Safety Study of Rituximab (Rituxan®) in Chronic Urticaria

NCT00216762 | Terminated Phase 1 DMC

• 1 other identifier: NA_00000857
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 antihistamines.

Conditions

Urticaria

Keywords

Urticaria; Hives

Outcome Measures

Primary Outcomes (1)

• Safety of Rituximab infusions in this patient population

  1 year or time until reconstitution of B cells

Interventions

Rituximab DRUG

Rituxan ® 1000 mg IV x 2 infusions, 2 weeks apart

Also known as: Rituxan ®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Johns Hopkins University, Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (5)

• Kaplan AP. Clinical practice. Chronic urticaria and angioedema. N Engl J Med. 2002 Jan 17;346(3):175-9. doi: 10.1056/NEJMcp011186. No abstract available.

  PMID: 11796852 BACKGROUND

• Grattan CE, Sabroe RA, Greaves MW. Chronic urticaria. J Am Acad Dermatol. 2002 May;46(5):645-57; quiz 657-60. doi: 10.1067/mjd.2002.122759.

  PMID: 12004303 BACKGROUND

• 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):2580-9. doi: 10.1002/art.20430.

  PMID: 15334472 RESULT

• 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. doi: 10.1056/NEJMoa032534.

  PMID: 15201414 RESULT

• 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. doi: 10.1002/art.10541.

  PMID: 12384926 RESULT

MeSH Terms

Conditions

Urticaria

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clifton O. Bingham, III, MD

  Johns Hopkins University, Divisions of Rheumatology and Allergy and Clinical Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: January 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

US (1)