Pediatric Crohn's DiseasePhase 3COMBINENCT02772965
Low Dose Oral Methotrexate in Pediatric Crohn's Disease Patients Initiating Anti-Tumor Necrosis Factor (Anti-TNF) Therapy
A Phase 3 study testing Methotrexate in people with Pediatric Crohn's Disease, run by University of North Carolina, Chapel Hill at 32 sites in United States.
Trial summary
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Pediatric Crohn's Disease
- What is being tested?
- Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 32 sitesUnited States
- Study dates
- Oct 2016to 7 Apr 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating anti-TNF therapy with infliximab or adalimumab (including biosimilars).
- Diagnosis of Crohn's Disease (CD) established confirmed by the treating clinician, and established by standard clinical criteria (radiography, endoscopy, histology).
- Ability to provide parental permission and child assent (where applicable), or adult consent for patients ages 18-20.
Who cannot join
- Prior use of anti-TNF or other biological therapy for CD
- Lack of stable home address that study medications can be mailed to
- Anticipated short length of follow up at study center (plans for family to move, transition to adult GI (gastrointestinal) provider, etc.). Patients expected to leave practice < 12 months from enrollment should not be enrolled.
- Concurrent pelvic or abdominal abscess. A recent history of abdominal or pelvic abscess, which is controlled, does not exclude the subject.
- Prior intra-abdominal surgery without a clinically significant relapse (i.e. patients starting on anti-TNF for post-op prophylaxis or for endoscopic recurrence only should not be included)
- Receipt of a live virus vaccine within the last 30 days
Show all 22Show fewer
- Pregnancy, planning to become pregnant, or high risk of pregnancy as determined by the local investigator
- Breastfeeding
- Refusal to stay abstinent or utilize 2 forms of birth control while on study medication (for female patients)
- BMI > 98% for gender and age
- Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years). A recent history of basal cell or squamous cell carcinoma, which is considered surgically cured, does not exclude the subject.Those with a recent history of colonic adenoma or dysplastic lesions should be excluded.
- Known high alcohol consumption (more than seven drinks per week)
- Patients with serum albumin < 2.5 g/dl
- Patients with white blood cell count (WBC) < 3.0 x109th/L
- Patients with platelet count < 100 x109th/L
- Patients with initial elevation of liver enzymes (AST or ALT) > 1.5 times above normal limit
- Patients with known active infection with Clostridium difficile (C. difficile) (untreated infection based on clinician assessment does not apply to colonization or infection controlled with current or prior treatment.)
- Patients with pre-existing hepatic disease
- Patients with pre-existing renal dysfunction (creatinine > 0.8 for children age<10, creatinine > 1.2 mg/dl for children age 10-18, and creatinine > 1.5 mg/dl for adults age 18 years and older).
- Patients with a pre-existing chronic lung disease other than well controlled asthma
- Current treatment with one of the following drugs: Probenecid (Probalan), Acitretin (Soriatane), Streptozocin (Zanosar), Azathioprine (Imuran, Azasan), 6-mercaptopurine (Purinethol, Purixan)
- Other concerns about the patient/family's ability to participate in the study
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Stanford Children's Health
Alto, California, 94304
University of Michigan | CS Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Egleston/Emory University
Atlanta, Georgia, 30329
Children's of Alabama
Birmingham, Alabama, 35233
MassGeneral Hospital for Children
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
The University of Vermont Children's Hospital
Burlington, Vermont, 05401
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Levine Children's Hospital
Charlotte, North Carolina, 28203
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
Dayton Children's Hospital
Dayton, Ohio, 45404
Pediatric Specialists of Virginia
Fairfax, Virginia, 22031
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Iowa Children's Hospital
Iowa City, Iowa, 52242
Nemours Children's Health System - Jacksonville
Jacksonville, Florida, 32207
Children's Mercy Hospital
Kansas City, Missouri, 64108
Nicklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06510
Mount Sinai Kravis Children's Hospital
New York, New York, 10029
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital and Medical Center Omaha
Omaha, Nebraska, 68114
Nemours Children's Health System - Orlando
Orlando, Florida, 32827
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104
St. Louis Children's Hospital | Washington University
St Louis, Missouri, 63110
Upstate Golisano Children's Hospital
Syracuse, New York, 13210
Nemours Children's Health System - Wilmington
Wilmington, Delaware, 19803
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.
Read the detailed description
Overall study duration: 6 years Multi-center study: up to 42 centers
Number of subjects: 425 Duration of treatment for each subject: up to 156 weeks (3 years)
The primary endpoint is percent of patients who experienced treatment failure over time.
- Conditions
- Pediatric Crohn's Disease
- Being tested
- Methotrexate, Sugar pill (placebo)
- Medical subject headings
- Pediatric Crohn's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate Sodium
- Oral methotrexate (MTX): The weekly dose will be 15 mg for children ≥ 40kg, 12.5 mg for children 30 to <40 kg, and 10 mg for children 20 to <30 kg.
- A twice per week, 4mg dose of ondansetron will be provided as pre-treatment to prevent nausea (study provider may opt-out of this component based on clinical judgement).
- A 1 mg dose of folic acid per day will be provided. This will help to reduce the risk of side effects in the MTX group.
Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits.
Sugar pill (placebo)Other
- Placebo for methotrexate: The weekly dose will mimic that of methotrexate.
- Placebo for ondansetron: The weekly dose will mimic that of ondansetron (study provider may opt-out of this component based on clinical judgement).
- A 1 mg dose of folic acid per day will be provided to maintain blinding.
Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits.
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | 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 Receives: Drug: Methotrexate |
| Sugar pill (placebo) | Placebo comparator | 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 Receives: Other: Sugar pill (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants Experiencing Treatment Failure
Treatment failure is defined as follows:
- Failure to achieve remission (short pediatric Crohn's disease activity index [SPCDAI] < 15) by the week 26 visit;
- If study initiated on steroids, failure to complete steroid taper by week 16;
- Short pediatric Crohn's disease activity index (SPCDAI) ≥ 15 attributed to active Crohn's disease, at two or more consecutive visits beyond the week 26 visit. Elevated SPCDAI (≥ 15) due to a non-Inflammatory Bowel Disease (IBD) reason does not count toward this outcome;
- Hospitalization for active Inflammatory Bowel Disease or abdominal surgery after week 25;
- Use of oral prednisone or prednisolone, enteral release budesonide, or intravenous (IV) methylprednisolone for over 10 weeks cumulatively, beyond week 16;
- Discontinuation of anti-TNF agent and/or study drug for lack of effectiveness or toxicity.
Measured: From randomization until treatment failure, assessed up to 3 years.
Secondary outcomes (5)
Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-52 Weeks
T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average pain interference and scores below 50 represent lower than average pain interference. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
The investigators will compare the mean of PROMIS Pain Interference T-scores at week 52 between the treatment groups.
Measured: Weeks 52 from randomization
Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-week 104
T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average pain interference and scores below 50 represent lower than average pain interference. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
The investigators will compare the mean of PROMIS Pain Interference T-scores at week 104 between the treatment groups
Measured: 104 weeks from randomization
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 52
T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average fatigue and scores below 50 represent lower than average fatigue. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
The investigators will compare the mean of PROMIS Fatigue T-scores at week 52 between the treatment groups
Measured: Week 52 from randomization
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 104
T-scores are a continuous variable. The mean in the general population is 50 (SD=10). Scores above 50 represent higher than average fatigue and scores below 50 represent lower than average fatigue. Minimal important differences (MIDs) for many PROMIS domains are in the range of 2 to 6.
The investigators will compare the mean of PROMIS Fatigue T-scores at week 104 between the treatment groups
Measured: 104 weeks from randomization
Percent of Patients With Positive Anti-TNF Antibody
Percent of patients with positive anti-TNF antibody will be compared between the two treatment groups using the chi-squared test.
Measured: Between 6 months and 2 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startOct 2016
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), The Leona M. and Harry B. Helmsley Charitable Trust, Children's Hospital Medical Center, Cincinnati, Grifols Diagnostics Solutions, Inc, National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Michael D Kappelman, MD, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772965
- Sponsor's protocol ID
- 16-0476
- Other IDs
- PCS-1406-18643, 1U19AR069525-01, PCD-MTX-001
- Acronym
- COMBINE
- Status last verified
- Jun 2022
- First submitted
- 27 Apr 2016
- Last updated
- 12 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kappelman MD, Wohl DA, Herfarth HH, Firestine AM, Adler J, Ammoury RF, Aronow JE, Bass DM, Bass JA, Benkov K, Tobi CB, Boccieri ME, Boyle BM, Brinkman WB, Cabera JM, Chun K, Colletti RB, Dodds CM, Dorsey JM, Ebach DR, Entrena E, Forrest CB, Galanko JA, Grunow JE, Gulati AS, Ivanova A, Jester TW, Kaplan JL, Kugathasan S, Kusek ME, Leibowitz IH, Linville TM, Lipstein EA, Margolis PA, Minar P, Molle-Rios Z, Moses J, Olano KK, Osaba L, Palomo PJ, Pappa H, Park KT, Pashankar DS, Pitch L, Robinson M, Samson CM, Sandberg KC, Schuchard JR, Seid M, Shelly KA, Steiner SJ, Strople JA, Sullivan JS, Tung J, Wali P, Zikry M, Weinberger M, Saeed SA, Bousvaros A. Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial. Gastroenterology. 2023 Jul;165(1):149-161.e7. doi: 10.1053/j.gastro.2023.03.224. Epub 2023 Mar 31.
PubMed 37004887
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Pragmatic Clinical Trial To Evaluate The Effectiveness Of Low Dose Oral Methotrexate In Patients With Pediatric Crohn's Disease Initiating Anti-TNF Therapy
- ClinicalTrials.gov ID
- NCT02772965
- Acronym / sponsor ID
- COMBINE / 16-0476
- Conditions
- Pediatric Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, ImproveCareNow (ICN), The Leona M. and Harry B. Helmsley Charitable Trust, Children's Hospital Medical Center, Cincinnati, Grifols Diagnostics Solutions, Inc, National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Oct 2016
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 12 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether adding low dose methotrexate to anti -TNF therapy is more effective than treatment with anti-TNF therapy alone in inducing and maintaining steroid-free remission for children with Crohn's Disease.
Detailed description
Overall study duration: 6 years Multi-center study: up to 42 centers
Number of subjects: 425 Duration of treatment for each subject: up to 156 weeks (3 years)
The primary endpoint is percent of patients who experienced treatment failure over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: MethotrexateMethotrexate (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 |
| Sugar pill (placebo) | Placebo comparator | Other: Sugar pill (placebo)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 |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating anti-TNF therapy with infliximab or adalimumab (including biosimilars).
- Diagnosis of Crohn's Disease (CD) established confirmed by the treating clinician, and established by standard clinical criteria (radiography, endoscopy, histology).
- Ability to provide parental permission and child assent (where applicable), or adult consent for patients ages 18-20.
Key exclusion criteria (22 listed)
- Prior use of anti-TNF or other biological therapy for CD
- Lack of stable home address that study medications can be mailed to
- Anticipated short length of follow up at study center (plans for family to move, transition to adult GI (gastrointestinal) provider, etc.). Patients expected to leave practice < 12 months from enrollment should not be enrolled.
- Concurrent pelvic or abdominal abscess. A recent history of abdominal or pelvic abscess, which is controlled, does not exclude the subject.
- Prior intra-abdominal surgery without a clinically significant relapse (i.e. patients starting on anti-TNF for post-op prophylaxis or for endoscopic recurrence only should not be included)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: Methotrexate Sodium1. Oral methotrexate (MTX): The weekly dose will be 15 mg for children ≥ 40kg, 12.5 mg for children 30 to <40 kg, and 10 mg for children 20 to <30 kg. 2. A twice per week, 4mg dose of ondansetron will be provided as pre-treatment to prevent nausea (study provider may opt-out of this component based on clinical judgement). 3. A 1 mg dose of folic acid per day will be provided. This will help to reduce the risk of side effects in the MTX group. Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits. | Drug | Methotrexate |
| Sugar pill (placebo)1. Placebo for methotrexate: The weekly dose will mimic that of methotrexate. 2. Placebo for ondansetron: The weekly dose will mimic that of ondansetron (study provider may opt-out of this component based on clinical judgement). 3. A 1 mg dose of folic acid per day will be provided to maintain blinding. Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits. | Other | Sugar pill (placebo) |
Primary outcome
Percent of Participants Experiencing Treatment Failure
Time frame: From randomization until treatment failure, assessed up to 3 years.
Treatment failure is defined as follows: 1. Failure to achieve remission (short pediatric Crohn's disease activity index [SPCDAI] < 15) by the week 26 visit; 2. If study initiated on steroids, failure to complete steroid taper by week 16; 3. Short pediatric Crohn's disease activity index (SPCDAI) ≥ 15 attributed to active Crohn's disease, at two or more consecutive visits beyond the week 26 visit. Elevated SPCDAI (≥ 15) due to a non-Inflammatory Bowel Disease (IBD) reason does not count toward this outcome; 4. Hospitalization for active Inflammatory Bowel Disease or abdominal surgery after week 25; 5. Use of oral prednisone or prednisolone, enteral release budesonide, or intravenous (IV) methylprednisolone for over 10 weeks cumulatively, beyond week 16; 6. Discontinuation of anti-TNF agent and/or study drug for lack of effectiveness or toxicity.
5 secondary outcomes
Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-52 Weeks
Time frame: Weeks 52 from randomization
Mean Patient Reported Outcome Measurement and Information System (PROMIS ) Pain Interference T-score-week 104
Time frame: 104 weeks from randomization
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 52
Time frame: Week 52 from randomization
Mean PROMIS (Patient Reported Outcome Measurement and Information System) Fatigue T Score-week 104
Time frame: 104 weeks from randomization
Percent of Patients With Positive Anti-TNF Antibody
Time frame: Between 6 months and 2 years from randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37004887Kappelman MD, Wohl DA, Herfarth HH, Firestine AM, Adler J, Ammoury RF, Aronow JE, Bass DM, Bass JA, Benkov K, Tobi CB, Boccieri ME, Boyle BM, Brinkman WB, Cabera JM, Chun K, Colletti RB, Dodds CM, Dorsey JM, Ebach DR, Entrena E, Forrest CB, Galanko JA, Grunow JE, Gulati AS, Ivanova A, Jester TW, Kaplan JL, Kugathasan S, Kusek ME, Leibowitz IH, Linville TM, Lipstein EA, Margolis PA, Minar P, Molle-Rios Z, Moses J, Olano KK, Osaba L, Palomo PJ, Pappa H, Park KT, Pashankar DS, Pitch L, Robinson M, Samson CM, Sandberg KC, Schuchard JR, Seid M, Shelly KA, Steiner SJ, Strople JA, Sullivan JS, Tung J, Wali P, Zikry M, Weinberger M, Saeed SA, Bousvaros A. Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial. Gastroenterology. 2023 Jul;165(1):149-161.e7. doi: 10.1053/j.gastro.2023.03.224. Epub 2023 Mar 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Kappelman, MD study director
University of North Carolina, Chapel Hill
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate in people with Pediatric Crohn's Disease, run by University of North Carolina, Chapel Hill at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Experiencing Treatment Failure (time frame: From randomization until treatment failure, assessed up to 3 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.