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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00396812 |
Rheumatoid arthritis (RA) is a relatively common chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function that is estimated to affect 0.8% of the population. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. In addition, the safety and tolerability of rituximab in this population will be examined.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label, Single Arm, Single Center, Phase I/II Trial of Rituximab (a Monoclonal Antibody to CD20) for the Treatment of Early Rheumatoid Arthritis |
Estimated Enrollment: | 10 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive two intravenous infusions of rituximab given in an outpatient setting at study entry and Week 2. Throughout the study, participants will receive MTX, systemic corticosteroids, and folic acid.
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Drug: Rituximab
1000 mg intravenous infusion
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RA is characterized by persistent inflammation of peripheral joints, causing pain, stiffness, swelling, and warmth. RA is commonly managed by DMARDs initiated early in the disease process, before irreversible joint damage occurs. The most common DMARD prescribed in the United States is MTX; this drug is well tolerated and has better efficacy compared to other DMARDs, but is inadequate in providing lasting improvement in people with RA. In patients with an inadequate response to MTX alone, the use of biologic agents, including TNF-blocking agents in combination with MTX, has become a standard therapeutic approach.
Rituximab is a man-made antibody used to treat certain types of cancer. The drug blocks the CD20 antigen found on the surface of B cells and is known to deplete B cells when administered intravenously. Previous research suggests B-cell activity is important in pathogenesis of RA, so B-cell depletion may decrease inflammation and other symptoms of RA. Rituximab has recently been approved by the FDA for use in combination with MTX for treatment of patients with moderately to severely active RA who have had an inadequate response to TNF-blocking agents. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. Levels of B and T cells and other markers of disease activity will be monitored during the study. The safety and tolerability of rituximab in this DMARD-naive population will be examined.
This study will last about 2.5 years. All study participants will receive two intravenous infusions of rituximab given in an outpatient setting at study entry and Week 2. Throughout the study, participants will receive MTX, systemic corticosteroids, and folic acid. MTX dosing will be re-evaluated with disease activity scores every month until Month 6 and again at Months 8, 10, and 12. Systemic corticosteroid doses will be modified based on the participant's health while in the study. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) is permitted, but NSAID doses should not be changed during the study if at all possible. NSAIDs will not be provided by this study.
There will be a maximum of 2 screening visits before study treatment, a baseline visit, and 11 study visits. A physical exam, assessment for adverse events, and blood collection will occur at all study visits. Kidney and liver function tests and rheumatologic evaluations will occur at most study visits; participants will also be asked to complete a questionnaire on their health at most study visits. Arthroscopy (knee biopsy) on the more inflamed knee will occur at baseline and Month 3. Participants will be contacted by telephone the day after each arthroscopy and rituximab infusion.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruth Grosskreuz, MD | 303-724-7518 | Ruth.Grosskreuz@uchsc.edu |
United States, Colorado | |
University of Colorado Health Sciences Center | Recruiting |
Denver, Colorado, United States, 80262 | |
Contact: Ruth Grusskreuz, MD 303-724-7514 Ruth.Grusskreuz@uchsc.edu |
Study Chair: | Christopher Striebich, MD, PhD | Rheumatology Division, University of Colorado Health Sciences Center |
Principal Investigator: | Robert D. D'Ambrosia, MD | Department of Orthopedics, University of Colorado Health Sciences Center |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | DAIT ARA04 |
Study First Received: | November 6, 2006 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00396812 |
Health Authority: | United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Rituximab Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Immunoglobulins |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |