Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
NCT ID: NCT00216177
Last Updated: 2009-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
112 participants
INTERVENTIONAL
2005-09-30
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Adalimumab
Humira
Infliximab
Remicade
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
* Fading clinical response to infliximab
* Negative pregnancy test (women with childbearing potential)
* Use of reliable method of contraception (women with childbearing potential)
* Informed consent
Exclusion Criteria
* Lack of co-operability
* Positive serology for hepatitis B or C
* History of positive HIV status
* History of TB or untreated latent TB
* Histoplasmosis or Listeriosis
* Pregnancy or breastfeeding
* Persistent or recurrent infections
* History of cancer
* Uncontrolled diabetes
* Ischaemic heart disease
* Congestive heart failure (NYHA 3-4)
* Active inflammatory bowel disease
* Recent stroke (within 3 months)
* History of or current inflammatory joint disease other than RA
* Previous diagnosis or signs of central nervous system demyelinating disease
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
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Hvidovre Hospital
Principal Investigators
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Henrik Skjodt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hvidovre University Hospital
Locations
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Hvidovre Hospital
Copenhagen, , Denmark
Bispebjerg Hospital
Copenhagen, , Denmark
Gentofte Amtssygehus
Copenhagen, , Denmark
Glostrup Hospital
Copenhagen, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Graasten Gigthospital
Gråsten, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EudraCT no: 2005-001633-14
Identifier Type: -
Identifier Source: secondary_id
Switch/HUM 05-001
Identifier Type: -
Identifier Source: secondary_id
232-003
Identifier Type: -
Identifier Source: org_study_id
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