A Study of Tocilizumab in Patients With Rheumatoid Arthritis

A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01187563

Enrollment

Registered

2010-08-24

Start date

2010-08-31

Completion date

2010-12-31

Last updated

2011-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, tocilizumab

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety (clinical and laboratory parameters)	Throughout the study until week 10	Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count

Secondary

Measure	Time frame	Description
Treatment emergent adverse events	Throughout the study until week 10	Post-baseline changes in vital signs, and hematological and biochemical parameters

Countries

United States

Outcome results