Comparison of 2 Immunomodulator Withdrawal Schemes for Infliximab Monotherapy in Active Pediatric Crohn's Disease After Thiopurine Failure

Summary

The goal of the present study is to evaluate the best regimen for infliximab monotherapy, and to evaluate if limited combination therapy with IFX and an Immunomodulator for the first 6 months of therapy, in prior Immunomodulator failures, is superior to monotherapy with Immunomodulator cessation from the second infusion, in preventing loss of remission to IFX.

Conditions

• Crohn's Disease

Interventions

DRUG

AZATHIOPRINE or METHOTREXATE

Patients should continue azathioprine or 6 MP or methotrexate at their previous doses for 6 months IMM therapy 26 weeks

DRUG

AZATHIOPRINE or METHOTREXATE

Patients should continue the same dose of azathioprine or 6 MP or methotrexate until the day of the second infusion (week 2) Thiopurine therapy 2 weeks

Sponsors & Collaborators

• Prof. Arie Levine

  lead OTHER_GOV

Principal Investigators

• Arie Levine, MD · Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

• Dan Turner, MD, PhD · Pediatric Gastroenterology and Nutrition Unit, The Hebrew University of Jerusalem, Shaare Zedek MC, Jerusalem, Israel

• Raanan Shamir, MD · Schneider Childrens Hospital

• Michal Kori, MD · Kaplan Medical Center

• Michael Wilshanski, MD · Hadassah Medical Organization

• Ron Shaoul, MD · Meyer Childrens Hospital Rambam, Haifa, Israel

• Shlomi Cohen, MD · Tel Aviv Medical Center

• Batia Weiss, MD · Sheba Medical Center

• Sarit Peleg, MD · Afula Hospital

• Baruch Yerushalmi, MD · Soroka University Medical Center

• Efrat Broide, MD · Asaf Harofe Medical Center

• Avi On, MD · Poriah Hospital

• Hussein Chemali, MD · Nazheret Hospital

• Aharon Lerner, MD · Carmel Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Israel

Study Locations