Anti-TNF Therapy for Crohn's Disease in Children

(CAMEO Trial)

Recruiting at 26 trial locations

Overseen By Dena E Hopkins, MPH, CCRP

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Connecticut Children's Medical Center

Must be taking: Anti-TNF therapy

Must not be taking: Non-anti TNF biologics

Disqualifiers: Pregnancy, Diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 52 weeks

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some children with Crohn's disease heal better than others after starting anti-TNF therapy, which reduces inflammation in the intestines. By studying markers of inflammation in the blood and stool and examining genetic factors, researchers aim to improve personalized treatment plans. The trial seeks children aged 6 to 17 who are newly diagnosed with Crohn's and beginning treatment with anti-TNF medicines like adalimumab (Humira) or infliximab (Remicade, Avsola, Inflectra, Renflexis, Ixifi, Zymfentra) within six months of diagnosis. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, if you have used certain medications like oral corticosteroids for non-gastrointestinal issues or investigational drugs recently, you may not be eligible. It's best to discuss your current medications with the trial team.

What is the safety track record for Adalimumab and Infliximab?

Research has shown that both adalimumab and infliximab are generally safe for treating children with Crohn's disease. Studies have found that adalimumab helps maintain symptom-free status in children. While some side effects occur, they are usually mild.

Infliximab is also effective for children with Crohn's disease, though it carries a higher risk of serious infections compared to non-biological therapies.

The FDA has approved both adalimumab and infliximab for treating Crohn's disease in children, providing added safety assurance. Parents should be aware of possible side effects and discuss them with healthcare providers to ensure the best care for their children. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about treatments like Adalimumab and Infliximab for Crohn's disease because they work by targeting tumor necrosis factor (TNF), a protein that plays a crucial role in inflammation. Unlike traditional therapies that may take longer to address symptoms, these anti-TNF drugs have the potential to more quickly reduce inflammation and start healing the gut. This targeted approach could mean better outcomes and improved quality of life for young patients newly diagnosed with Crohn's.

What is the effectiveness track record for anti-TNF therapy in treating Crohn's disease?

Research shows that both adalimumab and infliximab, which block a protein called TNF, effectively treat children with Crohn's disease. In this trial, participants will receive anti-TNF therapy, which may include either adalimumab or infliximab. Studies have found that adalimumab helps control symptoms in many children with moderate to severe Crohn's disease and can reduce the need for corticosteroids, strong anti-inflammatory drugs. Infliximab has also proven effective, with doses of 5 and 10 mg/kg achieving better symptom control than lower doses. Additionally, infliximab has shown positive results in healing the intestines, as observed through a special camera. These findings support using these treatments to manage Crohn's disease in young patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Jeffrey S Hyams, MD

Principal Investigator

Connecticut Children's Medical Center

Subra Kugathasan, MD

Principal Investigator

Emory University

Lee Denson, MD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

Inclusion Criteria

Phase 1 Inclusion Criteria (all must be fulfilled)

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive anti-TNF therapy for Crohn's disease, with monitoring of inflammation markers and therapeutic drug levels

52 weeks

Regular visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of healing through colonoscopy and MRI

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Adalimumab
• Infliximab

How Is the Trial Designed?

Group I: Anti-tumor necrosis factor (TNF) Experimental Treatment 1 Intervention

Patients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis

Adalimumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in United States as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis
• Hidradenitis suppurativa

Approved in Canada as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Approved in Japan as Humira for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10873464/

Efficacy and safety of adalimumab in pediatric patients with ... The primary outcomes were induction (≤ 12 weeks) and maintenance (up to 48 weeks) of remission and response. Secondary outcomes were severe ...

2. humirapro.com humirapro.com/pediatric-crohns-disease

HUMIRA® (adalimumab) for Pediatric Crohn's Disease Learn about HUMIRA efficacy and safety data in maintaining clinical remission and response in children with moderate to severe Crohn's disease (CD).

3. naspghan.org naspghan.org/files/documents/pdfs/training/curriculum-resources/ibd/IMAgINE_1.pdf

Safety and Efficacy of Adalimumab for Moderate to Severe ... More children who received high compared with low dose were in remission at week 26, but the difference between dose groups was not statistically significant.

4. academic.oup.com academic.oup.com/ecco-jcc/article/18/Supplement_1/i1081/7586827

P553 The safety and efficacy of adalimumab 80mg weekly as ... Our findings support the safety and efficacy of administering ADL at a weekly dosage of 80 mg as maintenance therapy in pediatric patients with moderate to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02256462

Pediatric Crohn's Disease AdalImumab Level-based ... Main outcome measures: Pediatric Crohn's Activity Index (PCDAI) at 48 and 72 weeks. Secondary outcome measures: Corticosteroids free remission rates and on ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/125057s410lbl.pdf

HUMIRA® (adalimumab) injection, for subcutaneous use In the Phase 3 trial of. HUMIRA in pediatric patients with Crohn's disease which evaluated efficacy and safety of two body weight based maintenance dose ...

7. humira.com humira.com/pediatric-crohns/

HUMIRA® (adalimumab) for Pediatric Crohn's Disease Discover HUMIRA® (adalimumab), a treatment for moderate to severe pediatric Crohn's disease (CD). See Full Prescribing & Safety Info, and BOXED WARNING.