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Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until treatment failure, assessed up to 3 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until treatment failure, assessed up to 3 years.
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 moreSide effects data
From 2015 Phase 3 trial • 139 Patients • NCT0200198711%
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
2,843 Previous Clinical Trials
8,172,927 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
502 Previous Clinical Trials
1,089,712 Total Patients Enrolled
Children's Hospital Medical Center, CincinnatiOTHER
839 Previous Clinical Trials
6,565,297 Total Patients Enrolled
Grifols Diagnostics Solutions, IncUNKNOWN
University of North Carolina, Chapel HillLead Sponsor
1,569 Previous Clinical Trials
4,319,401 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
580 Previous Clinical Trials
27,104,953 Total Patients Enrolled
ImproveCareNow (ICN)UNKNOWN
2 Previous Clinical Trials
786 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
66 Previous Clinical Trials
99,389 Total Patients Enrolled
Michael D Kappelman, MDStudy DirectorUniversity of North Carolina, Chapel Hill