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NCT Number: NCT05722353

IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®

CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes.

About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response

Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Antoine Hospital Service de Gastroentérologie et Nutrition

Paris, 75012, France

About this study

The study assesses in real-life setting the IBD disease course of infliximab-naïve IBD patients treated with subcutaneous infliximab. This study will look at the clinical and biological outcomes of people who take subcutaneous infliximab.

The study will enroll approximately 120 participants with an indication for iv infliximab.

All participants will receive 1 intravenous infusion on Day 1 and Week 2, followed by 1 SC injection on Week 6 and then 1 SC injection every 2 weeks for up to Week 48.

Switch to subcutaneous infliximab (Remsima® SC) at week 6 will be proposed as part of standard of care.

This multi-center trial will be conducted in hospitals of Assistance Publique - Hôpitaux de Paris (AP-HP). The overall time to participate in this study is 48 weeks. Participants will make approximately 5 visits to the clinic.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Crohn's disease or ulcerative colitis (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
  • Starting infliximab as standard of care (originator or biosimilars)
  • with or without concomitant immunosuppressive agent and/or steroids use at infliximab initiation
  • Patients agreeing to participate

Exclusion criteria

  • Patients not eligible to infliximab according to standard of care screening
  • Previous exposure to infliximab: originator or biosimilars
  • Participation in another interventional study
  • No coverage by the French health insurance

Treatment and study plan

Biocollection

Other

Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Primary outcomes

  1. Steroids Steroid-free clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150 in patients with CD

    Time frame: week 48

  2. Steroids Steroid-free clinical remission defined as Simple clinical colitis activity index (SCCAI) < 3 in patients with UC

    Time frame: week 48

Secondary outcomes

  1. Clinical response defined as a decrease in CDAI ≥100 from the baseline CDAI score in patients with CD

    Time frame: Week 48

  2. Clinical response defined as a decrease in SCCAI ≥ 3 from the baseline SCCAI score in patients with UC

    Time frame: Week 48

  3. Biological remission

    Time frame: Week 48

    Biological remission is based on CRP level < 5mg/dL

  4. Percentage of patients who switch back to IV infliximab

    Time frame: Week 48

    Percentage of patients who switch back to IV infliximab

  5. clinical relapse-free rates

    Time frame: Week 48

    Relapse will be based on physician global assessment

  6. loss of response rates

    Time frame: Week 48

    loss of response rates at week 48

  7. clinical remission

    Time frame: Week 12

    clinical response and remission

  8. Mean change from baseline in CDAI score in patients with CD

    Time frame: Week 48

  9. Mean change from baseline in SCCAI score in patients with UC

    Time frame: Week 48

  10. Mean change from baseline in CRP

    Time frame: Week 48

  11. Mean change from baseline in fecal calprotectin

    Time frame: Week 48

  12. infliximab through levels

    Time frame: Week 48

  13. Development of anti-infliximab antibodies

    Time frame: Week 48

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PRIME

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2023
Registry last updated
Apr 2, 2025

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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