Rheumatoid Arthritis (RA)
Conditions
Brief summary
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.
Interventions
DRUGTocilizumab + methotrexate(MTX)
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
DRUGTocilizumab placebo + methotrexate(MTX)
Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week
Sponsors
Chugai Pharma Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA. * Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose. * Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline. * C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.
Exclusion criteria
* Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment. * Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA. * Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care). * Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them. * Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an American College of Rheumatology 20(ACR20) response | at baseline and week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28) | at baseline and week 24 |
| Proportion of patients achieving DAS28 remission (DAS28 < 2.6) | at week 24 |
| Adverse event incidence | from baseline to week 24 |
| Mean change from baseline to evaluation visits in vital signs | from baseline to week 24 |
| Proportion of patients with ACR50 response | at baseline and week 24 |
| Result of Electrocardiogram. From baseline to evaluation visits | from baseline to week 24 |
| Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively | at baseline and week 24 |
| Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts). | from baseline to week 24 |
| Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.). | from baseline to week 24 |
| Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results. | from baseline to week 24 |
| Mean change from baseline visit to evaluation visits in quantitative urinalysis results. | from baseline to week 24 |
| Proportion of patients with ACR70 response | at baseline and week 24 |
Countries
Taiwan
Outcome results
None listed