NCT00144573

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2005

Shorter than P25 for not_applicable 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

January 1, 2005

Completed
8 months 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
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

December 15, 2008

Status Verified

December 1, 2008

Enrollment Period

9 months

First QC Date

September 2, 2005

Last Update Submit

December 11, 2008

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 20% improvement based on the ACR criteria compared with the baseline value.

    throughout study

Secondary Outcomes (1)

  • 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

Interventions

MRA(Tocilizumab)DRUG

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

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
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

January 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

December 15, 2008

Record last verified: 2008-12