TNF-alpha Inhibition in CRPS: A Randomized Controlled Trial

NCT02031211 | Withdrawn

• 1 other identifier: 29290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CRPS; Chronic Regional Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adolescent Pediatric Pain Tool

  At end of each week of treatment

• Skin Temperature and Volume of Affected Limb

  At beginning and end of study

• Hospital Anxiety and Depression Scale

  Beginning and end of study

• Sleep Disturbance Scale for Children

  Beginning and end of the study

• Sleep pattern and quality

  Daily

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Etanercept

EXPERIMENTAL

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

Drug: Etanercept

Interventions

Etanercept DRUG

The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.

Also known as: Enbrel

Etanercept

Placebo DRUG

The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.

Also known as: Normal Saline

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Female pediatric Chronic Regional Pain Syndrome (CRPS) patients with unilateral CRPS of the lower extremity, ages 10-17 years of age.
• 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.
• Duration of symptoms less than 4 months.

You may not qualify if:

• Active malignancy or history of malignancy.
• Active infection.
• History of Tuberculosis (TB) or TB exposure.
• Pregnancy.
• Concomitant disease causing immunocompromise.
• Concomitant autoimmune disease such as rheumatoid arthritis, psoriasis, ankylosing spondylitis or Crohn's Disease.
• Poorly controlled psychiatric disease including anxiety, depression or attention deficit hyperactivity disorder.
• Hepatic or renal impairment as indicated by serum transaminases and/or creatinine ≥ 150% normal value for age.
• Evidence of or history of demyelinating disease.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Etanercept; Saline Solution

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

US (1)