Status:

COMPLETED

A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inad...

Eligibility Criteria

Inclusion

  • adult patients, \>=18 years of age;
  • active moderate or severe rheumatoid arthritis;
  • active disease for \>6 months;
  • inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

Exclusion

  • rheumatic autoimmune disease other than rheumatoid arthritis;
  • prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
  • major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.

Key Trial Info

Start Date :

May 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2010

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT00887341

Start Date

May 1 2009

End Date

December 1 2010

Last Update

October 22 2014

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Vitoria-Gasteiz, Alava, Spain, 01009

2

Villajoyosa, Alicante, Spain, 03570

3

Ávila, Avila, Spain, 05071

4

Menorca, Balearic Islands, Spain, 07701