CompletedPhase 1

Rituximab for Anti-cytokine Autoantibody-Associated Diseases

United States7 participantsStarted 2014-04-29

Plain-language summary

Background: * 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. Objectives: \- To see if rituximab is a safe and effective treatment for anti-cytokine autoantibody-associated diseases. Eligibility: * 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. Design: * 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Currently enrolled in one of the following protocols: 95-I-0066, 07-I-0033, 01-I-0202, or 93-I-0119.
✓. Presence of anticytokine autoantibodies in serum or plasma, along with the anticipated clinical consequences of the identified anticytokine autoantibody including, but not limited to:
✓. Progression of anticytokine autoantibody-associated diseases despite conventional therapy, including, but not limited to:
✓. 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.
✓. Willingness to comply with study medication, visits, and procedures, as deemed necessary by the study investigator.
✓. Willingness to have samples stored for future research and genetic testing.
✓. Willingness to be hospitalized for the inpatient visits (initial doese on day 1 and day 15 will occur in the inpatient unit.
✓. Negative serum pregnancy test result for women of childbearing potential.

Exclusion criteria

What they're measuring

safe and tolerable administration of rituximab in subjects with anticytokine autoantibody-associated diseases who are refractory to conventional treatment

Timeframe: at study end

Trial details

NCT IDNCT01842386

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2021-05-06

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