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Salvage Therapy With High/Low Methotrexate for Loss of Response to Infliximab Dose Escalation

NCT02269358 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-10-18

No results posted yet for this study

Summary

The goal of the present study is to evaluate if addition of methotrexate can restore remission after loss of response to infliximab after dose escalation.

another goal is to evaluate if low dose methotrexate can maintain remission achieved by regular dose methotrexate by 6 months.

Conditions

Interventions

DRUG

METHOTREXATE

Infliximab therapy after escalation. SC methotrexate at 15 mg/m2 , not to exceed 25 mg/m2 per week for 4 weeks. Patients in remission after 4 weeks reduce their dose by halve. patients not in remission will continue the full dose until 12 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2018-10-09
Completion
2018-10-09

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02269358 on ClinicalTrials.gov