TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Etanercept

Criteria

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.