TNFalfa Blocking Treatment of Spondylarthropathies

Phase 4

Completed

• Conditions: Spondylarthropathies; Ankylosing Spondylitis; Psoriatic Arthritis

• Registration Number: NCT00133315
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Status Verified: 2007-04
• Study Completion: 2007-04
• Last Update Submitted: 2007-04-09
• Last Update Posted: 2007-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (9)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte Hospital; 🇩🇰 Gentofte, Denmark

Glostrup Hospital; 🇩🇰 Glostrup, Denmark

Graasten Gighospital; 🇩🇰 Graasten, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Horsens Sygehus; 🇩🇰 Horsens, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark