Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hvidovre University Hospital
• Collaborator: University Hospital, Gentofte, Copenhagen
• Treatments: Adalimumab; Infliximab

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

• 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