Rituximab for Anti-cytokine Autoantibody-Associated Diseases
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|ClinicalTrials.gov Identifier: NCT01842386|
Recruitment Status : Recruiting
First Posted : April 29, 2013
Last Update Posted : October 19, 2017
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Anticytokine Autoantibody-Associated Diseases Disseminated Non-Tuberculous Mycobacteria Chronic Mucocutaneous Candidiasis Pulmonary Alveolar Proteinosis (PAP)||Drug: Rituximab/Rituxan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rituximab (Anti-CD20) for the Treatment of Subjects With Anticytokine Autoantibody-Associated Diseases|
|Study Start Date :||April 25, 2013|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||January 1, 2025|
This is a Phase 1, single-arm, open label study.
Rituximab is a genetically engineered chimeric murine/human monoclonal antibody targeting the CD20 antigen expressed on the surface of normal and malignant B cells. It is an FDA-approved drug for the treatment of rheumatoid arthritis and non-Hodgkin's Lymphoma. We have received permission from the FDA to use rituximab for this study.
- The evaluation of adverse events to determine the safety and tolerability of rituximab in subjects with anticytokine autoantibody-associated diseases who are refractory to conventional treatment. [ Time Frame: At the conclusion of the study or if a serious adverse event occurs during the course of the study that may be related to the study drug. ]
- Evaluation of changes in autoantibody titers in response to rituximab treatment. [ Time Frame: At the conclusion of the study or if a serious adverse event occurs during the course of the study that may be related to the study drug. ]
- Assessment of the effects of rituximab on autoantibody-mediatedclinical disease. [ Time Frame: At the conclusion of the study or if a serious adverse event occurs during the course of the study that may be related to the study drug. ]
- The measurement of both qualitative and quantitative differences in antibody composition and immune function after treatment with rituximab. [ Time Frame: At the conclusion of the study or if a serious adverse event occurs during the course of the study that may be related to the study drug. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842386
|Contact: Pamela A Welch, R.N.||(301) firstname.lastname@example.org|
|Contact: Christa S Zerbe, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Christa S Zerbe, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|