NCT00216177
Unknown
Phase 4
Randomised, Multicenter, Open-label, Parallel-group Study Comparing Adalimumab 40 mg s.c. Eow Versus Infliximab 3 mg/kg i.v. Every 6 Weeks in Rheumatoid Arthritis Patients With Unsustainable Clinical Response to Infliximab 3 mg/kg Every 8 Weeks
ConditionsRheumatoid Arthritis
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 112
- Locations
- 6
- Primary Endpoint
- Proportion of patients achieving combined good or moderate EULAR responses at week 24
- Last Updated
- 16 years ago
Overview
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 adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Proportion of patients achieving combined good or moderate EULAR responses at week 24
Time Frame: six months
Secondary Outcomes
- ACR20/50/70 response at week 2, 6, 12, 18 and 24(six months)
Study Sites (6)
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