Rheumatoid Arthritis
Conditions
Brief summary
This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in patients with active rheumatoid arthritis who have had an inadequate response to at least 1 DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
Interventions
DRUGrituximab [MabThera/Rituxan]
1000 mg iv Days 1 and 15
DRUGmethotrexate
10 - 25 mg/week
DRUGmethylprednisolone
iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-80 years of age; * rheumatoid arthritis after inadequate response to \>=1 DMARD treatment; * active disease; * DMARDs other than methotrexate withdrawn for at least 4 weeks prior to start of study treatment.
Exclusion criteria
* autoimmune disease other than rheumatoid arthritis; * bone/joint surgery within 8 weeks prior to screening, or joint surgery planned within 24 weeks of MabThera infusion; * concurrent treatment with any DMARD or antiTNF-alfa; * intra-articular or parenteral corticosteroids within 4 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 | Baseline, Week 24 | DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline, Week 24 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
Countries
Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab/Methylprednisolone/MTX Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Rituximab/Methylprednisolone/MTX |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 52.29 years STANDARD_DEVIATION 11.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment Serbia | 14 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 2 / 14 |
Outcome results
Primary
Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
Time frame: Baseline, Week 24
Population: Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab/Methylprednisolone/MTX | Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24 | 2.98 score on a scale | Standard Deviation 1.8 |
p-value: <0.00195% CI: [1.73, 4.22]t-test, 2 sided
Secondary
Health Assessment Questionnaire-Disability Index (HAQ-DI)
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline, Week 24
Population: PP Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab/Methylprednisolone/MTX | Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline | 1.91 score on a scale | Standard Deviation 0.687 |
| Rituximab/Methylprednisolone/MTX | Health Assessment Questionnaire-Disability Index (HAQ-DI) | Week 24 | 1.05 score on a scale | Standard Deviation 0.96 |
p-value: <0.001t-test, 2 sided