Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease (CAMEO)
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ClinicalTrials.gov Identifier: NCT05781152 |
Recruitment Status :
Recruiting
First Posted : March 23, 2023
Last Update Posted : April 16, 2024
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Condition or disease | Intervention/treatment | Phase |
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Crohn Disease | Drug: Anti-TNF therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 900 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease |
Actual Study Start Date : | June 10, 2023 |
Estimated Primary Completion Date : | July 1, 2028 |
Estimated Study Completion Date : | July 1, 2029 |
Arm | Intervention/treatment |
---|---|
Anti-tumor necrosis factor (TNF)
Patients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis
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Drug: Anti-TNF therapy
Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool
Other Name: Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio |
- Complete healing (CH) [ Time Frame: 52 weeks from anti-TNF start ]
The achievement of complete healing (CH) 52 weeks after initiation of anti-TNF therapy guided by ROADMAB™ (therapeutic drug monitoring) as evidenced by a composite of all of the following four features below:
- Endoscopic healing (EH) determined by centrally read ileocolonoscopy (total SES-CD score <3)
- Transmural healing (TH) determined by centrally read MRE (no segmental MaRIAs score of ≥1)
- Corticosteroid free for a minimum of 4 weeks
- The absence of either intestinal resection or the addition of a nutritional, biological or small molecule therapeutic agent other than anti-TNF± concomitant IM
- Endoscopic mucosal healing only [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic mucosal healing only (total Simple Endoscopic Score - Crohn's Disease (SES-CD) <3)
- Transmural healing only [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural healing only (no segmental simplified magnetic resonance index of activity (MaRIAs) score ≥1)
- Clinical remission [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Clinical remission (weighted Pediatric Crohn's Disease Activity Index (wPCDAI) < 12.5)
- Fecal calprotectin [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Fecal calprotectin <250 ug/g
- Endoscopic response [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic response: 50% reduction in SES-CD
- Transmural response [ Time Frame: 52 weeks ]Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural response: 50% reduction in MaRIAs
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Ages Eligible for Study: | 6 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Phase 1 Inclusion Criteria
- Age ≥ 6 years and < 18 years at enrollment
- Suspected diagnosis of CD
- Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin.
- Parent/guardian consent and patient assent
- Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy
Phase 1 Exclusion Criteria
- Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation
- Investigator judgment that patient has high likelihood (>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture)
- Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)
- Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling
- Pregnancy
- Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
- Previous treatment with immunomodulators or anti-TNF therapy for other medical conditions (e.g., juvenile idiopathic arthritis) at any time prior to enrollment
- Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitis
- Inability to have MRE because of claustrophobia or other reasons
Phase 2 Inclusion Criteria
- Met all eligibility criteria for Phase 1 and participated in Phase 1
- Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation
- MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details.
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Received at least one of the following as initial therapy upon diagnosis:
- Corticosteroids
- Immunomodulator
- Defined nutritional therapy
- Anti-TNF (adalimumab or infliximab)
- Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulator
6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing 7. Parent/guardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapy
Phase 2 Exclusion Criteria
- Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE
- Orofacial CD only
- Esophageal, gastric, duodenal, and/or jejunal CD only
- Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary.
- Perianal CD only with no evidence of luminal disease
- Internal fistulizing disease at diagnosis
- Initial IBD treatment with non-anti-TNF biologic or small molecule therapy
- Received any anti-TNF agent other than adalimumab or infliximab
- Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up
- Inability to have MRE because of claustrophobia or other reasons
- Video of baseline endoscopy not available for central reading
- Underwent bowel resection within 3 months of diagnosis (TD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05781152
Contact: Dena E Hopkins, MPH, CCRP | 860-545-8125 | CAMEO_CCC@connecticutchildrens.org | |
Contact: Jeffrey S Hyams, MD | 860-545-9560 | jhyams@connecticutchildrens.org |
Principal Investigator: | Jeffrey S Hyams, MD | Connecticut Children's Medical Center | |
Principal Investigator: | Subra Kugathasan, MD | Emory University | |
Principal Investigator: | Lee Denson, MD | Children's Hospital Medical Center, Cincinnati |
Documents provided by Connecticut Children's Medical Center:
Responsible Party: | Connecticut Children's Medical Center |
ClinicalTrials.gov Identifier: | NCT05781152 |
Other Study ID Numbers: |
22-066 1U01DK134356-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 23, 2023 Key Record Dates |
Last Update Posted: | April 16, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The final dataset will include de-identified demographic, clinical, genetic, serological, immune, microbiome, and gene expression data along with patient outcomes. The project will generate a bank of biological samples including serum, plasma, genomic DNA, ileal and colonic biopsy DNA & RNA, and stool. The investigators will use a data sharing agreement that provides for a commitment to using the data only for research purposes, a commitment to securing the data using appropriate computer technology, and a commitment to destroying or returning the data after analyses are completed. The data and access to the biospecimens for ancillary studies will be made available in a timely fashion following completion and publication of the primary outcome papers. The investigators will follow the prevailing standards and NIDDK Data Sharing Policy guidelines in documenting and depositing data sets. Quality-controlled raw data and processed data used in publications will be made available. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | 3 years after final outcome data collection |
Access Criteria: | The institutions and PIs will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
crohn disease children pediatric anti-TNF therapy therapeutic drug monitoring |
intestinal microbiome inflammatory bowel disease gene expression genomic DNA |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Infliximab Tumor Necrosis Factor Inhibitors Anti-Inflammatory Agents Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |