(Cost-)effectiveness of electronic drug monitoring feedback in order to decrease non-adherence in RA-patients starting with biological DMARD - A randomised clinical trial at Reade

Recruiting

Conditions: Rheumatoid Arthritis
10023213

Registration Number: NL-OMON42203

Lead Sponsor: Jan van Breemen Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 227

Inclusion Criteria

Diagnosed with RA (2010 ARA criteria or clinical judgment by a rheumatologist)
Initiating a new (subcutaneously administered) bDMARD
>18 years
Sufficient ability to understand Dutch
Be able to be followed for 12 months (life expectancy)

Exclusion Criteria

Large cognitive limitations
Assistance in taking drugs (e.g. home care)
Included in another randomised controlled trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure will be the difference in proportion of<br /><br>non-adherence patients (less than 80% medication adherence) after 1 year<br /><br>between the intervention group and in the usual care control group assessed<br /><br>with the validated compliance questionnaire on rheumatology (CQR) and pharmacy<br /><br>refill data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will be time to low disease activity and remission, serum<br /><br>trough levels (optional) and proportion of switching patients to another<br /><br>biological and mean disease activity after 1 year. Finally an economic<br /><br>evaluation of the possible added value of electronic drug monitor feedback<br /><br>compared with usual care will be done. </p><br>