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Inflammatory Bowel DiseasesNCT03452501

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

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Hikma Pharmaceuticals LLC at 4 sites in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Infliximab
Type of treatment
Injection or infusion
How many people
157 participants
Where
4 sitesSaudi Arabia
Study dates
26 Aug 2018to 17 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited from approximately 6 sites in Saudi Arabia

Who may be able to join

  • - 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

Who cannot join

  • - 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
Show all 10Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

Saudi Arabia4 sites

  • King Abdulaziz University Hospital

    Jeddah

  • Prince Sultan Military Medical City

    Riyadh, 11159

  • King Abdullah International Medical Research Center

    Riyadh, 11426

  • King Saud Medical City

    Riyadh

Other trials in Saudi Arabia

About this study

Official 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

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.

Read the detailed description

A multicenter, observational, prospective, cohort study to assess the safety and effectiveness of biosimilar Infliximab (Remsima®) in newly diagnosed and in switched IBD patients diagnosed with active Crohn's disease (CD), fistulizing CD, or Ulcerative Colitis (UC). Each patient is expected to be treated for a total of 38 weeks if naive or 40 weeks if switched. The study duration will be between 46 and 48 weeks (up to 12 months). Follow-up is expected to end 8 weeks after the last treatment visit.

Being tested
Infliximab
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
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabDrug

    Also called Remsima®

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

Study groups in NCT03452501
Study groupRoleWhat they receive
Naïve groupNewly diagnosed patients
Receives: Drug: Infliximab
Switched groupPatients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®
Receives: Drug: Infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (6)

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

    Clinical response is defined by a decrease in CDAI score from baseline of at least 70 points (Response-70). Clinical remission score < 150 for naïve patients with CD

    Measured: Up to 12 months

  2. Proportion of switched patients with CD achieving disease control

    Disease control is defined as the absence of disease worsening, with worsening defined as increase in CDAI of 70 points or more from the qualifying score with a total score of 175 or more and an increase in CDAI of 35% or more from baseline, or the introduction of a new treatment for active CD

    Measured: Up to 12 months

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

    Clinical response is defined as reduction of at least 50% from baseline in the number of draining fistulas. Clinical remission is defined as the absence of draining fistulas

    Measured: Up to 12 months

  4. Proportion of switched patients with fistulizing CD achieving disease control

    Disease control is defined as no loss of response, with loss of response defined as the recrudescence of draining fistulas, the need for a change in medication for CD, the need for additional therapy for persistent or worsening luminal disease activity, the need for a surgical procedure for CD, or the discontinuation of study medication owing to a perceived lack of effectiveness

    Measured: Up to 12 months

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

    Clinical response is defined as a decrease in partial Mayo scores from baseline of 2 points or more and 30% or more, with an accompanying decrease in the subscore for rectal bleeding of 1 point or more, or an absolute subscore for rectal bleeding of 0 or 1). Clinical remission is defined as a total partial Mayo score of 2 points or less, with no individual sub-score of more than 1 point), Mucosal healing (assessed through endoscopy, and defined by Mayo endoscopic subscore of 1 point or less)

    Measured: Up to 12 months

  6. Proportion of switched patients with UC achieving disease control.

    Disease control is defined as the absence of disease worsening, with worsening defined by an increase in partial Mayo score of 3 points or more from baseline [before switching] and a partial Mayo score of 5 points or more).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2018
  2. Study start26 Aug 2018
  3. Primary completion17 Aug 2020
  4. Study completion17 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03452501
Sponsor's protocol ID
RMS-KSA-2016-03
Status last verified
Mar 2020
First submitted
26 Feb 2018
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Hikma Pharmaceuticals LLC at 4 sites in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) to Remsima® (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03452501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

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