Etanercept for the Treatment of CRPS

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02031211
First received: January 7, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

Studying the effects of Etanercept (an anti-TNF alpha) on early CRPS. Our hypothesis is that Etanercept will improve patient symptoms if given in early CRPS.


Condition Intervention
CRPS
Chronic Regional Pain Syndrome
Drug: Etanercept

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Etanercept for the Treatment of CRPS

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Visual Analog Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The participant will keep a daily record of their pain via the Visual Analog Score.


Estimated Enrollment: 12
Study Start Date: February 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Experimental: Etanercept
Patient will receive 0.4 mg/kg of Etanercept subcutaneously twice weekly.
Drug: Etanercept

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female pediatric 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 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 ADHD.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02031211     History of Changes
Other Study ID Numbers: 29290
Study First Received: January 7, 2014
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014