Anti-CD20 Antibody Therapy for Sjogren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00101829
• Date of registration: 13/01/2005
• Prospective Registration: No
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Anti-CD20 Antibody Therapy for Sjogren's Syndrome
• Scientific 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
• Date of first enrolment: April 2004
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00101829
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Philip L. Cohen, MD
• Affiliation: Rheumatology Division, University of Pennsylvania

• Name: E. William St. Clair, MD
• Affiliation: Division of Rheumatology and Immunology, Duke University Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: Rituximab

Primary Outcome(s)

Count of Participants with Rituximab Related Grade 3 or higher AEs [Time Frame: Throughout study]

Secondary ID(s)

DAIT ASJ01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Autoimmunity Centers of Excellence