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

An observational study of Crohn's Disease and Ulcerative Colitis, run by Celltrion.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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) Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Crohn's Disease, Ulcerative Colitis
Type of treatment: Injection or infusion
How many people: 470 participants
Where: No sites listed yet
Study dates: 8 Dec 2014to 28 Feb 2020
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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).

About this study

Official title: An Observational, Prospective Cohort Study to Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

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

Read the detailed description

This is a longitudinal, observational, prospective cohort study to assess the safety and efficacy of Remsima™ in patients with IBD, who have active Crohn's disease (CD), fistulizing Crohn's disease (CD), or Ulcerative Colitis (UC). Patients will be included in this registry who are receiving treatment with 5 mg/kg of Remsima™ by IV infusion at weeks 0, 2, 6, and every 8 weeks thereafter in accordance with the product label. If a patient has been treated with infliximab prior to enrollment, his or her dosing schedule will be continued appropriately. Patients will undergo safety and efficacy assessments in accordance with routine medical practice. The decision to treat with RemsimaTM will be independent of the decision to enroll the patient in this registry.

Conditions: Crohn's Disease, Ulcerative Colitis
Medical subject headings: Crohn Disease, Colitis, Ulcerative

What participants receive

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

Study groups in NCT02326155
Study group	Role	What they receive
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.

What is being measured

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

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.
Measured: 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
A patient is considered as achieving clinical response according to CDAI-70 (or CDAI-100) if the patient has a reduction on CDAI score of 70 (or 100) points or more from the baseline value.
Measured: 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
A patient is considered as achieving clinical response according to PCDAI if the patient has a PCDAI score less than or equal to 30 points and a reduction on PCDAI score of 15 points or more from the baseline value.
Measured: 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
A patient is considered as achieving clinical response according to the number of draining fistulas if the patient has a reduction on the number of draining fistulas from the baseline value (over a period of ≥ 4 weeks) ≥ 50%.
Measured: 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.
A patient is considered as achieving clinical response according to total Mayo score if the patient has a reduction from baseline in total mayo score at least 3 points and at least 30%, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1. A patient is considered as achieving clinical response according to partial Mayo score if the patient has a reduction from baseline in partial mayo score at least 2 points, with an accompanying reduction in the subscore for rectal bleeding of at least 1 point, or an absolute subscore for rectal bleeding of 0 or 1.
Measured: 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
A patient is considered as achieving clinical response according to PUCAI if the patient has a reduction on PUCAI score of 20 points or more from the baseline value.
Measured: Every 6 months (months 6 - 18)

Timeline

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

8 Dec 201428 Feb 2020

First posted25 Dec 2014 (estimated)
Study start8 Dec 2014
Primary completion28 Feb 2020
Study completion28 Feb 2020

Why it stopped: Terminated

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 470 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02326155
Sponsor's protocol ID: CT-P13 4.3
Status last verified: Dec 2021
First submitted: 22 Dec 2014
Last updated: 21 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 34250583

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingPhase 1
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Enrolling by invitationPhase 4
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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational, Prospective Cohort Study to Evaluate the Safety and Efficacy of Remsima™ in Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)
ClinicalTrials.gov ID: NCT02326155
Acronym / sponsor ID: CT-P13 4.3
Conditions: Crohn's Disease, Ulcerative Colitis
Study type: Observational
Recruitment status: TerminatedReason stopped: Terminated
Enrolment: 470 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 8 Dec 2014 (actual)
Primary completion: 28 Feb 2020 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 25 Dec 2014 (estimated)
Results: Posted 21 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The study population will consist of at least 500 male and female patients with active CD, fistulizing active CD, and UC

Key inclusion criteria (6 listed)

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™.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI)
Time frame: Up to 5 years for each patient
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.

5 secondary outcomes

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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Every 6 months (months 6 - 18)

Results and safety

Results posted to the registry on 21 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remsima (CT-P13)	407	13
Switched to Remsima (CT-P13)	63	1

Primary outcome: Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI)

Time frame: Up to 5 years for each patient. Count of participants. Unit: Participants

Measure	Remsima (CT-P13) n = 407	Switched to Remsima (CT-P13) n = 63
Treatment-emergent Adverse Events (TEAEs) of Hepatitis B virus reactivation	0	0
Treatment-emergent Adverse Events of congestive heart failure	0	0
Treatment-emergent Adverse Events of opportunistic infections (excluding tuberculosis)	0	0
TEAEs of serious infections including sepsis (excl. opportunistic infections and TB	15	2
Treatment-emergent Adverse Events of tuberculosis (TB)	4	0
Treatment-emergent Adverse Events of serum sickness (delayed hypersensitivity reactions)	0	0
Treatment-emergent Adverse Events of haematologic reactions	36	8
Treatment-emergent Adverse Events of systemic lupus erythematosus/lupus-like syndrome	0	0

Population analysed: Safety analysis set, all patients who received at least one dose of study treatment. Intestinal or perianal abscess and bowel stenosis/stricture/obstruction events are only applicable for patients with moderate to severe active CD, fistulising active CD and paediatric severe active CD. Colon carcinoma/dysplasia is only applicable for patients with moderate to severe active UC and paediatric severe active UC. Paediatric malignancy is only applicable for paediatric patients.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the date the patient signed the informed consent form and until the end of study visit up to 5 years, an average of 26.345 months. .. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remsima (CT-P13)	53 of 407 (13%)	221 of 407 (54.3%)	5 of 407
Switched to Remsima (CT-P13)	10 of 63 (15.9%)	34 of 63 (54%)	0 of 63

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34250583Cheon 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pavel Svoboda principal investigator

Ostrava, Morvskoslezsky kraj, Czech Republic, 708 52

Questions about this trial

What is this clinical trial studying?

An observational study of Crohn's Disease and Ulcerative Colitis, run by Celltrion.

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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 21 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) (time frame: Up to 5 years for each patient). 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 NCT02326155, which also lists 1 linked publication.

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 21 Feb 2022.