- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03452501
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients
February 22, 2021 updated by: Hikma Pharmaceuticals LLC
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
157
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jeddah, Saudi Arabia
- King AbdulAziz University Hospital
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Riyadh, Saudi Arabia, 11426
- King Abdullah International Medical Research Center
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Riyadh, Saudi Arabia, 11159
- Prince Sultan Military Medical City
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Riyadh, Saudi Arabia
- King Saud Medical City
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients will be recruited from approximately 6 sites in Saudi Arabia
Description
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-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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Naïve group
Newly diagnosed patients
|
A vial containing powder for concentrate for solution for infusion.
Each vial contains: Infliximab 100 mg
Other Names:
|
Switched group
Patients who received at least one dose of Infliximab reference medicinal product (RMP) before the first infusion of Remsima®
|
A vial containing powder for concentrate for solution for infusion.
Each vial contains: Infliximab 100 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs) to Remsima®
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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Up to 12 months
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Proportion of switched patients with CD achieving disease control
Time Frame: Up to 12 months
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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
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Up to 12 months
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Proportion of naïve patients with fistulizing CD achieving clinical response or remission
Time Frame: Up to 12 months
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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
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Up to 12 months
|
Proportion of switched patients with fistulizing CD achieving disease control
Time Frame: Up to 12 months
|
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
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Up to 12 months
|
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
|
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)
|
Up to 12 months
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Proportion of switched patients with UC achieving disease control.
Time Frame: Up to 12 months
|
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).
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Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 26, 2018
Primary Completion (Actual)
August 17, 2020
Study Completion (Actual)
August 17, 2020
Study Registration Dates
First Submitted
February 26, 2018
First Submitted That Met QC Criteria
February 26, 2018
First Posted (Actual)
March 2, 2018
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RMS-KSA-2016-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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