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TNFalfa Blocking Treatment of Spondylarthropathies

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00133315
Enrollment
50
Registered
2005-08-23
Start date
2004-09-30
Completion date
2007-04-30
Last updated
2007-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Psoriatic Arthritis, Spondylarthropathies

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.

Interventions

DRUGInfliximab
DRUGEtanercept
DRUGAdalimumab

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026