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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.
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
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
Name:     Henrik Skjodt, MD, PhD
Telephone: 3632 3311
Name:     Henrik Skjodt, MD, PhD
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

- 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
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)
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 available:
Date Posted:
Date Completed:
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