Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Gaylis, Norman B., M.D. Ewa Olech, M.D. Genentech |
---|---|
Information provided by: | Gaylis, Norman B., M.D. |
ClinicalTrials.gov Identifier: | NCT00425932 |
The purpose of this study is to further investigate rituximab in the treatment of rheumatoid arthritis and to evaluate magnetic resonance imaging of the joints as a possible method to improve the evaluation of treatments.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Impact of Rituximab on Magnetic Resonance Imaging Evidence of Synovitis and Bone Lesions in Patients With Moderate or Severe Rheumatoid Arthritis |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Rituximab: Active Comparator |
Drug: Rituximab
1000 mg IV x 2, 2 weeks apart
|
Rituximab is a monoclonal antibody that has been approved for the treatment of non-Hodgkin's B cell lymphoma (a type of cancer) and for certain patients with rheumatoid arthritis (RA) by the Food and Drug Administration (FDA). To date, more than 1000 subjects with rheumatoid arthritis have received rituximab in clinical studies.
Magnetic resonance imaging (MRI) is a modern and sensitive method of looking at joints in people with rheumatoid arthritis. It uses a magnetic field to create an image. The MRI takes an image in 3 dimensions and this provides a better picture for a physician to see more details.
There are two treatment groups in this study with equal numbers of patients assigned to each group. All the patients will receive their baseline Methotrexate and two intravenous infusions 2 weeks apart of one of the following:
All the patients will have MRI of their dominant hand and wrist with and without gadolinium performed at baseline, 12, 24 and 48 weeks on 1.5 Tesla MRI . Some patients will also have additional MRI of the same hand and wrist without gadolinium at the same time points on 0.2 Tesla MRI. Comparison of the images from the two machines will be performed.
Various blood biomarkers will also be examined, compared between the 2 treatment groups and correlated with the MRI results.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Contact: Norman B Gaylis, MD | 305-652-6676 | drnbg@rheum-care.com |
Contact: Ewa Olech, MD | 405-271-7805 | ewa-olech@omrf.ouhsc.edu |
United States, Florida | |
Arhtritis & Rheumatic Disease Specialties | Not yet recruiting |
Miami, Florida, United States, 33180 | |
Contact: Joanne Sagliani, BS/CCRC 305-652-6676 drnbg@rheum-care.com | |
Principal Investigator: Norman B Gaylis, MD | |
Drs. Charles Kahn and Wayne Riskin | Not yet recruiting |
Hollywood, Florida, United States, 33021 | |
Contact: Joanne Sagliani, BS/CCRC 305-652-6676 drnbg@rheum-care.com | |
Sub-Investigator: Charles Kahn, MD | |
Sub-Investigator: Wayne Riskin, MD | |
United States, Oklahoma | |
Oklahoma Medical Research Foundation | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact: Angela Genovese, RN 405-271-8001 ext 34824 angela-genovese@omrf.ouhsc.edu | |
Contact: Fredonna Carthen (405) 271-8001 ext 34808 fredonna-carthen@omrf.ouhsc.edu | |
Principal Investigator: Ewa Olech, M.D. | |
Sub-Investigator: Joan T Merrill, MD | |
McBride Clinic Orthopedic Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73103 | |
Contact: Larry Willis, MD 405-232-0341 lwillis@mcbrideclinic.com | |
Sub-Investigator: Larry Willis, MD |
Principal Investigator: | Norman B Gaylis, MD | Arthritis & Rheumatic Disease Specialties |
Principal Investigator: | Ewa Olech, M.D. | Oklahoma Medical Research Foundation |
Responsible Party: | Arthritis and Rheumatic Disease Specialties ( Norman B. Gaylis, M.D. ) |
Study ID Numbers: | U3900s |
Study First Received: | January 22, 2007 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00425932 |
Health Authority: | United States: Food and Drug Administration |
Magnetic Resonance Imaging Rituximab Low Field MRI Biomarkers |
Autoimmune Diseases Musculoskeletal Diseases Rituximab Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Synovitis Rheumatic Diseases |
Immunologic Factors Immune System Diseases Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |