A Study of Tocilizumab in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187563
• Other study ID #: 0000-RA-1008
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: October 12, 2011
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: October 2011
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (clinical and laboratory parameters)	Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count	Throughout the study until week 10	Yes
Secondary	Treatment emergent adverse events	Post-baseline changes in vital signs, and hematological and biochemical parameters	Throughout the study until week 10	Yes