Rheumatoid Arthritis
Conditions
Brief summary
This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.
Interventions
DRUGmethotrexate
stable dose
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks, 24 weeks
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \>/= 6 months duration * Active moderate to severe rheumatoid arthritis (DAS \>/= 3.2) * Swollen joint count (SJC) \>/= 6, tender joint count \>/= 8 * Synovitis in the dominant hand * Inadequate response to stable dose of a non-biological DMARD for at least 3 months * Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug * Patient on outpatient treatment
Exclusion criteria
* Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization * Rheumatic autoimmune disease other than rheumatoid arthritis * American College of Rheumatology (ACR) functional class IV * History of or current inflammatory joint disease other than rheumatoid arthritis * Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment * Intra-articular or parenteral corticosteroids within 6 weeks prior to study start * Inadequate hematologic, renal or liver function * Positive for hepatitis B, hepatitis C or HIV infection * Pregnant or lactating women * History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies * Current infections or history of recurrent infections * History of or currently active primary or acquired immunodeficiency * Active tuberculosis requiring treatment in the previous 3 years * Body weight \> 150 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale | from baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Ritchie articular index | from baseline to Week 24 |
| Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24 | Weeks 12 and 24 |
| Change in pain: Visual analogue scale (VAS) | from baseline to Week 24 |
| Change in disability: Stanford Health Assessment Questionnaire | from baseline to Week 24 |
| Radiological changes in the hand according to the modified Sharp scale | from baseline to Week 24 |
| Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR) | from baseline to Week 28 |
| Change in C-reactive protein | from baseline to Week 24 |
| Change in immunologic parameters: Rheumatic factor/anti-CCP | from baseline to Week 24 |
| Safety: Incidence of adverse events | approximately 2 years |
| Change in FACIT-fatigue questionnaire | from baseline to Week 24 |
Outcome results
None listed