EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

NCT03679546 | Completed Phase 4

• 3 other identifiers: 35RC17_8841_EFFICACI2018-002673-212018-66-PP
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 19

Brief Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades. However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up. Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue. Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Remission

  The rate of patients with clinical and endoscopic steroid free-remission (Mayo score ≤ 2 without subscore \> 1) at week 14

  Week 14

Secondary Outcomes (13)

• Mayo score

  Week 54

• Faecal calprotectin level

  At week 14 and 54

• Colectomy or hospitalization for disease flare

  through study completion, an average of 1 year

• Endoscopic subscore of the mayo Score

  at week 14 and 54

• Partial Mayo score

  at week 2, 6, 14, 54

Study Arms (2)

Infliximab

EXPERIMENTAL

Infliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks.

Drug: Infliximab

Vedolizumab

EXPERIMENTAL

Vedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks.

Drug: Vedolizumab Injection

Interventions

Infliximab DRUG

Infliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks.

Also known as: Infliximab injection

Infliximab

Vedolizumab Injection DRUG

Vedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks.

Also known as: Vedolizumab

Vedolizumab

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female, non-lactating female;
• years of age or older and less than 75 years ;
• Documented diagnosis of UC for at least 6 months ;
• Left side colitis or pancolitis ;
• Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
• Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ;
• Ability of the subject to participate fully in all aspects of this clinical trial ;
• Written informed consent must be obtained and documented ;
• Naïve to Janus kinase inhibitor (JAK inhibitor) ;
• Affiliation to the national health insurance.
• Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ;
• Contraindication to vedolizumab treatment ;
• Steroid treatment \> 20 mg/day for at least two weeks before baseline ;
• Proctitis ;
• Stoma ;

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (19)

Centre Hospitalier Universitaire d'Amiens-Picardie

Amiens, 80054, France

Location

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33600, France

Location

Centre Hospitalier Universitaire de Caen

Caen, 14033, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon

Clichy, 92110, France

Location

Assistance Publique des Hôpitaux de Paris - Hôpital Henri Mondor

Créteil, 94000, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59037, France

Location

Hospices Civils de Lyon

Lyon, 69495, France

Location

Assistance Publique des Hôpitaux de Marseille

Marseille, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34090, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, 54500, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06202, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, France

Location

Assistance Publique des Hôpitaux de Paris - Hôpital Saint-Louis

Paris, 75010, France

Location

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, 22000, France

Location

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab; vedolizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Guillaume BOUGUEN, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator will proceed to the patient randomization as follows : * The investigator fulfill the electronic case report form (eCRF) * The randomization will be performed through the eCRF. * A mail will be sent to the pharmacy that included the inclusion number of the patient, the group allocated and the dose of infliximab or vedolizumab to be infused. * A mail will be sent to the investigator that included only the inclusion number of the patient. The trial is conducted in a double-blind manner. The biostatistician who generated the randomization list, the person in charge of pharmacovigilance, the pharmacy of the clinical trials of the Rennes university hospital and the pharmacist of the recruiting center can have access to the arm of treatment under study. Patients and physicians will not know the nature of the molecules administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, multicenter, randomized, double blind clinical trial

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 20, 2018
• Study Start: January 4, 2019
• Primary Completion: December 16, 2024
• Study Completion: June 16, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)