Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Infliximab; Drug: Adalimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00216177

232-003

EudraCT no: 2005-001633-14

Switch/HUM 05-001

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)