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Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hvidovre University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00216177
First received: September 20, 2005
Last updated: August 17, 2009
Last verified: August 2009
History of Changes

September 20, 2005
August 17, 2009
September 2005
January 2009   (final data collection date for primary outcome measure)
Proportion of patients achieving combined good or moderate EULAR responses at week 24 [ Time Frame: six months ] [ Designated as safety issue: No ]
Proportion of patients achieving combined good or moderate EULAR responses at week 24
Complete list of historical versions of study NCT00216177 on ClinicalTrials.gov Archive Site
ACR20/50/70 response at week 2, 6, 12, 18 and 24 [ Time Frame: six months ] [ Designated as safety issue: No ]
ACR20/50/70 response at week 2, 6, 12, 18 and 24
Not Provided
Not Provided
 
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
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

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Infliximab
    Remicade
    Other Name: remicade
  • Drug: Adalimumab
    Humira
    Other Name: Humira
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
112
June 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Henrik Skjodt, MD, PhD 3632 3311 hskj@dadlnet.dk
Contact: Mikkel Ostergaard, MD, DMedSci mo@dadlnet.dk
Denmark
 
NCT00216177
232-003, EudraCT no: 2005-001633-14, Switch/HUM 05-001
Yes
Henrik Skjodt, Hvidovre Hospital
Hvidovre University Hospital
University Hospital, Gentofte, Copenhagen
Principal Investigator: Henrik Skjodt, MD, PhD Hvidovre Hospital
Hvidovre University Hospital
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP