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Anti-CD20 Antibody Therapy for Sjogren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101829
Recruitment Status : Completed
First Posted : January 14, 2005
Last Update Posted : October 20, 2017
Autoimmunity Centers of Excellence
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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 treat some kinds of lymphoma. Rituximab may also help people with SS, a disease of the immune system. However, the safety of rituximab in SS patients must first be established.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: Rituximab Phase 1

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, there are no established disease-modifying treatments for SS. Traditional treatment strategies for SS primarily address dryness symptoms. Rituximab targets the CD20 antigen on the surface of B cells, and was approved in 1997 for the treatment of patients with low-grade or follicular B-cell non-Hodgkin's lymphoma. In a small study, rituximab was also shown to relieve the symptoms of rheumatoid arthritis. Because SS is associated with the development of B cell-related cancers and rituximab has the potential to treat autoimmune disease, rituximab may alleviate the symptoms of SS. This study will evaluate the safety of rituximab in people with SS.

This study will last 1 year. At 4 and 2 weeks before the start of the study, patients will undergo medical and medication history assessment, a physical exam, blood and urine collection, rheumatologic evaluation, an eye exam, and salivary gland tests. The screening visit 4 weeks before study start will also include an electrocardiogram (ECG), a chest x-ray, and a tuberculosis exam. Patients will receive IV rituximab at study entry and at Week 2; blood collection will occur prior to infusion and post-infusion for pharmacokinetics studies. There will be 6 follow-up study visits that will occur at Weeks 4, 8, 14, 26, 30, and 52. Blood and urine collection; a physical exam; rheumatologic evaluation; and eye, skin, and salivary gland tests will occur at selected study visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's Syndrome
Study Start Date : April 2004
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab Treatment
Participants will receive rituximab at study entry and at Week 2
Drug: Rituximab
1000 mg intravenous infusion
Other Name: Rituxan

Primary Outcome Measures :
  1. Count of Participants with Rituximab Related Grade 3 or higher AEs [ Time Frame: Throughout study ]
    The study site will grade the severity of adverse events (AEs) experienced by the study participants according to the criteria set forth in the National Cancer Institute's Common Toxicity Criteria for Adverse Events Version 3.0 (published June 10, 2003).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101829

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6160
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Autoimmunity Centers of Excellence
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Principal Investigator: Philip L. Cohen, MD Rheumatology Division, University of Pennsylvania
Principal Investigator: E. William St. Clair, MD Division of Rheumatology and Immunology, Duke University Medical Center
Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the site
Identifier: SDY961
ImmPort study identifier is SDY961
Study Protocol  This link exits the site
Identifier: SDY961
ImmPort study identifier is SDY961

Publications of Results:
Other Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00101829    
Other Study ID Numbers: DAIT ASJ01
First Posted: January 14, 2005    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Autoimmune Diseases
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents