Status:
TERMINATED
Safety Study of Rituximab (Rituxan®) in Chronic Urticaria
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Urticaria
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is being done to find out if a drug called Rituxan (Rituximab) is safe and effective in treating people with chronic urticaria (hives) with persistent symptoms in spite of taking antihistam...
Detailed Description
Rituximab (Rituxan®) is a recombinant chimeric monoclonal antibody that binds to a molecule (CD20) that is present on the surface of B lymphocytes. The product is approved for the treatment of non-Hod...
Eligibility Criteria
Inclusion
- Major
- Chronic urticaria defined as symptoms \>50% of the days or 3 days per week for more than 12 weeks
- Previous requirement for sustained or recurrent use of corticosteroids OR requirement for immunomodulatory treatment for urticaria (eg hydroxychloroquine, sulfasalazine, dapsone, cyclosporine, IVIg, etc) OR ongoing symptoms for at least 6 months duration with failure to respond at least maximally approved dosages of 2 different antihistamine therapies
- Chronic therapy with stable doses of antihistamines for at least 4 weeks. Patients may be taking more than one antihistamine or be taking combinations of antihistamines and leukotriene receptor antagonists
- High baseline score for pruritis (at least 2 on a 3 point scale)
- No underlying etiology clearly defined for urticaria
- Evidence of underlying autoimmunity as evidenced by clinical and laboratory criteria
- Concomitant use of hydroxychloroquine, sulfasalazine, or dapsone permitted if doses stable for at least 12 weeks
- Negative serum pregnancy test (for women of child-bearing age)
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment.
- No planned elective surgical procedures for at least 6 months
- Major
Exclusion
- Concomitant use of corticosteroids
- Current use of immunosuppressive medication (cyclosporine, IVIg, methotrexate, cyclophosphamide). Any such medication will be discontinued for at least 6 weeks before screening.
- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
- Receipt of a live vaccine within 4 weeks prior to randomization
- Previous treatment with Rituximab (MabThera® / Rituxan®)
- Prior antibody therapy
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Known history of HIV seropositivity (testing will be performed at screening)
- History of Hepatitis B and/or Hepatitis C (Hep BsAg and Hep C Ab will be obtained at screening)
- History of recurrent significant infection or history of recurrent bacterial infections
- Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds)
- Any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
- Known immunodeficiency syndrome, hypogammaglobulinemia, etc.
- Systemic lupus erythematosus
- Pregnancy (a negative serum pregnancy test will be performed for all women of childbearing potential within 7 days of treatment) or lactation
- Malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- Atopic dermatitis
- Clinically relevant medical conditions (cardiovascular including poorly controlled hypertension or coronary artery disease, pulmonary, metabolic, renal, hepatic, psychiatric) or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Plans or need to receive live viral vaccination over course of the study (e.g. Flu-Mist TM)
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00216762
Start Date
January 1 2006
End Date
May 1 2007
Last Update
September 2 2015
Active Locations (1)
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1
Johns Hopkins University, Bayview Medical Center
Baltimore, Maryland, United States, 21224