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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1
Department of Rheumatology, Tel Aviv Medical Center
Tel Aviv, Israel, 64239