Rheumatoid Arthritis
Conditions
Keywords
RA, Arthritis
Brief summary
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.
Interventions
DRUGInfliximab
Intravenous repeating dose
DRUGMethotrexate
Oral or parenteral repeating dose
DRUGMethylprednisolone
Intravenous repeating dose
DRUGOcrelizumab
Intravenous repeating dose
DRUGPlacebo
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years * Current treatment for RA on an outpatient basis * Active disease * Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week. * Considered by Investigator to be a primary non-responder to their first anti-TNFα treatment for efficacy reasons
Exclusion criteria
* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA * History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome) * Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab * Treatment with more than one prior anti-TNFα therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in DAS28(ESR) at Week 20 | Week 20 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Clinical Response of 50% According to ACR Criteria | Baseline up to 30 months |
| Percentage of Participants With Clinical Response of 70% According to ACR Criteria | Baseline up to 30 months |
| European League Against Rheumatism (EULAR) Response Rates | Baseline up to 30 months |
| Percentage of Participants With Clinical Response of 20% According to ACR Criteria | Baseline up to 30 months |
| Change in Fatigue Visual Analog Scale Score (VAS) | Baseline up to 30 months |
| Percentage of Participants With Adverse Events (AEs) | Baseline up to 30 months |
| Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | Baseline up to 30 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ocrelizumab 200mg Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. | 15 |
| Infliximab 5mg/kg Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. | 13 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double-Blind TX Period | Adverse Event | 0 | 1 |
| Double-Blind TX Period | Other reasons outside Sponsor decision | 1 | 1 |
| Double-Blind TX Period | Sponsor decision to terminate study | 1 | 1 |
| Open Label Ocrelizumab Treatment Period | Sponsor decision to terminate study | 9 | 4 |
| Study Period + 48 Weeks of Follow-up | Other reasons outside Sponsor decision | 6 | 2 |
| Study Period + 48 Weeks of Follow-up | Sponsor decision to terminate study | 3 | 7 |
Baseline characteristics
| Characteristic | Infliximab 5mg/kg | Total | Ocrelizumab 200mg |
|---|---|---|---|
| Age, Continuous | 54.2 Years STANDARD_DEVIATION 15.2 | 53.83 Years STANDARD_DEVIATION 13.97 | 53.5 Years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 26 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 3 Participants | 12 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 13 |
| other Total, other adverse events | 15 / 19 | 10 / 13 |
| serious Total, serious adverse events | 2 / 19 | 0 / 13 |
Outcome results
Primary
Change From Baseline in DAS28(ESR) at Week 20
Time frame: Week 20
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
Change in Fatigue Visual Analog Scale Score (VAS)
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
European League Against Rheumatism (EULAR) Response Rates
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to 30 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocrelizumab 200mg | Percentage of Participants With Adverse Events (AEs) | 78.9 Percentage of Participants |
| Infliximab 5mg/kg | Percentage of Participants With Adverse Events (AEs) | 76.9 Percentage of Participants |
Secondary
Percentage of Participants With Clinical Response of 20% According to ACR Criteria
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
Percentage of Participants With Clinical Response of 50% According to ACR Criteria
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.
Secondary
Percentage of Participants With Clinical Response of 70% According to ACR Criteria
Time frame: Baseline up to 30 months
Population: The study was terminated before data for the primary and secondary efficacy endpoints were collected so no data was collected for these efficacy endpoints.