Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis (RA)
- Interventions
- Registration Number
- NCT01258712
- Lead Sponsor
- Chugai Pharma Taiwan
- Brief Summary
This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Tocilizumab + methotrexate(MTX) - 2 Tocilizumab placebo + methotrexate(MTX) -
- Primary Outcome Measures
Name Time Method Proportion of patients with an American College of Rheumatology 20(ACR20) response at baseline and week 24
- Secondary Outcome Measures
Name Time Method Proportion of patients with ACR50 response at baseline and week 24 Proportion of patients with ACR70 response at baseline and 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 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 Result of Electrocardiogram. From baseline to evaluation visits from baseline to 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
Trial Locations
- Locations (12)
Chang Gung Memorial Hospital -Kaohsiung
🇨🇳Kaohsiung, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Cathay General Hospital
🇨🇳Taipei, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
🇨🇳Taoyuan, Taiwan
Buddhist Dalin Tzu Chi General Hospital
🇨🇳Chiayi, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan