The Belgian SMART Study Evaluating the Use of Golimumab for Ulcerative Colitis

Summary

Ulcerative colitis (UC) is a chronic inflammatory condition causing continuous mucosal inflammation of the colon, which is accompanied by episodes of bloody diarrhoea and abdominal pain. Both infliximab and adalimumab have been used with success for moderate-to-severe UC refractory to conventional therapy. More recently, golimumab, another anti-TNF antibody, has been added to the treatment armamentarium.

In the multi-centre, double-blind, placebo-controlled PURSUIT trial, patients with moderate-to-severe UC randomized to induction therapy with golimumab (200-100 mg, or 100-50 mg at week 0 and 2) achieved clinical response, clinical remission and mucosal healing more frequent than patients randomized to placebo. In the PURSUIT maintenance trial, patients randomized to golimumab every four weeks (100 or 50 mg) maintained clinical response through week 54 significantly more often than patients randomized to placebo. Data on the use of golimumab in daily clinical practice are unavailable.

The aim of the retrospective Belgian multi-centre BE-SMART trial is to evaluate the mid-term outcome of golimumab in patients with moderate-to-severe colitis. The primary endpoint will be steroid-free golimumab continuation at week 26. Secondary endpoints will include (steroid-free) clinical remission, (steroid-free) clinical response, (steroid-free) mucosal healing, (steroid-free) complete mucosal healing hospitalization-free survival, and colectomy-free survival.

Conditions

• Ulcerative Colitis

Sponsors & Collaborators

• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW

  collaborator OTHER

• Imelda Hospital, Bonheiden

  collaborator OTHER

• AZ Delta

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• Onze Lieve Vrouw Hospital

  collaborator OTHER

• General Hospital Groeninge

  collaborator OTHER

• University of Liege

  collaborator OTHER

• Clinique Saint Joseph, Liège

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• Chwapi Tournai

  collaborator UNKNOWN

• AZ Jan Palfijn Gent

  collaborator OTHER

• CHR Verviers

  collaborator UNKNOWN

• Virga Jesse Hasselt

  collaborator UNKNOWN

• Damiaanziekenhuis Oostende

  collaborator UNKNOWN

• AZ Sint-Lucas Brugge

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Marc Ferrante, MD PhD · Universitaire Ziekenhuizen KU Leuven

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-27

Primary Completion

2016-12-31

Completion

2018-05-31