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

NCT02914717 | Completed

• 1 other identifier: S59335
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

golimumab

Outcome Measures

Primary Outcomes (1)

• Steroid-free clinical response at week 26

  Percentage of participants with steroid-free clinical response at week 26 Clinical response was defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the sub-score for rectal bleeding of at least 1 point or an absolute sub-score for rectal bleeding of 0 or 1

  Week 26

Secondary Outcomes (16)

• Golimumab continuation at week 26

  Week 26

• (Steroid-free) Clinical remission at week 14

  Week 14

• (Steroid-free) Clinical remission at week 26

  Week 26

• (Steroid-free) Clinical remission at week 52

  Week 52

• (Steroid-free) Clinical response at week 14

  Week 14

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred patients who participated to the SMART study (EudraCT 2014-000656-29), with moderate-to-severe ulcerative colitis, who are either anti-TNF naïve or who previously failed infliximab therapy, and previously did not perform self-injection for any indication

You may qualify if:

• At least 18 years of age
• Established diagnosis of UC for at least 3 months
• Moderate-to-severe ulcerative colitis (Mayo score ≥ 6, including endoscopic sub-score ≥ 2)
• Previous conventional therapy for a period of at least 3 months with aminosalicylates and at least 3 months with corticosteroids or 6-mercaptopurine (6-MP) or azathioprine (AZA), unless the participant is intolerant to, or has contraindications to these treatments
• The patients should be
• Anti-tumour necrosis factor (anti-TNF) naive participants, OR
• Anti-TNF experienced, either not responding, partially responding, or intolerant to treatment with infliximab
• Sexually active women of child-bearing potential must agree to use a medically accepted method of contraception while receiving study drug and for 6 months after the stop of study drug
• Willing and able to provide written informed consent

You may not qualify if:

• Has a history of prior self-injection of any agent for any reason
• Diagnosis of inflammatory bowel disease (IBD) type unclassified or Crohn's disease
• Previous (procto)colectomy for ulcerative colitis
• Patients with an ostomy
• Previous therapy with adalimumab
• Patients with acute severe IV steroid refractory colitis
• Concomitant use of other biologic agents
• Active tuberculosis (TB) within 12 months prior to the first injection or has suspected latent TB as indicated by a positive tuberculin skin test or Interferon gamma (IFNγ) release assay. In case of latent TB, a pneumologist should be contacted and the patient should be treated prophylactically
• Active clinical non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis jiroveci, aspergillosis), within 6 months prior to the first injection
• Active infection and/or serious infection (e.g. HIV, hepatitis, pneumonia, pyelonephritis, severe sepsis) within 6 months prior to the first study drug administration
• Live viral or bacterial vaccination within 3 months prior to the first study injection or Bacillus Calmette-Guerin vaccination within 12 months prior to the first study drug injection
• Evidence of heart failure of New York Heart Association (NYHA) class 3-4
• History of demyelinating disease such as multiple sclerosis or optic neuritis
• History of systemic lupus erythematosus
• History of lymphoproliferative disease, or any unknown malignancy or history of malignancy within the prior 5 years, with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW: collaborator
• Imelda Hospital, Bonheiden: collaborator
• AZ Delta: collaborator
• University Hospital, Ghent: collaborator
• University Hospital, Antwerp: collaborator
• Ziekenhuis Oost-Limburg: collaborator
• Onze Lieve Vrouw Hospital: collaborator
• General Hospital Groeninge: collaborator
• University of Liege: collaborator
• Clinique Saint Joseph, Liège: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Erasme University Hospital: collaborator
• Chwapi Tournai: collaborator
• AZ Jan Palfijn Gent: collaborator
• CHR Verviers: collaborator
• Virga Jesse Hasselt: collaborator
• Damiaanziekenhuis Oostende: collaborator
• AZ Sint-Lucas Brugge: collaborator

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Ferrante, MD PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: September 26, 2016
• Study Start: April 27, 2016
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2018
• Last Updated: June 27, 2024

Record last verified: 2017-10