World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00216177
Date of registration: 20/09/2005
Prospective Registration: Yes
Primary sponsor: Hvidovre University Hospital
Public title: Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis
Scientific 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
Date of first enrolment: September 2005
Target sample size: 112
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00216177
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
Denmark
Contacts
Name:     Henrik Skjodt, MD, PhD
Address: 
Telephone: 3632 3311
Email: hskj@dadlnet.dk
Affiliation: 
Name:     Henrik Skjodt, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Hvidovre University Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Adalimumab
Drug: Infliximab
Primary Outcome(s)
Proportion of patients achieving combined good or moderate EULAR responses at week 24 [Time Frame: six months]
Secondary Outcome(s)
ACR20/50/70 response at week 2, 6, 12, 18 and 24 [Time Frame: six months]
Secondary ID(s)
232-003
EudraCT no: 2005-001633-14
Switch/HUM 05-001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Hospital, Gentofte, Copenhagen
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history