Clinical Trial: SONIC: Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease


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SONIC: Study of Biologic and Immunomodulator Naïve Patients in Crohn’s Disease

This study is not yet open for patient recruitment.

Sponsored by:	Centocor
Information provided by:	Centocor

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

Further Study Details:

Primary Outcomes: Steroid-free remission

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

Bob Diamond, MD 215-325-8252 Bdiamond@cntus.jnj.com

More Information

Study ID Numbers: C0168T67
Record last reviewed: October 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 2004-11-10

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