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

NCT04731831 | Recruiting DMC

• 1 other identifier: N-20200063
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Outcome Measures

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)

  12 months

Secondary Outcomes (5)

• Immunogenesity

  12 months

• Drug koncentration

  12 months

• Concentration of markers of inflammation

  12 months

• Concentration of autoantibodies

  Day 1

• HLA-type

  Day 1

Study Arms (1)

Patient with arthritis starting infliximab or adalimumab

Patients with Rheumatoid Artritis, Psoriatic Arthritis, Anchylosing Spondylitis starting treament with infliximab or adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients \> 18 years
• Diagnosed with RA, PsA or AS.
• Starting treatment with infliximab or adalimumab.
• Co- treatment with csDMARD or glucocorticoid is acceptable.
• No new bDMARD is initiated at the time of sampling.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Department of rheumatology

Aalborg, 8000, Denmark

RECRUITING

Related Publications (29)

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Biospecimen

Retention: SAMPLES WITH DNA

EDTA Whole Blood EDTA-plasma, EDTA-buffy coat, serum.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Lene Dreyer, MD, Prof.

  Department of Clinical Medicine, Aalborg University and Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen B Lauridsen, MD

CONTACT

0045 097665595; kabula@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: February 1, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)