Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Immune System Diseases [C20]; Rheumatoid arthritis

• Registration Number: EUCTR2018-004605-57-NL
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-24
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 98

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Rheumatoid arthritis according to the ACR 1987 or 2010 criteria;
-Current use of subcutaneous tocilizumab 162 mg weekly, for at least the last 6 months;
-The treating rheumatologist is convinced of the benefit of tocilizumab continuation;
-No changes in the treatment with glucocorticoids and DMARDs such as methotrexate in the past three months;
-Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-A scheduled surgery in the next 12 months or other pre-planned reasons for treatment discontinuation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified