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Methotrexate for Crohn's Disease (COMBINE Trial)

Phase 3
Waitlist Available
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until treatment failure, assessed up to 3 years.
Awards & highlights
Pivotal Trial

Summary

This trial tests if adding a medicine to existing treatment can help kids with Crohn's Disease stay in remission without steroids.

Eligible Conditions
  • Crohn's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until treatment failure, assessed up to 3 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until treatment failure, assessed up to 3 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Participants Experiencing Treatment Failure
Secondary study objectives
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 104
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 52
Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-52 Weeks
+2 more

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987
11%
Rheumatoid arthritis
11%
Rhinitis
9%
Asthenia
9%
Bronchitis
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
8%
Arthralgia
8%
Headache
7%
Neutropenia
6%
Diarrhoea
5%
Back pain
5%
Hepatocellular injury
5%
Transaminases increased
5%
Insomnia
5%
Abdominal pain
4%
Urinary tract infection
3%
Ear infection
3%
Injection site erythema
3%
Pruritus
2%
Nausea
2%
Hypertension
1%
Gastric volvulus
1%
Angioedema
1%
Gastric ulcer
1%
Intestinal ischaemia
1%
Pulmonary embolism
1%
Deep vein thrombosis
1%
Hypertensive crisis
1%
Iron deficiency anaemia
1%
Cataract
1%
Cervical dysplasia
1%
Disseminated tuberculosis
1%
Septic shock
1%
Meningitis tuberculous
1%
Fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ COMBO - All Participants
TCZ MONO - All Participants
TCZ - All Participants

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MethotrexateExperimental Treatment1 Intervention
Methotrexate (10, 12.5, or 15 mg), once weekly. Weight-based dosing. Ondansetron (4 mg), twice weekly, 1 hour prior to methotrexate dose and the morning after methotrexate dose. Folic Acid (1 mg) daily
Group II: Sugar pill (placebo)Placebo Group1 Intervention
Placebo for methotrexate, once weekly. Placebo for ondansetron, twice weekly, 1 hour prior to methotrexate placebo dose and the morning after methotrexate placebo dose. Folic Acid (1 mg) daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate
2019
Completed Phase 4
~4400

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,819 Previous Clinical Trials
8,161,777 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,206 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
837 Previous Clinical Trials
6,565,037 Total Patients Enrolled
~34 spots leftby Nov 2025
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