Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00216177
• Other study ID #: 232-003
• Secondary ID: EudraCT no: 2005
• Status: Recruiting
• Phase: Phase 4
• First received: September 20, 2005
• Last updated: August 17, 2009
• Start date: September 2005
• Est. completion date: June 2009

Study information

• Verified date: August 2009
• Source: Hvidovre University Hospital
• Contact: Henrik Skjodt, MD, PhD
• Phone: 3632 3311
• Email: hskj[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Infliximab
Remicade
• Adalimumab
Humira

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Gentofte Amtssygehus	Copenhagen
Denmark	Glostrup Hospital	Copenhagen
Denmark	Hvidovre Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Graasten Gigthospital	Graasten

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving combined good or moderate EULAR responses at week 24		six months	No
Secondary	ACR20/50/70 response at week 2, 6, 12, 18 and 24		six months	No