Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Phase 4

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00216177
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2009-01
• Study Completion: 2009-06
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-17
• Last Update Posted: 2009-08-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving combined good or moderate EULAR responses at week 24	six months

Secondary Outcome Measures

Name	Time	Method
ACR20/50/70 response at week 2, 6, 12, 18 and 24	six months

Trial Locations

Locations (6)

Hvidovre Hospital; 🇩🇰 Copenhagen, Denmark

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte Amtssygehus; 🇩🇰 Copenhagen, Denmark

Glostrup Hospital; 🇩🇰 Copenhagen, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Graasten Gigthospital; 🇩🇰 Graasten, Denmark