NCT01347983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
Completed

Started May 2011

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

May 3, 2011

Last Update Submit

April 3, 2013

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with an American College of Rheumatology 70 (ACR70) response

    at week 24

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Interventions

Tocilizumab+Methotrexate(MTX)DRUG

Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan

Location

Chang Gung Memorial Hospital -Kaohsiung

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Cathay General Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yoshiaki Someya

    Chugai Pharma Taiwan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2011

First Posted

May 5, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2013

Study Completion

April 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

TW(12)