TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: CRPS; Chronic Regional Pain Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Etanercept

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.4 ml/kg of normal saline will be administered subcutaneously.	Drug: Placebo; The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.; Other Names: Normal Saline
Experimental: Etanercept; Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.	Drug: Etanercept; The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.; Other Names: Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	intrapatient comparisons of Visual Analog Scale on Day 35 vs Visual Analog Scale on Day 1, comparing active drug to placebo groups.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adolescent Pediatric Pain Tool	The Adolescent Pediatric Pain Tool is a survey that will be administered at baseline and at the end of each of the four weeks of treatment.	At end of each week of treatment
Skin Temperature and Volume of Affected Limb	The skin temperature and volume of the affected limb will be measured at the beginning and end of the study.	At beginning and end of study
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale is a survey that will be administered at the beginning and end of the study.	Beginning and end of study
Sleep Disturbance Scale for Children	The Sleep Disturbance Scale for Children is a survey that will be administered at the beginning and end of the study.	Beginning and end of the study
Sleep pattern and quality	The patient will sleep with a JawboneUp device, which will measure the sleep pattern and quality.	Daily

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 29290