Thalidomide in Treating Crohn's Disease

NCT02501291 | Completed Phase 2 DMC

• 1 other identifier: IBD201501
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by relapse and progression. The incidence and prevalence of IBD are increasing in different regions around the world, indicating its emergence as a global disease. Though modern medical therapies including immunomodulators and biologic agents have revolutionized treatment of CD, the occurrence of steroids-dependence and resistance or intolerance to medical therapy is quite common. The limitation of present therapeutic management and the high expense of biologic agents leads to the treatment of CD become "refractoriness". The occurrence rate of steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the management of such refractory CD remains a great therapeutic challenge for clinicians. Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis factor)-a- suppressing effects. The potential role for thalidomide in the treatment of refractory paediatric and adult CD has been investigated in more and more small open-label studies and retrospective case series. Recently, a randomized controlled trial showed thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a median of 58 months. However, the dose of thalidomide used in these studies ranged from 50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite high. The side effects related to the dose of thalidomide were the major concerns of using it in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing which is a more objective and important outcome in CD was rarely reported. Therefore the aim of this study is to investigate the efficacy on clinical and endoscopic response and the adverse effects of using low-dose thalidomide in active adult CD patients.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Clinical remission

  Clinical remission is defined as CDAI (Crohn's disease activity index) less than 150.

  8 weeks

Secondary Outcomes (1)

• clinical response and endoscopic efficacy

  24 weeks

Study Arms (1)

Thalidomide

EXPERIMENTAL

Thalidomide was administered at a daily dose of 50 mg to the patients. Dosage adjustment of thalidomide from 25mg daily to 100mg daily was tailored individually according to patients' tolerance to thalidomide. To minimize the sedative effect of thalidomide, the investigators recommended patients take a single dose of the study drug in the evening before bedtime.

Drug: Thalidomide

Interventions

Thalidomide DRUG

Thalidomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

• Lazzerini M, Martelossi S, Magazzu G, Pellegrino S, Lucanto MC, Barabino A, Calvi A, Arrigo S, Lionetti P, Lorusso M, Mangiantini F, Fontana M, Zuin G, Palla G, Maggiore G, Bramuzzo M, Pellegrin MC, Maschio M, Villanacci V, Manenti S, Decorti G, De Iudicibus S, Paparazzo R, Montico M, Ventura A. Effect of thalidomide on clinical remission in children and adolescents with refractory Crohn disease: a randomized clinical trial. JAMA. 2013 Nov 27;310(20):2164-73. doi: 10.1001/jama.2013.280777.

  PMID: 24281461 RESULT

• Gerich ME, Yoon JL, Targan SR, Ippoliti AF, Vasiliauskas EA. Long-term outcomes of thalidomide in refractory Crohn's disease. Aliment Pharmacol Ther. 2015 Mar;41(5):429-37. doi: 10.1111/apt.13057. Epub 2014 Dec 15.

  PMID: 25511905 RESULT

MeSH Terms

Conditions

Crohn Disease

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: July 17, 2015
• Study Start: January 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

CN (1)