Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Study Overview
=================
Brief Summary
-----------------
24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.

Official Title
-----------------
Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Tocilizumab+Methotrexate(MTX)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW). Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tocilizumab+Methotrexate(MTX)|Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with an American College of Rheumatology 70 (ACR70) response |  | at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ACR50 response |  | at week 24 | 
| Proportion of patients with ACR20 response |  | at 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 | 
| Change in Electrocardiogram. From baseline to evaluation visits |  | from baseline to week 24 | 
| Mean change from baseline visit to evaluation visits in quantitative hematological exam results. |  | from baseline to week 24 | 
| Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results. |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RA