Crohn's DiseasePhase 1NCT02883452
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
A Phase 1 study testing CT-P13 in people with Crohn's Disease and Ulcerative Colitis (Part 2 Only), run by Celltrion at 1 site in South Korea.
Trial summary
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis (Part 2 Only)
- What is being tested?
- CT-P13
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Sep 2016to 2 Oct 2019
- Phase
- Phase 1
- 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
- Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points.
- Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).
Who cannot join
- Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease
- Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product
- Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled)
- Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug
- Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
Read the detailed description
A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.
- Conditions
- Crohn's Disease, Ulcerative Colitis (Part 2 Only)
- Being tested
- CT-P13
- 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.
CT-P13Biological
Also called Infliximab
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
CT-P13Biological
Also called Infliximab
CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)
CT-P13Biological
Also called Infliximab
CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)
CT-P13Biological
Also called Infliximab
CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)
CT-P13Biological
Also called Infliximab
CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)
CT-P13Biological
Also called Infliximab
CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: CT-P13 IV 5 mg/kg | Active comparator | CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks (Part 1) Receives: Biological: CT-P13 |
| Cohort 2: CT-P13 SC 120 mg | Experimental | CT-P13 SC (Infliximab), 120 mg by SC injection every 2 weeks (Part 1) Receives: Biological: CT-P13 |
| Cohort 3: CT-P13 SC 180 mg | Experimental | CT-P13 SC (Infliximab), 180 mg by SC injection every 2 weeks (Part 1) Receives: Biological: CT-P13 |
| Cohort 4: CT-P13 SC 240 mg | Experimental | CT-P13 SC (Infliximab), 240 mg by SC injection every 2 weeks (Part 1) Receives: Biological: CT-P13 |
| Arm 1: CT-P13 SC 120/240 mg | Experimental | CT-P13 SC (Infliximab), either 120 mg or 240 mg every 2 weeks by SC injection (Part 2) Receives: Biological: CT-P13 |
| Arm 2: CT-P13 IV 5 mg/kg | Active comparator | CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks up to Week 22. CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC (Infliximab) treatment, and further doses with CT-P13 SC were given up to Week 54. (Part 2) Receives: Biological: CT-P13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Measured: Week 22, 24, 26 and 28
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
Measured: Week 22
Secondary outcomes (6)
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of CDAI score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components multiplied by the relevant weight factor; number of liquid or very soft stools (x2), abdominal pain (x5), general well-being (x7), CD complications (x20), taking lomotil/opiates for diarrhea (x30), abdominal mass (x10), deviation of hematocrit (x6), and percentage deviation from standard weight (x1). Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Measured: up to Week 54
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to CDAI-100 criteria up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active CD patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to CDAI-100 criteria was defined as a decrease in CDAI score of 100 points or more from the baseline value.
Measured: up to Week 54
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as descriptive statistics for actual value of partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. The partial Mayo scores range from 0-9 with higher scores indicating increased severity of disease. The index is sum of the 3 subscores, each which range from 0 to 3; stool frequency, rectal bleeding and physician's global assessment. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Measured: up to Week 54
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
For evaluation of efficacy, the secondary endpoint was defined as proportion of patients achieving clinical response according to the partial Mayo score up to Week 54 between the CT-P13 SC and CT-P13 IV treatment groups in active UC patients. Efficacy assessments were done prior to each study drug administrations. Results up to Week 6 in both arms represent efficacy resulting from CT-P13 IV (5 mg/kg) loading dose treatment.
Responder according to partial Mayo score was defined as a decrease from baseline in partial Mayo score of at least 2 points, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1.
Measured: up to Week 54
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
For evaluation of pharmacokinetics (PK), the secondary endpoint was defined as the analysis of trough concentration of infliximab up to Week 54. The samples were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. During PK monitoring visit (Weeks 22-30), samples were collected every 2 weeks according steady state PK sampling time point. All enrolled patient received CT-P13 IV infusions at Weeks 0 and 2. Patients in SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22. Then, CT-P13 IV was switched to CT-P13 SC at Week 30, and further doses with CT-P13 SC were given up to Week 54. No PK results were obtained at Weeks 6 and 14 for SC group and Weeks 12, 20, 24, 26 and 28 for IV group due to 2 weeks and 8 weeks dosing interval, respectively. All patients in PK population were analyzed according to the treatment they received.
Measured: up to Week 54
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
For evaluation of pharmacodynamic (PD), the secondary endpoint was defined as concentration of Fecal Calprotectin (FC) between 2 treatment groups up to Week 54. The fecal samples for FC were collected at Weeks 0, 2 and 6, and every 8 weeks up to Week 54. All enrolled patients received CT-P13 IV infusions at Weeks 0 and 2. Then, patients in CT-P13 SC group were administered with CT-P13 SC at Week 6 and every 2 weeks thereafter up to Week 54. Patients in the CT-P13 IV group were administered with CT-P13 IV at Week 6 and every 8 weeks thereafter up to Week 22 (Weeks 14 and 22). And then, CT-P13 IV was switched to CT-P13 SC based on body weight at Week 30, and further doses with CT-P13 SC were given up to Week 54. All patients in the PD population were analyzed according to the treatment they received.
Measured: up to Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start29 Sep 2016
- Primary completion4 Feb 2019
- Study completion2 Oct 2019
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 (3)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MoonSun Choi, Study director, Celltrion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883452
- Sponsor's protocol ID
- CT-P13 1.6 (SC)
- Other IDs
- 2016-002124-89, 2016
- Status last verified
- May 2020
- First submitted
- 25 Aug 2016
- Last updated
- 9 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Schreiber S, D'Haens G, Cummings F, Irving PM, Ye BD, Ben-Horin S, Kim DH, Jeong AL, Reinisch W. Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial. Dig Liver Dis. 2024 Jul;56(7):1204-1212. doi: 10.1016/j.dld.2023.12.013. Epub 2024 Feb 15.
PubMed 38365502D'Haens G, Reinisch W, Schreiber S, Cummings F, Irving PM, Ye BD, Kim DH, Yoon S, Ben-Horin S. Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial. Clin Drug Investig. 2023 Apr;43(4):277-288. doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1.
PubMed 37004656Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.
PubMed 33676969
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02883452
- Acronym / sponsor ID
- CT-P13 1.6 (SC)
- Conditions
- Crohn's Disease, Ulcerative Colitis (Part 2 Only)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2016 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 2 Oct 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).
Detailed description
A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: CT-P13 IV 5 mg/kg | Active comparator | Biological: CT-P13CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks (Part 1) |
| Cohort 2: CT-P13 SC 120 mg | Experimental | Biological: CT-P13CT-P13 SC (Infliximab), 120 mg by SC injection every 2 weeks (Part 1) |
| Cohort 3: CT-P13 SC 180 mg | Experimental | Biological: CT-P13CT-P13 SC (Infliximab), 180 mg by SC injection every 2 weeks (Part 1) |
| Cohort 4: CT-P13 SC 240 mg | Experimental | Biological: CT-P13CT-P13 SC (Infliximab), 240 mg by SC injection every 2 weeks (Part 1) |
| Arm 1: CT-P13 SC 120/240 mg | Experimental | Biological: CT-P13CT-P13 SC (Infliximab), either 120 mg or 240 mg every 2 weeks by SC injection (Part 2) |
| Arm 2: CT-P13 IV 5 mg/kg | Active comparator | Biological: CT-P13CT-P13 IV (Infliximab), 5 mg/kg by IV infusion every 8 weeks up to Week 22. CT-P13 IV was switched to either 120 mg or 240 mg of CT-P13 SC (Infliximab) treatment, and further doses with CT-P13 SC were given up to Week 54. (Part 2) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has active Crohn's disease with a score on the Crohn's disease activity index between 220 and 450 points.
- Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and 12 points (Part 2 only).
Key exclusion criteria (5 listed)
- Patient who has previously received a biological agent for the treatment of CD and UC and/or a tumor necrosis factor-alpha (TNFα) inhibitor for the treatment of other disease
- Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product
- Patient who has a current or past history of infection with HIV, hepatitis B, or hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into the study, but past hepatitis B resolved can be enrolled)
- Patient who has acute infection requiring oral antibiotics within 2 weeks or parenteral injection of antibiotics within 4 weeks prior to the first administration of the study drug, other serious infection within 6 months prior to the first administration of study drug or recurrent herpes zoster or other chronic or recurrent infection within 6 weeks prior to the first administration of the study drug
- Patient who has an indeterminate result for interferon-γ release assay (IGRA) or latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at Screening, 1 retest will be possible during the screening. If the repeated IGRA result is negative, the patient can be included in the study.
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-P13Also: InfliximabCT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1) | Biological | Cohort 1: CT-P13 IV 5 mg/kg |
| CT-P13Also: InfliximabCT-P13 (120 mg) by single SC injection every 2 weeks (Part 1) | Biological | Cohort 2: CT-P13 SC 120 mg |
| CT-P13Also: InfliximabCT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1) | Biological | Cohort 3: CT-P13 SC 180 mg |
| CT-P13Also: InfliximabCT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1) | Biological | Cohort 4: CT-P13 SC 240 mg |
| CT-P13Also: InfliximabCT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2) | Biological | Arm 1: CT-P13 SC 120/240 mg |
| CT-P13Also: InfliximabCT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2) | Biological | Arm 2: CT-P13 IV 5 mg/kg |
Primary outcome
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1)
Time frame: Week 22, 24, 26 and 28
For Part 1, the primary PK endpoint of the AUCτ at steady state between Week 22 and Week 30 was analyzed in patients who received all doses (full) of study drug up to Week 30 (prior to Week 30) in the PK population. All patients in SC cohorts were randomly assigned at Week 14 in a 1:1 ratio to either of Group A or B for PK monitoring visit period (Week 22 to Week 30). Therefore, AUCτ was calculated at Week 22 for Cohort 1: CT-P13 IV 5 mg/kg, Weeks 22 and 26 for Group A of SC cohorts, and Week 24 and 28 for Group B of SC cohorts.
Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
Time frame: Week 22
For Part 2, the primary endpoint was to demonstrate that CT-P13 SC is non-inferior to CT-P13 IV, in terms of pharmacokinetics, as determined by the observed Ctrough,week22 (pre-dose level at Week 22).
6 secondary outcomes
Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
Time frame: up to Week 54
Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
Time frame: up to Week 54
Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
Time frame: up to Week 54
Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
Time frame: up to Week 54
Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
Time frame: up to Week 54
Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
Time frame: up to Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38365502Schreiber S, D'Haens G, Cummings F, Irving PM, Ye BD, Ben-Horin S, Kim DH, Jeong AL, Reinisch W. Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial. Dig Liver Dis. 2024 Jul;56(7):1204-1212. doi: 10.1016/j.dld.2023.12.013. Epub 2024 Feb 15.
- Derived from this study: PubMed 37004656D'Haens G, Reinisch W, Schreiber S, Cummings F, Irving PM, Ye BD, Kim DH, Yoon S, Ben-Horin S. Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial. Clin Drug Investig. 2023 Apr;43(4):277-288. doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1.
- Derived from this study: PubMed 33676969Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.
- Individual participant dataSharing planned: No
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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.
MoonSun Choi study director
Celltrion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-P13 in people with Crohn's Disease and Ulcerative Colitis (Part 2 Only), run by Celltrion at 1 site in South Korea.
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 2 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: finished, as of the sponsor's last update on 9 Jun 2020. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 9 Jun 2020). 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?
Descriptive Statistics of Area Under the Concentration-time Curve (AUCτ) of Infliximab at Steady State (Part 1) (time frame: Week 22, 24, 26 and 28). The study lists 2 primary outcomes in all. 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 NCT02883452, which also lists 3 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 Jun 2020.