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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 March 2021
• Main ID: NCT03452501
• Date of registration: 26/02/2018
• Prospective Registration: Yes
• Primary sponsor: Hikma Pharmaceuticals LLC
• Public title: Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients
• Scientific title: An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD
• Date of first enrolment: August 26, 2018
• Target sample size: 157
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03452501
• Study type: Observational

Countries of recruitment

Saudi Arabia

Key inclusion & exclusion criteria

Inclusion Criteria:

- - 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

Exclusion Criteria:

- - 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-? 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-a) 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Crohn Disease

Inflammatory Bowel Diseases

Fistulizing Crohn's Disease

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Incidence of adverse events (AEs) to Remsima® [Time Frame: 12 months]

Secondary Outcome(s)

Proportion of naïve patients with UC achieving clinical response or remission based on Partial Mayo Score and mucosal healing [Time Frame: Up to 12 months]

Proportions of naïve patients with CD achieving clinical response or remission based on Crohn's Disease Activity Index (CDAI) [Time Frame: Up to 12 months]

Proportion of naïve patients with fistulizing CD achieving clinical response or remission [Time Frame: Up to 12 months]

Proportion of switched patients with UC achieving disease control. [Time Frame: Up to 12 months]

Proportion of switched patients with CD achieving disease control [Time Frame: Up to 12 months]

Proportion of switched patients with fistulizing CD achieving disease control [Time Frame: Up to 12 months]

Secondary ID(s)

RMS-KSA-2016-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors