A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-12-31

Brief Summary

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This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Detailed Description

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This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age
* Moderately to severely active rheumatoid arthritis
* Inadequate response to previous treatment with an anti-TNF agent
* Receiving methotrexate for at least 12 wks before study

Exclusion Criteria

* Previous treatment with tocilizumab
* Previous treatment with other IL-6 receptor inhibitors
* Treatment with corticosteroids (oral prednisone \>10 mg/day or equivalent) within 4 wks
* Conditions noted in the tocilizumab prescribing information

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Worcester, Massachusetts, United States

Site Status

Duncansville, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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0000-RA-1008

Identifier Type: -

Identifier Source: org_study_id