TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 4/2/2016 |
| Start Date: | June 2014 |
| Contact: | Srinivas Naidu, MD |
| Email: | snaiduz@stanford.edu |
Etanercept for the Treatment of Chronic Regional Pain Syndrome
Studying the effects of Etanercept (an anti-Tumor Necrosis Factor alpha) on early Chronic
Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient
symptoms if given in early CRPS.
Regional Pain Syndrome (CRPS). Our hypothesis is that Etanercept will improve patient
symptoms if given in early CRPS.
Inclusion Criteria:
1. Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS
of the lower extremity, ages 10-17 years of age.
2. Patients must meet CRPS Type I diagnostic criteria and have current evidence of
edema, and a temperature difference between the affected and contralateral limb
≥1.0°C.
3. Duration of symptoms less than 4 months.
Exclusion Criteria:
1. Active malignancy or history of malignancy.
2. Active infection.
3. History of Tuberculosis (TB) or TB exposure.
4. Pregnancy.
5. Concomitant disease causing immunocompromise.
6. Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing
spondylitis or Crohn's Disease.
7. Poorly controlled psychiatric disease including anxiety, depression or attention
deficit hyperactivity disorder.
8. Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥
150% normal value for age.
9. Evidence of or history of demyelinating disease.
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