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

ISRCTN ISRCTN75765780
DOI https://doi.org/10.1186/ISRCTN75765780
Secondary identifying numbers N/A
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
18/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
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

Contact information

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

Study information

Study designRandomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymInCRePaS study
Study objectivesInfliximab 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) studiedComplex regional pain syndrome type 1 (CRPS I)
InterventionSubjects are assigned to receive either intraveneous Infliximab (5 mg/kg) or placebo 3 times in 6 weeks
Intervention typeOther
Primary outcome measureReduction in clinical signs of regional inflammation
Secondary outcome measures1. Improvement in subjective scores of quality of life
2. Normalisation of levels of inflammatory mediators in fluid of induced blisters
Overall study start date01/11/2005
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants24
Key inclusion criteria1. 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 criteria1. 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 enrolment01/11/2005
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3000 CA
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

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

ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Industry

Centocor B.V. (Netherlands)

No information available

Ministry of Economic Affairs (Netherlands)
Government organisation / National government
Alternative name(s)
Ministry of Economic Affairs, Netherlands Ministry of Economic Affairs, EZ
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan