Clinical trial NCT01347983: Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Official title: Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: RA
Lead sponsor: Chugai Pharma Taiwan
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of patients with an American College of Rheumatology 70 (ACR70) response
timeFrame: at week 24
Secondary outcomes:
measure: Proportion of patients with ACR50 response
timeFrame: at week 24
measure: Proportion of patients with ACR20 response
timeFrame: at week 24
measure: Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
timeFrame: at baseline and week 24
measure: Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
timeFrame: at baseline and week 24
measure: Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
timeFrame: at week 24
measure: Adverse event incidence
timeFrame: from baseline to week 24
measure: Mean change from baseline to evaluation visits in vital signs
timeFrame: from baseline to week 24
measure: Change in Electrocardiogram. From baseline to evaluation visits
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative hematological exam results.
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results.
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
timeFrame: from baseline to week 24
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital -Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
Study officials:
affiliation: Chugai Pharma Taiwan
name: Yoshiaki Someya
role: STUDY_CHAIR
References: