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A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate

Phase 2
18 Years
65 Years
Not Enrolling
Rheumatoid Arthritis

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Trial Information

A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate

Inclusion Criteria:

- Diagnosis of RA for at least 6 months.

- Inadequate response to MTX

- Use of folate

- If female and of childbearing potential, have a negative serum pregnancy test within
8 weeks prior to first rituximab infusion

Exclusion Criteria:

- Diagnosis of juvenile idiopathic arthritis (also known as juvenile rheumatoid
arthritis) and/or RA before age 16

- Any surgical procedure, including bone/joint surgery or planned surgery within 8
weeks prior to screening or within 16 weeks of Week 1 (Day 1) visit

- Inflammatory arthritis other than RA (e.g., inflammatory bowel disease, systemic
lupus erythematosus (SLE), or psoriatic arthritis)

- Functional Class IV as defined by the American College of Rheumatology (ACR)
classification of functional status in RA

- Use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks
prior to randomization (8 weeks prior for infliximab, adalimumab, or leflunomide)

- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
of the investigational drug (whichever is longer)

- Previous treatment with Tysabri (natalizumab)

- Previous treatment with rituximab

- Previous treatment with any cell-depleting therapies, including investigational

- Treatment with IV &-globulin or Prosorba(R) Column within the previous 6 months

- Use of intra-articular or parenteral corticosteroids within 4 weeks prior to
screening visit

- Receipt of a vaccine within 4 weeks prior to Day 1 infusion

- History of severe allergic or anaphylactic reactions to humanized or murine
monoclonal antibodies

- Primary or secondary immunodeficiency (history of or active)

- Evidence of significant uncontrolled concomitant diseases such as cardiovascular
disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary
disease, including any pulmonary or other condition that would preclude subject
participation over the ensuing 2 years

- Known active bacterial, viral, fungal, mycobacterial, or other infection (including
tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
nail beds)

- History of recurrent significant infection or any significant episode of infection
requiring hospitalization or treatment with IV antibiotics within 4 weeks of
screening or oral antibiotics within 2 weeks prior to screening

- History of significant cytopenias or other bone marrow disorders

- History of cancer, including solid tumors and hematologic malignancies (except basal
cell and squamous cell carcinoma of the skin that have been excised and cured)

- Pregnant or nursing (breast feeding) women

- Lack of peripheral venous access

- Chronic daily use of narcotic analgesics

- History of alcohol, drug, or chemical abuse within 6 months prior to screening

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Either an Infection or a Grade III or IV Adverse Event (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTCAE], Version 3.0)

Outcome Description:

A Grade III Adverse Event (AE) is severe; defined as considerable interference with the subject's daily activities, medical intervention/therapy required and hospitalization possible. A Grade IV AE is life-threatening; defined as extreme limitation in activity, significant medical intervention/therapy required, hospitalization probable. Because of the small sample size and the small number of subjects who completed Week 104, the analysis were limited to descriptive statistics only.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

William Reiss, Pharm.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

February 2009

Related Keywords:

  • Rheumatoid Arthritis
  • Rituxan
  • RA
  • Arthritis
  • Arthritis, Rheumatoid