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NCT Number: NCT02501291

Thalidomide in Treating Crohn's Disease

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A CDAI score greater than 150 at baseline was required for inclusion .(1) steroid-dependent: unable to reduce steroids below the equivalent of prednisone 10 mg/day (or budesonide below 3 mg/day) within 3 months of starting steroids, or who have a relapse within 3 months of stopping steroids.(2) thiopurines-non-responsive: active disease or clinical relapse despite administration of azathioprine (1.5-2 mg per kg per day) or 6-mercaptopurine (0.75-1.5 mg per kg per day) for 4 months. (3) thiopurines- intolerant: intolerance to or adverse events of thiopurines.

The exclusion criteria were (1) isolated L4 CD; (2) disease including symptomatic stenosis of intestine or abdominal abscess requiring immediate surgery; (3) Current or past history of malignancy or organ transplantation; (4) Serious infections within 3 months; (5) Previous history of neuropathy or symptoms of neuropathy or abnormal electromyography prior to thalidomide; (6) infliximab treatment in the previous 8 weeks; (7) progressive or uncontrolled renal, hepatic, hematological, pulmonary and cardiac disease and（8）ongoing pregnancy.

Treatment and study plan

thalidomide

Drug

Primary outcomes

  1. Clinical remission

    Time frame: 8 weeks

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

Secondary outcomes

  1. clinical response and endoscopic efficacy

    Time frame: 24 weeks

    Clinical response was defined as a decrease in CDAI score of ≥100 points from baseline. Endoscopic efficacy was reassessed by ileocolonoscopy at week 24. Endoscopic outcome measures included endoscopic response (decrease in CDEIS score >5 points from baseline of CDEIS of 6 or more), complete remission (CDEIS score <3) and mucosal healing (no ulcer)response was defined as a decrease in CDAI score of ≥100 points from baseline. Endoscopic efficacy was reassessed by ileocolonoscopy at week 24. Endoscopic outcome measures included endoscopic response (decrease in CDEIS score >5 points from baseline of CDEIS of 6 or more), complete remission (CDEIS score <3) and mucosal healing (no ulcer)

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Thalidomide in Inducing and Maintaining Remission of Crohn's Disease

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2015
Registry last updated
Mar 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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