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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00133315 |
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Date of registration:
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22/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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TNFalfa Blocking Treatment of Spondylarthropathies
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Scientific title:
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TNFalfa Blocking Treatment of Spondylarthropathies - A Danish Multicenter Study of New Methods for Better Monitoring and Prognostifying Patients With Spondylarthropathies |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00133315 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Inge Juul Soerensen, MD, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hvidovre University Hospital, Dept. of Rheumatology |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Psoriatic Arthritis
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Spondylarthropathies
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Intervention(s)
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Drug: Adalimumab
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Drug: Etanercept
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Drug: Infliximab
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Secondary ID(s)
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232-001
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KF 02-050/04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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