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Characterization of Immunogenicity of TNF Inhibitors in Arthritis Patients With Poorer Treatment Response.

ConditionsArthritis, RheumatoidArthritis, PsoriaticSpondylitis, Ankylosing
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAalborg University Hospital

About this trial

The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years

Diagnosed with RA, PsA or AS.

Starting treatment with infliximab or adalimumab.

Co- treatment with csDMARD or glucocorticoid is acceptable.

Disqualifiers

None

Trial population

Patients at department of Rheumatology in Aalborg Universityhospital, Denmark. Other sites in Jutland, Denmark may be inkluded later.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Patient with arthritis starting infliximab or adalimumab

Trial outcomes

Primary outcomes

1

Treatment response

Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response. * Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP) * Disease Activity in Psoriasis Arthritis (DAPSA) * Ankylosing Spondylitis Activity Score (ASDAS) * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) * Bath Ankylosin Spondylitis Functional Index (BASFI)

Time frame
12 months

Secondary outcomes

1

Immunogenesity

Antibodies directed against infliximab or adalimumab. Concentration of anti-drug-antibodies

Time frame
12 months
2

Drug koncentration

Plasma koncentration of infliximab or adalimumab

Time frame
12 months
3

Concentration of markers of inflammation

C-reactive protein (CRP), IL1, .

Time frame
12 months
4

Concentration of autoantibodies

ANA, ACPA, IgM-RF

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University Hospital

Lead sponsor

Source ClinicalTrials.gov
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