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.
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: * 1000 mg rituximab or * placebo. Patients outcomes will be compared between the 2 groups. After week 24 (open label phase), the patients will receive rituximab if rheumatoid arthritis remains active. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
At Week 24 or any time up to Week 48 if the Patient DAS 28 \> 2.6 patients will be retreated with 1000 mg IV at Day and Day 15.
Guillermo Valenzuela MD
Fort Lauderdale, Florida, United States
Drs. Charles Kahn and Wayne Riskin
Hollywood, Florida, United States
Arhtritis & Rheumatic Disease Specialties
Miami, Florida, United States
Arthritis and Rheumatology Clinics of Kansas
Wichita, Kansas, United States
The primary endpoint fo the trial is change in 1.5 Tesla MRI erosion score (RAMRIS system) from baseline to Week 24.
Time frame: 24 weeks
Change from Baseline in 1.5 Tesla MRI synovitis score (RAMRIS system) at Week 12.
Time frame: 12 weeks
Change from Baseline in 1.5 Tesla MRI bone edema and total score (RAMRIS system) at Week 24.
Time frame: 24 weeks
Change from Baseline in 1.5 Tesla MRI bone edema, bone erosion and total score (RAMRIS system) at Week 12 and Week 48.
Time frame: 12 and 48 weeks
Proportion of patients at Week 48 without new bone erosions on 1.5 Tesla MRI.
Time frame: 48 weeks
Change from baseline in total Genant modified Sharp score on conventional radiographs at Week 24 and 48.
Time frame: 24 and 48 weeks
Change in Disease Activity Score (DAS 28) from Baseline to Week 24 and 48.
Time frame: 24 and 48 weeks
ACR remission and responder rates (20%, 50%, &)%) at Week 24 and 48.
Time frame: 24 and 48 weeks
Change from Baseline in functional assessments according to the HAQ scores at 24 and 48 Weeks.
Time frame: 24 and 48 weeks
Difference between relative results from conventional high-field strength 1.5 Tesla MRI and 0.2 Tesla dedicated extremity MRI in detection and grading of bone erosions, bone edema, and synovitis at Baseline and in Week 12,24, and 48 (C-scan validation).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
McBride Clinic Orthopedic Center
Oklahoma City, Oklahoma, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Time frame: 12, 24 and 48 weeks