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Protocol Details

Rituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated Diseases

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Pulmonary Alveolar Proteinosis;
Mucocutaneous Candidiasis;

Recruitment Keyword(s)



Pulmonary Alveolar Proteinosis (PAP);
Severe Mucocutaneous Candidiasis

Investigational Drug(s)


Investigational Device(s)



Drug: Rituximab

Supporting Site

National Institute of Allergy and Infectious Diseases


- Healthy people have white blood cells that protect them against bacteria, viruses, and fungi. However, some people have diseases which cause the body to make white blood cells that do not work properly. These white blood cells can attack the body s own proteins. These types of diseases are called anti-cytokine autoantibody-associated diseases. They can cause severe illnesses and even death. They are also difficult to treat with standard drugs.

- Rituximab is a drug used to treat rheumatoid arthritis. It attacks white blood cells that do not work properly. Currently, it is not approved for treating anti-cytokine autoantibody-associated diseases. However, researchers think that it may be able to help treat people with these immune diseases.


- To see if rituximab is a safe and effective treatment for anti-cytokine autoantibody-associated diseases.


- Individuals at least 18 years of age who have anti-cytokine autoantibody-associated diseases.

- Participants must also be enrolled in a related immune disorder study at the National Institutes of Health.


- The study will last 24 months. Participants will take rituximab for 6 months and have follow-up visits for the remaining 18 months.

- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Other samples will be collected as needed if participants currently have an infection.

- Participants will enter the hospital for 1 week at the start of treatment. They will have four doses of rituximab given 2 days apart. This first treatment will be monitored with frequent blood tests.

- Over the next 6 months, participants will have four more doses of rituximab given about 1 month apart. Treatment will be monitored with frequent blood tests and sample collections as needed.

- There will be four follow-up study visits at 3, 6, 12, and 18 months after the last dose of rituximab.

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Subjects (greater than or equal to 18 years of age) are eligible if they meet the following criteria:

1. Currently enrolled in one of the following protocols: 95-I-0066, 07-I-0033, 01-I-0202, or 93-I-0119.

2. Presence of anticytokine autoantibodies in serum or plasma, along with the anticipated clinical consequences of the identified anticytokine autoantibody including, but not limited to:

- Anti-IFN- >= autoantibodies and disseminated NTM.

- Anti-IL-17 autoantibodies and CMC.

- Anti-GM-CSF autoantibodies and PAP or cryptococcosis.

3. Progression of anticytokine autoantibody-associated diseases despite conventional therapy, including, but not limited to:

- Antimycobacterials for disseminated NTM.

- Antifungals for mucocutaneous candidiasis or cryptococcosis.

- Subcutaneous or inhaled GM-CSF and/or whole lung lavage for PAP.

4. For ongoing autoantibody-associated infection, stable, optimized antibiotic regimen for at least 1 month prior to initiation of rituximab and ability to continue these antibiotics throughout treatment with rituximab.

5. Willingness to comply with study medication, visits, and procedures, as deemed necessary by the study investigator.

6. Willingness to have samples stored for future research and genetic testing.

7. Willingness to be hospitalized for the inpatient visits (initial doese on day 1 and day 15 will occur in the inpatient unit.

8. Negative serum pregnancy test result for women of childbearing potential.

- Women of childbearing potential and men are eligible if they agree to postpone conception for 18 months following rituximab therapy. They must agree to use 2 adequate methods of contraception, such as:

- Hormonal contraception.

- Male or female condoms with or without a spermicide, diaphragm or cervical cap with a spermicide, or intrauterine device.

- Sterilization of either partner.


Subjects who meet the following criteria are not eligible to enter the study:

1. HIV seropositivity.

2. Active underlying malignancy, except thymoma and basal and squamous cell carcinoma.

3. Immunomodulatory or immunosuppressive therapy, including:

- Corticosteroids at a dose equivalent to greater than or equal to 15 mg of prednisone/day at any time during the month immediately prior to enrollment.

- History of using biologic agents or any other systemic immune-suppressive or immunomodulatory agents within the past year.

4. Use of another investigational study agent within 8 weeks of enrollment.

5. Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins or any component of the study medication.

6. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.

7. Evidence of significant uncontrolled concomitant diseases, such as cardiovascular disease, or nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders.

8. Diagnosis of an unrelated underlying immunodeficiency.

9. Hepatitis B (subjects with hepatitis C are eligible to enter the study).

10. Live vaccines within 1 month prior to receiving the study drug.

11. Unsuitable participation as judged by the principal investigator.

12. History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured and thymoma).

13. History of alcohol, drug, or chemical abuse within 6 months prior to screening.

14. Poor peripheral venous access.

15. Intolerance or contraindications to oral or IV corticosteroids.

16. Screening laboratory values:

- Serum creatinine >1.4 mg/dL for women and >1.6 mg/dL for men.

- Platelet count <100,000/ L.

- Absolute neutrophil count <1500 cells/ L.

- IgG <5.65 times 10(-2) mg/dL or IgM <0.55 times 10(-2) mg/dL.

17. Breastfeeding.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Christa S. Zerbe, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 594-5932

Christine J. Lafeer, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 3
Room 1W23
3 Center Drive
Bethesda, Maryland 20892
(301) 761-6902

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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