Rheumatoid Arthritis
Conditions
Keywords
active disease despite concomitant methotrexate
Brief summary
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.
Detailed description
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.
Interventions
DRUGrituximab
treatment with rituximab
Sponsors
Genentech, Inc.
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Active rheumatoid arthritis * Use of concomitant methotrexate
Exclusion criteria
* Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate * Serious medical conditions that would preclude the use of the treating agent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American College of Rheumatology (ACR) 20 at Week 12 | 0 and 12 weeks | ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ritxumab Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14. | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Ritxumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 24 |
| serious Total, serious adverse events | 2 / 24 |
Outcome results
Primary
American College of Rheumatology (ACR) 20 at Week 12
ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).
Time frame: 0 and 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ritxumab | American College of Rheumatology (ACR) 20 at Week 12 | 12 participants |