Clinical Pharmacology Study of MRA in Patient With Rheuma... | NCT00144573

Studies
Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment

NCT00144573

Sponsor

Chugai Pharmaceutical

Status

Completed

Last Update Posted

Dec 15, 2008Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

MRA(Tocilizumab)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Sep 2, 2005

First Submission Date that Met QC Criteria

Sep 2, 2005

First Posted Date

Sep 5, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2008

Last Update Posted Date

Dec 15, 2008Estimated

Description Module

Brief Summary

This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Name	Type	Description	Arm Group Labels	Other Names
MRA(Tocilizumab)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
20% improvement based on the ACR criteria compared with the baseline value.		throughout study

Secondary Outcomes

Measure	Description	Time Frame
Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.		Week 0, Week 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
Patients with RA at least 6 months prior to enrollment
Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min

Exclusion criteria

Patients with Class IV Steinbrocker functional impairment at enrollment
Patients who are undergoing dialysis
Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Takahiro Kakehi	Chugai Pharmaceutical	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C502936	tocilizumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided