Anti-TNF-alpha (Infliximab) in Complex Regional Pain Syndrome

ISRCTN	ISRCTN75765780
DOI	https://doi.org/10.1186/ISRCTN75765780
Protocol serial number	N/A
Sponsor	Erasmus Medical Centre (Netherlands)
Funders	Centocor B.V. (Netherlands), Ministry of Economic Affairs (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr F.J. Zijlstra
Scientific

Erasmus Medical Center
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Phone	+31 (0)10 4635606
Email	f.zijlstra@erasmusmc.nl

Primary study design	Interventional
Study design	Randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	InCRePaS study
Study objectives	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(s)	Received from local medical ethics comittee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Reduction in clinical signs of regional inflammation
Key secondary outcome measure(s)	1. Improvement in subjective scores of quality of life 2. Normalisation of levels of inflammatory mediators in fluid of induced blisters
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	24
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	31/12/2007

Erasmus Medical Center

Rotterdam
3000 CA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan