Not Signed In -
Niemann-Pick Disease |
Classical Niemann-Pick Disease; DAF syndrome; lipoid histiocytosis (classical phosphatide); Neuronal Cholesterol Lipidosis; NP; NPD; Ophthalmoplegia, Supraoptic Vertical; Sphingomyelin lipidosis; Sphingomyelin/cholesterol lipidosis; Sphingomyelinase deficiency |
Clinical Trial: SONIC: Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease
SONIC: Study of Biologic and Immunomodulator Naïve Patients in Crohn’s Disease
This study is not yet open for patient recruitment.
|
Purpose
The purpose of this medical research study is to compare the efficacy of infliximab and infliximab plus azathioprine to azathioprine treatment of patients with moderate to severe Crohn’s Disease.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Crohn’s Disease | Drug: Infliximab Drug: Azathioprine | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: Multicenter, Randomized, Double-Blind, Active-Controlled Trial Comparing Remicade (infliximab) and Remicade plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naïve to both Immunomodulators and Biologic Therapy
Expected Total Enrollment: 500
Study start: March 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Be at least 18 years of age
- Have a Crohn's Disease Activity Index (CDAI) score of > 220 and < 400
- Have Crohn’s Disease for at least 6 weeks duration confirmed by radiography or endoscopy
- Are either corticosteroid-dependant OR being considered for at least their second course of oral systemic corticosteroids in the past 12 months, OR are 5-ASA failures.
Exclusion Criteria:
- Have had intra-abdominal surgery within 6-months
- Have an ostomy or stoma.
- Are pregnant, nursing, or planning pregnancy (both men and women)
- Have a serious concomitant illness that could interfere with the patient’s participation in the trial.
- Have used any investigational drug within 30 days
- Have a concomitant diagnosis or any history of congestive heart failure (CHF)
- Weight more than 140 kg (310 lbs)
Location Information
More Information
Record last reviewed: October 2004
Last Updated: October 19, 2004
Record first received: October 19, 2004
ClinicalTrials.gov Identifier: NCT00094458
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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