Crohn's DiseasePhase 3NCT02096861
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
A Phase 3 study testing CT-P13 and Remicade in people with Crohn's Disease, run by Celltrion at 1 site in United States.
Trial summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- CT-P13 and Remicade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2014to 15 Feb 2017
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
Who cannot join
- Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
- Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nashville Medical Research Institute
Nashville, Tennessee, 37205
About this study
Official title: A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
- Conditions
- Crohn's Disease
- Being tested
- CT-P13, Remicade
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P13Biological
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
RemicadeBiological
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 - CT-P13 | Experimental | CT-P13 followed by CT-P13 from Week 30 Receives: Biological: CT-P13 |
| CT-P13 - Remicade | Active comparator | CT-P13 followed by Remicade from Week 30 Receives: Biological: CT-P13; Biological: Remicade |
| Remicade - Remicade | Active comparator | Remicade followed by Remicade from Week 30 Receives: Biological: Remicade |
| Remicade - CT-P13 | Experimental | Remicade followed by CT-P13 from Week 30 Receives: Biological: CT-P13; Biological: Remicade |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
Measured: at Week 6
Secondary outcomes (7)
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Measured: Week 30
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.
Measured: Week 54
The Number and Percentage of Patients Achieving Clinical Remission at Week 6
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Measured: Week 6
The Number and Percentage of Patients Achieving Clinical Remission at Week 30
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Measured: Week 30
The Number and Percentage of Patients Achieving Clinical Remission at Week 54
Clinical remission was defined as an absolute CDAI score of less than 150 points.
Measured: Week 54
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.
Higher values of SIBDQ represent a better patient disease outcome.
Measured: Up to Week 30
The Short Inflammatory Bowel Disease Questionnaire
SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.
Higher values of SIBDQ represent a better patient disease outcome.
Measured: Baseline and Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study start19 Sep 2014
- Primary completion11 Jan 2016
- Study completion15 Feb 2017
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 (5)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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096861
- Sponsor's protocol ID
- CT-P13 3.4
- Other IDs
- 2013-004497-10
- Status last verified
- Mar 2018
- First submitted
- 24 Mar 2014
- Last updated
- 9 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
PubMed 35435862Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
PubMed 34216825Wong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242.
PubMed 33245751Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.
PubMed 30929895Husereau D, Feagan B, Selya-Hammer C. Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching. Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0.
PubMed 29411318
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
- ClinicalTrials.gov ID
- NCT02096861
- Acronym / sponsor ID
- CT-P13 3.4
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 11 Jan 2016 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Posted 11 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CT-P13 - CT-P13 | Experimental | Biological: CT-P13CT-P13 followed by CT-P13 from Week 30 |
| CT-P13 - Remicade | Active comparator | Biological: CT-P13, Biological: RemicadeCT-P13 followed by Remicade from Week 30 |
| Remicade - Remicade | Active comparator | Biological: RemicadeRemicade followed by Remicade from Week 30 |
| Remicade - CT-P13 | Experimental | Biological: CT-P13, Biological: RemicadeRemicade followed by CT-P13 from Week 30 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
Key exclusion criteria (2 listed)
- Patient who has previously received a biological agent for the treatment of Crohn's disease and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other disease.
- Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P13CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | Biological | CT-P13 - CT-P13, CT-P13 - Remicade, Remicade - CT-P13 |
| RemicadeRemicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose | Biological | CT-P13 - Remicade, Remicade - CT-P13, Remicade - Remicade |
Primary outcome
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6
Time frame: at Week 6
A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.
7 secondary outcomes
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
Time frame: Week 30
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
Time frame: Week 54
The Number and Percentage of Patients Achieving Clinical Remission at Week 6
Time frame: Week 6
The Number and Percentage of Patients Achieving Clinical Remission at Week 30
Time frame: Week 30
The Number and Percentage of Patients Achieving Clinical Remission at Week 54
Time frame: Week 54
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: Up to Week 30
The Short Inflammatory Bowel Disease Questionnaire
Time frame: Baseline and Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35435862Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
- Derived from this study: PubMed 34216825Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
- Derived from this study: PubMed 33245751Wong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242.
- Derived from this study: PubMed 30929895Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.
- Derived from this study: PubMed 29411318Husereau D, Feagan B, Selya-Hammer C. Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching. Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P13 and Remicade in people with Crohn's Disease, run by Celltrion at 1 site in United States.
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 1 inclusion and 2 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2018). 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?
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (time frame: at Week 6). 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 NCT02096861, which also lists 5 linked publications.
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 9 May 2018.