Reduce Risk for Crohn's Disease Patients

NCT02852694 | Completed Phase 4 DMC

• 1 other identifier: 2016-01
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of weekly subcutaneously administered Methotrexate for maintaining relapse-free sustained steroid/Enteral Nutrition -free 1-year remission compared with:

• daily oral Azathioprine / 6 mercaptopurine in low risk paediatric Crohn's disease
• subcutaneously administered adalimumab in high risk paediatric Crohn's disease

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Rate of sustained steroid/EEN-free remission at Month 12

  Rate of sustained steroid/EEN-free remission at Month 12, where sustained remission is defined as wPCDAI (weighted pediatric crohn disease activity index) ≤12.5 and CRP ≤1,5 fold the normal upper limit without a relapse since week 12.

  Month 12

Secondary Outcomes (15)

• Time to first relapse

  Month 12

• Remission at 12 weeks (measured by wPCDAI</=12.5 and normal CRP and being off steroids/exclusive enteral nutrition)

  12 weeks

• Linear height velocity

  12 months

• Steroid sparing effect of the regimens

  12 months

• Comparison of toxicity of the different protocol drugs

  12 months

Study Arms (3)

High Risk Group

ACTIVE COMPARATOR

subcutaneous methotrexate versus subcutaneous adalimumab

Drug: Methotrexate; Drug: Adalimumab

Low risk group

ACTIVE COMPARATOR

subcutaneous methotrexate versus oral dose of azathioprine / 6 mercaptopurine

Drug: Methotrexate; Drug: Azathioprine / 6 Mercaptopurine

Ancillary

OTHER

the ancillary study is planned to analyse of Adalimumab treated patients from inclusion (TOP-Down) versus patients switched to Adalimumab due to failure of immunomodulator therapy (STEP-Up).

Drug: Adalimumab

Interventions

Methotrexate DRUG

Subcutaneous methotrexate once weekly 15mg/m2 body surface area (19, 30), with a maximal dose of 25mg/week. Odansetron (Zofran) premedication (4-8mg 1Hour prior to injection) is recommended, folate acid substitution (15mg po, 3 days after Methotrexate injection, for children \<20kg: 1x 5mg) is recommended.

High Risk Group; Low risk group

Adalimumab DRUG

Subcutaneous Adalimumab started at a dose of 160mg followed by 80mg 2 weeks later and then 40mg every 2 weeks in patients over 40kg. In patients \< 40kg sc doses of Adalimumab are as follows: induction 160mg/1,73m2 BSA (max 160mg), followed by 80mg/1,73m2 Body surface area (max 80mg) 2 weeks later and maintenance of 40mg/1,73m2 Body surface area (max 40mg) every 2 weeks, all doses rounded up to the nearest 5 multiplications.

Also known as: humira

Ancillary; High Risk Group

Azathioprine / 6 Mercaptopurine DRUG

Oral Azathioprine /6mercaptopurine at a dose of 2.5 mg/kg once daily rounded to the nearest multiplication of 12.5mg or oral 6mercaptopurine at a dose of 1.5mg/kg once daily rounded to the nearest multiplication of 12.5mg.

Also known as: imurel / purinethol

Low risk group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-17, with a new-onset Crohn Disease diagnosed using established criteria (37, 38), requiring a steroid-based or Enteral nutrition based induction therapy
• At initial diagnosis, wPCDAI \>40 or CRP\>2 times upper limit at diagnosis
• Luminal active Crohn Disease (B1) with or without B2 and/or B3 disease behavior
• Initial exposure to 5-ASA and derivate is tolerated
• Exposure to antibiotics is tolerated
• If one of the following criteria is present, patients are allocated to the high risk group prior randomization:
• Complex fistulizing perianal disease
• Panenteric disease phenotype (defined as L3 with L4b per Paris classification or L3 with deep ulcers in duodenum, stomach or oesophagus (not HP (helicobacter pylori)- or NSAID-related))
• Severe growth impairment (height z-score \<-2 or crossing 2 percentiles or more) likely related to CD
• Significant hypoalbuminemia (\<30g/l), elevated C reactive protein (CRP) (at least 2 times above normal range), or wPCDAI \>12.5 despite 3 weeks of optimized induction therapy with steroids or Exclusive enteral nutrition
• B2, B3 or B2B3 disease behavior
• Overall cumulative disease extend of ≥60 cm
• Informed and signed consent

You may not qualify if:

• Patients with wPCDAI\<42,5 at initial diagnosis, except if CRP\>2 times upper limit
• No induction therapy with steroids or enteral nutrition
• Previous therapy with any IBD (inflammatory bowel desease) -related medications other than induction therapy as detailed in this protocol (except 5-ASA).
• Pregnancy or refusal to use contraceptives during the study period in pubertal patients (both boys and girls) unless absolute abstinence (no sexual activity) is confirmed at each study visit. Positive pregnancy testing throughout the study will trigger prompt withdrawal of the patient from the study.
• Lactating mothers
• Children with perianal fistulising disease who require surgical therapy (drainage, seton placement)
• Patients homozygous for Thiopurine methyl transferase or those with Thiopurine methyl transferase activity \<6 nmol/h/ml erythrocytes or \<9nmol 6MTG (6 methylthioguanine/g Hb/h), unless they qualify as high risk patients
• Evidence of un-drained and un-controlled abscess/phlegmon
• Contraindication to any drugs used in the trial (including intolerance/hypersensitivity or allergy to either study drug (thiopurines, methotrexate or adalimumab))
• Current or previous malignancy
• Serious comorbidities (such as renal insufficiency, hepatitis, respiratory insufficiency) interfering with drug therapy or interpretation of outcome parameters or will make it unlikely that the patients will finish the trial.
• Infection with mycobacterium tuberculosis
• Moderate to severe heart failure (NYHA classe III/IV)
• Oral anticoagulant therapy, anti-malaria therapy

Sponsors & Collaborators

• PIBD-Net: lead
• European Commission: collaborator

Study Sites (1)

Hôpital Necker -Enfants Malades (Service de gastro-enterologie)

Paris, 75015, France

Location

Related Publications (41)

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  PMID: 32611737 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Methotrexate; Adalimumab; Azathioprine; Mercaptopurine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds

Study Officials

• Frank RUEMMELE, PhD / MD

  PIBD-Net

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: August 2, 2016
• Study Start: February 28, 2017
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)