Contact information
Type
Scientific
Primary contact
Dr F.J. Zijlstra
ORCID ID
Contact details
Erasmus Medical Center
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4635606
f.zijlstra@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
InCRePaS study
Study hypothesis
Infliximab counteracts the increased synthesis of tumor necrosis factor alpha (TNF-alpha), after which inflammation will decrease and recovery of the disease occur.
Ethics approval
Received from local medical ethics comittee
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Complex regional pain syndrome type 1 (CRPS I)
Intervention
Subjects are assigned to receive either intraveneous Infliximab (5 mg/kg) or placebo 3 times in 6 weeks
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Reduction in clinical signs of regional inflammation
Secondary outcome measures
1. Improvement in subjective scores of quality of life
2. Normalisation of levels of inflammatory mediators in fluid of induced blisters
Overall trial start date
01/11/2005
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women between 18 and up until 65 years
2. Established diagnosis of CRPS-1 according to the Bruehl/Budapest criteria
3. Are considered eligible according to tuberculosis screening criteria
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
24
Participant exclusion criteria
1. Disease related reasons
2. Abnormal laboratory findings
3. Adverse co-medication (such as corticosteroids, non-steroidal anti-inflammatory drugs [NSAIDs])
4. In general: concomitant congestive heart failure, pregnancy, receiving other recombinant products, history of serious infections, HIV, hepatitis B or C, abnormal chest radiograph, history of lymphoproliferative disease, opportunistic infection (e.g. herpes zoster), presence of a transplanted solid organ, history of alcohol abuse
Recruitment start date
01/11/2005
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Industry
Funder name
Centocor B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Economic Affairs (Netherlands)
Alternative name(s)
Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list