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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00133315
Date of registration: 22/08/2005
Prospective Registration: No
Primary sponsor: Hvidovre University Hospital
Public title: TNFalfa Blocking Treatment of Spondylarthropathies
Scientific title: TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies
Date of first enrolment: September 2004
Target sample size: 50
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Name:     Inge Juul Soerensen, MD, Ph.D
Affiliation:  Hvidovre University Hospital, Dept. of Rheumatology
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age>18 years old

- Spondylarthropathies according to the European Spondylarthropathy Study Group (ESSG)

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Psoriatic Arthritis
Drug: Adalimumab
Drug: Etanercept
Drug: Infliximab
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
KF 02-050/04
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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