Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

MRA (Tocilizumab)

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety. In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study. Exclusion criteria Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Have not been registered by 3 months after the full code-breaking of the preceding study Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria

Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions

Pharmacokinetics of the serum MRA concentration

Secondary Outcome Measures

Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set

Full Information

NCT ID

NCT00144534

First Posted

September 2, 2005

Last Updated

December 21, 2009

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00144534

Brief Title

Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

Official Title

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

5. Study Description

Brief Summary

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

MRA (Tocilizumab)

Intervention Description

8mg/kg/4 weeks

Primary Outcome Measure Information:

Title

Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria

Time Frame

throughout study

Title

Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions

Time Frame

throughout study

Title

Pharmacokinetics of the serum MRA concentration

Time Frame

0W,4W,8W,12W,LOBS

Secondary Outcome Measure Information:

Title

Efficacy:time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set

Time Frame

0W,4W,8W,12W,LOBS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety. In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study. Exclusion criteria Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug Have not been registered by 3 months after the full code-breaking of the preceding study Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takahiro Kakehi

Organizational Affiliation

Chugai Pharmaceutical

Official's Role

Study Director

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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