TNFalfa Blocking Treatment of Spondylarthropathies

Psoriatic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133315
• Other study ID #: 232-001
• Secondary ID: KF 02-050/04
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2005
• Last updated: April 9, 2007
• Start date: September 2004
• Est. completion date: April 2007

Study information

• Verified date: April 2007
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Spondylarthropathies
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Infliximab

• Etanercept

• Adalimumab

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	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

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark,