Therapeutic drug monitoring in tocilizumab-treated rheumatoid arthritis patients: Pilot study of a double-blind randomised controlled trial
Phase 4
Recruiting
- Conditions
- rheumarheumatoid arthritis10003816
- Registration Number
- NL-OMON44574
- Lead Sponsor
- Amsterdam Rheumatology and immunology Center | Reade
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
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.
Exclusion Criteria
Scheduled surgery in the next 20 weeks or other preplanned reasons for treatment discontinuation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study outcome is the feasibility of the study logistics<br /><br><br /><br>This will be evaluated according to the following endpoints:<br /><br>- Percentage of patients completing 20-weeks follow-up. We accept a drop out of<br /><br>10%.<br /><br>- We only accept a few protocol deviations, when there are more than 3 protocol<br /><br>deviations, the protocol should be adjusted according to this deviations.<br /><br>- The opinion of approached and participating patients about the study<br /><br>protocol. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary study outcome is the feasibility of the dose reduction algorithme.<br /><br>The algorithm is feasible if 80% of the patients achieve serum concentration in<br /><br>the range of 4-6 mg/L and none of the patients has a drug concentration below 1<br /><br>mg/L. If between 50% and 80% of the patients achieve the targeted range, the<br /><br>algorithm must be adjusted before implementation in further studies. When less<br /><br>than 50% of the patients achieve the targeted drug concentration range, a new<br /><br>algorithm must be designed. </p><br>