Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes