Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients

NCT03452501 | Completed

• 1 other identifier: RMS-KSA-2016-03
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the daily practice will be performed.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Fistulizing Crohn's Disease; Ulcerative Colitis

Keywords

Infliximab; Remsima; Biosimilar; Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis; Fistulizing Crohn's Disease; Observational; Follow up; Safety; Effectiveness; Disease modifying anti-rheumatic drugs; Tumor necrosis factor-alpha inhibitors

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs) to Remsima®

  Number, type, severity and frequency of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests (according to laboratory reference ranges), in addition to the incidence of latent tuberculosis (TB) activation (as an adverse event) and the incidence of hepatitis B virus HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) will be assessed

  12 months

Secondary Outcomes (6)

• Proportions of naïve patients with CD achieving clinical response or remission based on Crohn's Disease Activity Index (CDAI)

  Up to 12 months

• Proportion of switched patients with CD achieving disease control

  Up to 12 months

• Proportion of naïve patients with fistulizing CD achieving clinical response or remission

  Up to 12 months

• Proportion of switched patients with fistulizing CD achieving disease control

  Up to 12 months

• Proportion of naïve patients with UC achieving clinical response or remission based on Partial Mayo Score and mucosal healing

  Up to 12 months

Study Arms (2)

Naïve group

Newly diagnosed patients

Drug: Infliximab

Switched group

Patients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®

Drug: Infliximab

Interventions

Infliximab DRUG

A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg

Also known as: Remsima®

Naïve group; Switched group

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

Patients will be recruited from approximately 6 sites in Saudi Arabia

You may qualify if:

• \- Adult patients with moderate to severe active CD who have not responded despite a full and adequate course of therapy with corticosteroids and/or immunosuppressive agents, or who are intolerant to or have medical contraindications to such therapies.
• Adult patients with fistulizing active CD who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
• Adult patients with moderate to severe active UC who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant or have medical contraindications to such therapies.
• Switched patients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®.
• Patients who agree to join the study and give a written informed consent

You may not qualify if:

• \- Patients with a known history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients (Sucrose, Polysorbate 80, Monobasic sodium phosphate and/or Dibasic sodium phosphate).
• Patients who have shown intolerance or inefficacy to biologics for IBD treatment.
• Female patients who are known to be pregnant or breastfeeding.
• Patients with a past or present history of chronic infection with Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV), or those with positive test at screening.
• Patients who are diagnosed with tuberculosis (TB) or previously diagnosed with TB with no evidence of complete resolution
• Patients with severe or chronic infections (e.g. sepsis, abscesses, opportunistic infections, invasive fungal infections), or severe or chronic infection, without sufficient documentation of complete resolution following treatment
• Patients with recent exposure to persons with active TB, or a positive test result for latent TB at Screening. A patient who has received at least the first 30 days or recommended period of country-specific TB prophylactic therapy and intends to complete the entire course of therapy may be enrolled. Recommended methods to screening latent TB are interferon-γ release assay \[IGRA\] test, with a chest X-ray, however, other methods could be used according to local guideline.
• Patients with moderate or severe heart failure (New York Heart Association NYHA class III/IV).
• Patients for whom the treatment with Tumor necrosis factor-alpha (TNF-α) blockers is concerning due to a history of malignancy within the previous five years prior to enrollment or a history of herpes zoster within one month prior to enrollment, may be excluded at the investigator's discretion.
• Patients who meet any of the contraindications to the administration of infliximab

Sponsors & Collaborators

• Hikma Pharmaceuticals LLC: lead

Study Sites (4)

King Abdulaziz University Hospital

Jeddah, Saudi Arabia

Location

Prince Sultan Military Medical City

Riyadh, 11159, Saudi Arabia

Location

King Abdullah International Medical Research Center

Riyadh, 11426, Saudi Arabia

Location

King Saud Medical City

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; CT-P13

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: August 26, 2018
• Primary Completion: August 17, 2020
• Study Completion: August 17, 2020
• Last Updated: February 23, 2021

Record last verified: 2020-03

Locations

SA (4)