Status:
UNKNOWN
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
University Hospital, Gentofte, Copenhagen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimu...
Eligibility Criteria
Inclusion
- ACR criteria fulfilled,DAS28-3(CRP \> 3.2
- \> 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
- Age less than 18 years
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00216177
Start Date
September 1 2005
End Date
June 1 2009
Last Update
August 18 2009
Active Locations (6)
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1
Hvidovre Hospital
Copenhagen, Denmark, 2650
2
Bispebjerg Hospital
Copenhagen, Denmark
3
Gentofte Amtssygehus
Copenhagen, Denmark
4
Glostrup Hospital
Copenhagen, Denmark