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

NCT02269358 | Completed Phase 4 DMC

• 1 other identifier: 0143-14-WOMC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• remission

  remission without additional therapy.

  at 12 weeks

Secondary Outcomes (3)

• Remission

  6 months

• Trough levels

  week 12

• ATIs

  week 12

Study Arms (1)

Addition of methotrexate

EXPERIMENTAL

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

Drug: METHOTREXATE

Interventions

METHOTREXATE DRUG

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.

Also known as: Rheumatrex, Trexall

Addition of methotrexate

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent
• Established diagnosis of Crohns disease.
• Age: 8 - 18 years ( inclusive)
• Active disease PCDAI \>10 at least two weeks after infusion.
• On Infliximab with at least 3 prior infusions, and still active despite a decreased dose interval ( ≤ 6 weeks) or increased dose of infliximab (≥7.5 mg/kg /dose q 8 weeks).
• Comment: Patients who are on combination therapy with a stable thiopurine\>8 weeks can also be included ( thiopurine will be stopped at enrollment).

You may not qualify if:

• \. Patients who are primary non responders after first two doses 2. Patients who have had to stop infliximab due to side effects. 3. Patients with known intolerance to methotrexate. 4. Elevated ALT \>1.5 normal. 5. Pregnancy. 6. Patients who have insulin-dependent diabetes 7. Patients who have significantly impaired renal function 8. Current bacterial infection/ inflammation including Hepatitis B or C and Pneumonia.

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (1)

The E. Wolfson.Medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Arie Levine, MD

  Pediatric Gastroenterology and Nutrition Unit, The E. Wolfson MC, Tel-Aviv University, Holon, Israel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and Nutrition unit.

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 21, 2014
• Study Start: July 1, 2015
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

IL (1)