Urticaria Clinical Trial
Official title:
Phase I/II Open Label Evaluation of the Safety and Efficacy of Rituximab in Patients With Chronic Urticaria (The Rituximab Urticaria Study - "RUSTY")
Verified date | August 2015 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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 antihistamines.
Status | Terminated |
Enrollment | 15 |
Est. completion date | May 2007 |
Est. primary completion date | May 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Major Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University, Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Genentech, Inc. |
United States,
Edwards JC, Szczepanski L, Szechinski J, Filipowicz-Sosnowska A, Emery P, Close DR, Stevens RM, Shaw T. Efficacy of B-cell-targeted therapy with rituximab in patients with rheumatoid arthritis. N Engl J Med. 2004 Jun 17;350(25):2572-81. — View Citation
Grattan CE, Sabroe RA, Greaves MW. Chronic urticaria. J Am Acad Dermatol. 2002 May;46(5):645-57; quiz 657-60. Review. — View Citation
Kaplan AP. Clinical practice. Chronic urticaria and angioedema. N Engl J Med. 2002 Jan 17;346(3):175-9. Review. — View Citation
Leandro MJ, Edwards JC, Cambridge G, Ehrenstein MR, Isenberg DA. An open study of B lymphocyte depletion in systemic lupus erythematosus. Arthritis Rheum. 2002 Oct;46(10):2673-7. — View Citation
Looney RJ, Anolik JH, Campbell D, Felgar RE, Young F, Arend LJ, Sloand JA, Rosenblatt J, Sanz I. B cell depletion as a novel treatment for systemic lupus erythematosus: a phase I/II dose-escalation trial of rituximab. Arthritis Rheum. 2004 Aug;50(8):2580- — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of Rituximab infusions in this patient population | 1 year or time until reconstitution of B cells | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
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