MedTrace Logo

Rituximab for Anti-cytokine Autoantibody-Associated Diseases

NCT01842386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Pulmonary Alveolar Proteinosis (PAP)
  • Severe Mucocutaneous Candidiasis

Interventions

DRUG

Rituximab

Subjects will receive intravenous (IV) infusions of rituximab 1 gram on days 1 and 15, and subsequently if indicated up to once a month for 5 months (+/-5 days for each visit) starting approximately on day 42. Subjects whose infections respond positively to the treatment but then relapse may be offered additional treatment.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Christa S Zerbe, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-29
Primary Completion
2021-05-06
Completion
2021-05-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01842386 on ClinicalTrials.gov