Anti-TNF-alpha (Infliximab) in Complex Regional Pain Syndrome
ISRCTN | ISRCTN75765780 |
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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
Scientific
Erasmus Medical Center
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
Phone | +31 (0)10 4635606 |
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f.zijlstra@erasmusmc.nl |
Study information
Study design | Randomised double blind placebo controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 01/11/2005 |
Completion date | 31/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Female |
Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Anesthesiology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
https://ror.org/018906e22 |
Funders
Funder type
Industry
Centocor B.V. (Netherlands)
No information available
Ministry of Economic Affairs (Netherlands)
Government organisation / National government
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |