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

A double blind, randomized, placebo controlled trial of anti-TNF-alpha chimeric monoclonal antibody (Infliximab, Remicade) in complex regional pain syndrome type 1.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21058
Enrollment
24
Registered
2005-10-04
Start date
2005-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute CRPS type 1 with inflammatory signs

Interventions

Subjects are assigned to receive either intraveneous Infliximab (5mg/kg) or placebo 3 times in 6 weeks.

Sponsors

Erasmus MC, Department of Anesthesiology, Rotterdam, The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men and women between 18 and up until 65 years. Established diagnosis of CRPS-1 according to the Bruehl / Budapest criteria. Are considered eligible according to tuberculosis screening criteria.

Exclusion criteria

Exclusion criteria: 1. Disease related reasons; 2. Abnormal laboratory findings; 3. Adverse co-medication (such as corticosteroids, NSAIDs); 4. In general: concomitant congestiv heart failure, pregnancy, receiving other recombinat 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.

Design outcomes

Primary

MeasureTime frame
Reduction in clinical signs of regional inflammation.

Secondary

MeasureTime frame
Improvement in subjective scores of quality of life. Normalization of levels of inflammatory mediators in fluid of induced blisters.

Contacts

Public ContactF.J. Zijlstra

Erasmus Medical Center, Department of Anesthesiology, P.O. Box 2040

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)