NCT00144651

Brief Summary

This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2 rheumatoid-arthritis

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

August 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

7.8 years

First QC Date

September 2, 2005

Last Update Submit

August 6, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • ACR 20% responder rate compared to the pre-treatment in the preceding study

    throughout study

  • Frequency and severity of adverse events and adverse drug reactions

    week0,week4,week8,week12,and LOBS

Secondary Outcomes (4)

  • Time course of DAS28,compared to the pre-treatment in the preceding study

    week 0,week 4,week 8,week 12, LOBS

  • Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study

    week 0,week 4,week 8,week 12, LOBS

  • ACR N AUC compared to the pre-treatment in the preceding study

    week 0,week 4,week 8,week 12, LOBS

  • Time course of the ACR core set variables compared to the pre-treatment in the preceding study

    week 0,week 4,week 8,week 12, LOBS

Study Arms (1)

1

EXPERIMENTAL
Drug: MRA(Tocilizumab)

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4 weeks for 1 year

1

Eligibility Criteria

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

You may qualify if:

  • Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
  • Patients confirmed to have shown the safety in the preceding study.

You may not qualify if:

  • Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
  • Patients who received any of the following treatments between the start of preceding study and the registration of this study.
  • Plasma exchange therapy
  • Surgical treatment (e.g., operation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Takahiro Kakehi

    Chugai Pharmaceutical

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

August 1, 2001

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

August 9, 2013

Record last verified: 2013-08