TNFalfa Blocking Treatment of Spondylarthropathies

The purpose of the study is to establish a Danish cohort of spondylarthropathy (SpA) patients who are being treated with TNFalfa blockers. By following the TNFalfa blocking treated patients the researchers want to identify better biomarkers for disease activity and disease progression. In addition, the researchers want to identify predictors for disease progression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondylarthropathies Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age>18 years old
Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG) criteria
Sacroiliitis by X-ray or magnetic resonance imaging (MRI)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>3
No signs of tuberculosis (TB)
Sufficient contraception

Exclusion criteria

Wish of pregnancy or nursing
Previous treatment with TNFalfa blocker
Disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) later than 4 weeks before inclusion
Steroid treatment later than 4 weeks before inclusion
Immunosuppressing agents later than 4 weeks before inclusion
Severe infections within 3 months
HIV-infection
Active hepatitis B and C
Active or latent TB
Severe chronic diseases
Heart insufficiency (New York Heart Association [NYHA] 3 and 4)
Malignancy
Systemic lupus erythematosus (SLE) or SLE-like disease
Abuse of narcotics or alcohol
Major psychiatric disorders

Treatment and study plan

Infliximab

Drug

etanercept

Drug

Adalimumab

Drug

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies

Important dates

Study start: 2004
Study completion: 2007
First posted: Aug 23, 2005
Registry last updated: Apr 10, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed