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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03221166
Date of registration: 05/07/2017
Prospective Registration: Yes
Primary sponsor: IRCCS Burlo Garofolo
Public title: Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors
Scientific title: Thalidomide, a Novel Immunological Treatment to Modify the Natural History of Paediatric Crohn's Disease: a New Proposal From a Well-established Paediatric Research Network
Date of first enrolment: February 27, 2018
Target sample size: 9
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT03221166
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Italy
Contacts
Name:     Alessandro Ventura, MD PhD
Address: 
Telephone:
Email:
Affiliation:  IRCCS Burlo Garofolo
Key inclusion & exclusion criteria

Inclusion Criteria:

- Age at diagnosis <18 years and >=6 years

- New diagnosis of CD based on Porto criteria

- CD with inflammatory phenotype (non-penetrating, non-fistulizing) and with no need for
surgery except for perinal fistulas

- Presence of at least one of the following risk factors for poor prognosis:

- fistulizing perianal disease

- pan-enteric disease

- disease extension > 60 cm

- severe growth delay (height z-score < -2 DS)

- severe osteoporosis (z score < -2 DS)

- hypoalbuminemia (< 3g/dL) or high C-reactive protein (2 times higher the normal
range)

- Acceptance of the Risk Evaluation and Mitigation Strategy (REMS) program for reducing
the teratogenic risk.

Exclusion Criteria:

- ongoing pregnancy

- presence of peripheral neuropathy

- HIV

- patients with transplanted organs

- ongoing major infections or other severe diseases

- participation to other experimental studies.



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Infliximab
Drug: Thalidomide
Primary Outcome(s)
Efficacy in inducing mucosal healing [Time Frame: 52 weeks]
Secondary Outcome(s)
Direct and indirect costs [Time Frame: 52 weeks]
Efficacy in inducing clinical remission [Time Frame: 12 weeks]
Efficacy in inducing clinical remission [Time Frame: 52 weeks]
Efficacy in inducing clinical response [Time Frame: 12 weeks]
Efficacy in inducing clinical response [Time Frame: 52 weeks]
Efficacy in modifying body mass index [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in modifying height-for-age z score [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in modifying weight-for-age z score [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in reducing C-reactive protein [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in reducing erythrocyte sedimentation rate [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in reducing faecal calprotectin [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]
Efficacy in reducing hospitalizations [Time Frame: 52 weeks]
Efficacy in reducing the need for surgery [Time Frame: 52 weeks]
Efficacy in reducing the need to change therapy [Time Frame: 12 weeks]
Efficacy in reducing the need to change therapy [Time Frame: 52 weeks]
Evaluation of the Treatment-Emergent Adverse Events [Time Frame: Between enrolment and 52 weeks]
Secondary ID(s)
NET-2013-02355002
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Centro di Riferimento Oncologico - Aviano
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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