Thalidomide Versus Infliximab in New Onset Crohn's Disease With Poor Prognostic Factors

• 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
• 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: Thalidomide

Drug: Infliximab

Primary Outcome(s)

Efficacy in inducing mucosal healing [Time Frame: 52 weeks]

Secondary Outcome(s)

Evaluation of the Treatment-Emergent Adverse Events [Time Frame: Between enrolment and 52 weeks]

Efficacy in reducing the need for surgery [Time Frame: 52 weeks]

Efficacy in inducing clinical remission [Time Frame: 52 weeks]

Efficacy in reducing the need to change therapy [Time Frame: 52 weeks]

Efficacy in inducing clinical response [Time Frame: 12 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 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 inducing clinical remission [Time Frame: 12 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)]

Direct and indirect costs [Time Frame: 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 the need to change therapy [Time Frame: 12 weeks]

Efficacy in reducing hospitalizations [Time Frame: 52 weeks]

Efficacy in inducing clinical response [Time Frame: 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 reducing erythrocyte sedimentation rate [Time Frame: Each time point between enrolment and 52 weeks (0, 4, 8, 14, 26, 38, 52 weeks)]

Secondary ID(s)

NET-2013-02355002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centro di Riferimento Oncologico - Aviano

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia