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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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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN73232918 |
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Date of registration:
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20/12/2005 |
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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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Primary prevention of rheumatoid arthritis
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Scientific title:
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Date of first enrolment:
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01/10/2005 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN73232918 |
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Study type:
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Interventional |
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Study design:
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Randomised, double blinded, placebo controlled, parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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D.
van Schaardenburg |
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Address:
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Jan van Breemen Instituut
Dr. Jan van Breemenstraat 2
1056 AB
Amsterdam
Netherlands |
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Telephone:
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+31 (0)20 5896589 |
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Email:
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d.v.schaardenburg@janvanbreemen.nl |
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Affiliation:
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 18 - 70 years for RF+, 18+ for aCCP
2. Twice increased Immunoglobulin M (IgM)-RF and/or aCCP with 4+ weeks interval
3. Human Leukocyte Antigen (HLA)-DR Shared Epitope (SE) positive
Exclusion criteria: Situations with possible false positive RF:
1. Auto-immune diseases
2. Active infection with hepatitis C or Ebstein Barr virus
3. Recent chemotherapy
4. Co-morbidity with decreased life expectancy
5. Corticosteroid use for another disease
6. Contra-indications for corticosteroids: diabetes mellitus, osteoporosis
7. Pregnancy or lactation
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid arthritis
Musculoskeletal Diseases
Rheumatoid arthritis
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Intervention(s)
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1 - 2 intramuscular injections with 100 mg dexamethason with 6 weeks interval (2nd injection with verum depends on response to first injection) or twice placebo.
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Primary Outcome(s)
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50% reduction of the concentration of the increased antibodies after 6 months compared to no treatment.
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Secondary Outcome(s)
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Frequency of rheumatoid arthritis after 5 years compared to no treatment.
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Source(s) of Monetary Support
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The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
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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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