Biologicals and targeted synthetic Disease Modifying AntiRheumatic Drugs in inflammatory rheumatic diseases: observational daily clinical practice study The Reade Rheumatology Registry

Phase 4

Conditions: Rheumatic diseases
10023213

Registration Number: NL-OMON53055

Lead Sponsor: Jan van Breemen Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 2000

Inclusion Criteria

Patients with RA, PsA, AS or nrAxSpA who are treated with biologics or tsDMARDs
or in whom treatment with these agents is initiated. Plus an written informed
consent.

Exclusion Criteria

none

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy will be determined in comparison to baseline by comparing disease<br /><br>activity, radiological progression and functional capacity during follow-up.<br /><br>Safety will be determined by the occurrence of side effects. Changes in<br /><br>(bio)markers during treatment will be analyzed versus baseline.<br /><br>According to the rheumatic disease, the following study parameters are involved:<br /><br>RA: DAS28; followed by outcome measurements like EULAR response criteria, CDAI<br /><br>and SDAI criteria<br /><br>PsA: DAS28, PASI; followed by outcome measurements like EULAR response<br /><br>criteria, CDAI and SDAI criteria<br /><br>AS/nrAxSpA: BASDAI, BASMI en daaruit volgend onder andere de ASDAS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- adverse events<br /><br>- Swollen and painful joints (28 joint count)<br /><br>- ESR en/of CRP<br /><br>- lipid profiles<br /><br>- drug levels and antibodies<br /><br>- radiological progression<br /><br>- uveitis, psoriasis, IBD, tendinitis<br /><br>- improvement of functionality (BASMI) for AS<br /><br>- improvement of functionality (RAPID-3) for RA, PsA and AS<br /><br>- length, weight, blood pressure<br /><br>- Charlson Index<br /><br>- VAS Global and pain<br /><br>- LEI index<br /><br>- PASI</p><br>