To Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

NCT02326155 | Terminated Results

• 1 other identifier: CT-P13 4.3
• Study Type: observational
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief Summary

An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)

Conditions

Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI)

  Including Hepatitis B virus (HBV) reactivation, congestive heart failure, opportunistic infections (excluding tuberculosis), serious infections including sepsis (excluding opportunistic infections and tuberculosis), tuberculosis (TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, lymphoma (not hepatosplenic T cell lymphoma), hepatobiliary events, hepatosplenic T cell lymphoma, intestinal or perianal abscess (in Crohn's disease), serious infusion reactions during a re-induction regimen following disease flare, sarcoidosis/sarcoid-like reactions, paediatric malignancy, leukaemia, malignancy (excluding lymphoma), colon carcinoma/dysplasia (in Ulcerative Colitis), skin cancer, pregnancy exposure, bowel stenosis/stricture/obstruction (in Crohn's disease) and infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction.

  Up to 5 years for each patient

Secondary Outcomes (5)

• Number and Percentage of Patients Achieving Clinical Response, Decrease of ≥70 Points From Baseline Scores in Crohn's Disease Activity Index-70 (CDAI-70) and Decrease of ≥100 Points From Baseline Scores in CDAI-100

  Every 6 months (months 6 -60)

• Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Crohn's Disease Activity Index (PCDAI) ≥15 Points; Total Score ≤30

  Every 6 months (months 6 -42)

• Number and Percentage of Patients Achieving Clinical Response, a ≥50% Reduction From Baseline in the Number of Draining Fistulas Over a Period of ≥4 Weeks Compared to Baseline

  Every 6 months (months 6 -48)

• Decrease in Mayo Scores From Baseline at Least 3 Points and 30% for Total or Decrease in Scores From Baseline at Least 2 Points for Partial, With Accompanying Decrease in Subscore for Rectal Bleeding of at Least 1 Point, or Absolute Subscore 0 or 1.

  Every 6 months (months 6 - 60)

• Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score

  Every 6 months (months 6 - 18)

Study Arms (2)

Remsima™

Patients were not treated with infliximab before enrollment. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.

Switched to Remsima

Patients were treated with infliximab prior to enrollment of the study. Patients were administered CT-P13 5mg/kg by intravenous infusion at weeks 0, 2, and 6, and every 8 weeks thereafter.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of at least 500 male and female patients with active CD, fistulizing active CD, and UC

You may qualify if:

• Adult patients with moderate to severe active CD
• Children and adolescent patients, aged 6 to 17 years old with severe active CD
• Adult patients with fistulizing active CD
• Adult patients with moderate to severe active UC
• Female patients of childbearing potential who agree to use of adequate contraception to prevent pregnancy and continuation of contraceptive use for at least 6 months after their final dose of Remsima™.
• Patients (or legal guardian, if applicable) who are willing to give informed consent for long term follow-up including access to all medical records.

You may not qualify if:

• Patients with a history of hypersensitivity to infliximab
• Patients with a current or past history of chronic infection
• Patients with current diagnosis of Tuberculosis (TB) or severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or previously diagnosed with TB or severe or chronic infection, without sufficient documentation of complete resolution following treatment.
• Recent exposure to persons with active TB, or a positive test result for latent TB (determined by a positive interferon-γ release assay \[IGRA\] test, with a negative chest X-ray) at Screening
• Patients with moderate or severe heart failure (NYHA class III/IV).

Sponsors & Collaborators

• Celltrion: lead

Related Publications (1)

• Cheon JH, Nah S, Kang HW, Lim YJ, Lee SH, Lee SJ, Kim SH, Jung NH, Park JE, Lee YJ, Jeon DB, Lee YM, Kim JM, Park SH. Infliximab Biosimilar CT-P13 Observational Studies for Rheumatoid Arthritis, Inflammatory Bowel Diseases, and Ankylosing Spondylitis: Pooled Analysis of Long-Term Safety and Effectiveness. Adv Ther. 2021 Aug;38(8):4366-4387. doi: 10.1007/s12325-021-01834-3. Epub 2021 Jul 12.

  PMID: 34250583 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: JiWoong Lim
• Organization: Celltrion Inc

jiwoong.lim@celltrion.com

82-32-850-5702

Study Officials

• Pavel Svoboda

  Ostrava, Morvskoslezsky kraj, Czech Republic, 708 52

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: December 8, 2014
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: February 21, 2022
• Results First Posted: February 21, 2022

Record last verified: 2021-12