TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

Stanford University

Status: Withdrawn

Conditions: CRPS; Chronic Regional Pain Syndrome

Treatments: Drug: Placebo; Drug: Etanercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02031211

29290

Details and patient eligibility

About

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.

Sex: Female

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0.4 ml/kg of normal saline will be administered subcutaneously.

Treatment:

Drug: Placebo

Etanercept

Experimental group

Description:

Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.

Treatment:

Drug: Etanercept