TNFalfa Blocking Treatment of Spondylarthropathies

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Spondylarthropathies; Psoriatic Arthritis; Ankylosing Spondylitis

Treatments: Drug: Etanercept; Drug: Adalimumab; Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00133315

232-001

KF 02-050/04

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)