Status:

UNKNOWN

Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis

Lead Sponsor:

Tel-Aviv Sourasky Medical Center

Collaborating Sponsors:

Amsterdam Rheumatology and Immunology Center

Conditions:

Rheumatoid Arthritis

Tocilizumab

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Rationale: A wide range of serum trough concentrations is observed in tocilizumab-treated rheumatoid arthritis (RA) patients, while 1 mg/L tocilizumab is sufficient to block systemic interleukin-6 rec...

Detailed Description

INTRODUCTION AND RATIONALE Rheumatoid arthritis (RA) is a chronic inflammatory disease with a symmetric polyarthritis. One of the cytokines playing a role in RA is interleukin-6 (IL-6)(1;2). Tocilizum...

Eligibility Criteria

Inclusion

  • RA according to the ACR 1987 or 2010 criteria;
  • Current use of tocilizumab IV, with a consistent interval of 4 weeks for at least 24 weeks.
  • 18 years of age and older.

Exclusion

  • A potential subject will be excluded from participation in case of a scheduled surgery in the next 20 weeks or other preplanned reasons for treatment discontinuation.
  • Children, pregnant women and individuals with a lack of judgement.

Key Trial Info

Start Date :

December 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2019

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT03781310

Start Date

December 1 2018

End Date

December 1 2019

Last Update

December 26 2018

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Rheumatology, Tel Aviv Medical Center

Tel Aviv, Israel, 64239