery disease, significant cardiac arrhythmias, or severe congestive heart failure (New York Heart Association class III or IV)
- Current use of anticoagulants
- Prior use of rituximab
- Cyclophosphamide treatment within 24 weeks prior to screening
- Certain medications that may cause dry mouth
- Cytotoxic therapy with azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 4 weeks prior to screening
- Etanercept within 4 weeks prior to screening
- Adalumimab within 8 weeks prior to screening
- Infliximab within 12 weeks prior to screening
- Prednisone at greater than 10 mg/day within 2 weeks prior to screening. Patients who have their steroid doses tapered to 10 mg/day or less within 2 weeks of screening are not excluded.
- Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus erythematosus, scleroderma, rheumatoid arthritis)
- History of alcohol or substance abuse
- History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity
- Known anaphylaxis to mouse-derived proteins
- History of head and neck radiation therapy
- History of sarcoidosis (inflammation of unknown cause occurring in the lymph nodes, lungs, liver, eyes, skin, or other tissues)
- History of graft-versus-host disease
- History of cancer. Patients who have had resected basal or major squamous cell carcinoma, cervical dysplasia, or in situ cervical cancer Grade I within the last 5 years prior to study entry are not excluded.
- History of positive PPD without documentation of treatment for TB infection or chemoprophylaxis for TB exposure
- Live vaccines within the 3 months prior to study entry
- Severe pulmonary disease. Patients who do not have undue fatigue or dyspnea following ordinary physical activity are not excluded.
- Psychiatric disorder precluding informed consent
- Inability or unwillingness to follow study requirements
- Any current condition or treatment that, in the opinion of the investigator, may interfere with the study
- Pregnancy
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00101829
Start Date
April 1 2004
End Date
August 1 2009
Last Update
October 20 2017
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6160