Crohn's Disease, Ulcerative Colitis
Conditions
Brief 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)
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.
Interventions
None listed
Sponsors
Celltrion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Every 6 months (months 6 -60) | 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. |
| 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 | Every 6 months (months 6 -42) | 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. |
| 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 | Every 6 months (months 6 -48) | 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%. |
| 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. | Every 6 months (months 6 - 60) | 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. |
| Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | Every 6 months (months 6 - 18) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remsima (CT-P13) 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. | 407 |
| Switched to Remsima (CT-P13) 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. | 63 |
| Total | 470 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 21 | 5 |
| Overall Study | Death | 3 | 0 |
| Overall Study | Disease progression | 37 | 4 |
| Overall Study | except for study close | 46 | 13 |
| Overall Study | Lack of Efficacy | 49 | 5 |
| Overall Study | Lost to Follow-up | 14 | 3 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Study close | 188 | 21 |
| Overall Study | Withdrawal by Subject | 34 | 11 |
Baseline characteristics
| Characteristic | Remsima (CT-P13) | Switched to Remsima (CT-P13) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 52 Participants | 18 Participants | 70 Participants |
| Age, Categorical >=65 years | 21 Participants | 1 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 334 Participants | 44 Participants | 378 Participants |
| Age, Continuous | 33 years | 27 years | 32 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 186 Participants | 30 Participants | 216 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 220 Participants | 33 Participants | 253 Participants |
| Sex: Female, Male Female | 169 Participants | 21 Participants | 190 Participants |
| Sex: Female, Male Male | 238 Participants | 42 Participants | 280 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 407 | 0 / 63 |
| other Total, other adverse events | 221 / 407 | 34 / 63 |
| serious Total, serious adverse events | 53 / 407 | 10 / 63 |
Outcome results
Primary
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.
Time frame: Up to 5 years for each patient
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events (TEAEs) of Hepatitis B virus reactivation | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of congestive heart failure | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of opportunistic infections (excluding tuberculosis) | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of serious infections including sepsis (excl. opportunistic infections and TB | 15 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of tuberculosis (TB) | 4 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of serum sickness (delayed hypersensitivity reactions) | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of haematologic reactions | 36 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of systemic lupus erythematosus/lupus-like syndrome | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of demyelinating disorders | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of lymphoma (not hepatosplenic T cell lymphoma) | 1 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of hepatobiliary events | 14 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of hepatosplenic T cell lymphoma | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of intestinal or perianal abscess (in Crohn's disease) | 7 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of serious infusion reactions during a re-induction regimen following disease flare | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of sarcoidosis/sarcoid-like reactions | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of paediatric malignancy | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of leukaemia | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of malignancy (excluding lymphoma) | 3 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of colon carcinoma/dysplasia (in Ulcerative Colitis) | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of skin cancer | 0 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of pregnancy exposure | 3 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of bowel stenosis/stricture/obstruction (in Crohn's disease) | 8 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction | 39 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of hepatosplenic T cell lymphoma | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events (TEAEs) of Hepatitis B virus reactivation | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of malignancy (excluding lymphoma) | 2 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of congestive heart failure | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of intestinal or perianal abscess (in Crohn's disease) | 1 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of opportunistic infections (excluding tuberculosis) | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of pregnancy exposure | 1 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of serious infections including sepsis (excl. opportunistic infections and TB | 2 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of serious infusion reactions during a re-induction regimen following disease flare | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of tuberculosis (TB) | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of colon carcinoma/dysplasia (in Ulcerative Colitis) | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of serum sickness (delayed hypersensitivity reactions) | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of sarcoidosis/sarcoid-like reactions | 1 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of haematologic reactions | 8 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | TEAEs of infusion related reaction (IRR)/ hypersensitivity/anaphylactic reaction | 4 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of systemic lupus erythematosus/lupus-like syndrome | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of paediatric malignancy | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of demyelinating disorders | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of skin cancer | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of lymphoma (not hepatosplenic T cell lymphoma) | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of leukaemia | 0 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of hepatobiliary events | 5 Participants |
| Switched to Remsima (CT-P13) | Number and Percentage of Patients Who Experienced Adverse Events of Special Interest (AESI) | Treatment-emergent Adverse Events of bowel stenosis/stricture/obstruction (in Crohn's disease) | 2 Participants |
Secondary
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.
Time frame: Every 6 months (months 6 - 60)
Population: Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 6 months | 18 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 12 months | 19 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 18 months | 13 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 24 months | 12 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 30 months | 15 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 36 months | 5 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 12 months | 30 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 18 months | 28 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 24 months | 22 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 30 months | 23 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 36 months | 19 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 42 months | 15 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 48 months | 14 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 54 months | 10 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 60 months | 2 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 42 months | 7 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 48 months | 6 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 54 months | 4 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 60 months | 1 Participants |
| Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 6 months | 35 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to total mayo score at 36 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 42 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 18 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 36 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 24 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 48 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 6 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 30 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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. | Clinical response according to partial mayo score at 12 months | 1 Participants |
Secondary
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%.
Time frame: Every 6 months (months 6 -48)
Population: Efficacy analysis set, consist of all Fistulizing Active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | 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 | Clinical response at 6 months | 2 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 30 months | 2 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 18 months | 4 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 36 months | 1 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 42 months | 0 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 12 months | 3 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 48 months | 0 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 24 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 48 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 6 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 12 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 18 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 24 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 30 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 42 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 36 months | 0 Participants |
Secondary
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.
Time frame: Every 6 months (months 6 -42)
Population: Efficacy analysis set, consist of all Pediatric severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each timepoint and baseline.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | 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 | Clinical response at 30 months | 0 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 6 months | 15 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 12 months | 18 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 18 months | 17 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 24 months | 10 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 36 months | 2 Participants |
| Remsima (CT-P13) | 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 | Clinical response at 42 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 36 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 24 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 6 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 30 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 12 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 42 months | 1 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response at 18 months | 0 Participants |
Secondary
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.
Time frame: Every 6 months (months 6 - 18)
Population: Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | Clinical response at 6 months | 1 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | Clinical response at 12 months | 1 Participants |
| Remsima (CT-P13) | Number and Percentage of Patients Achieving Clinical Response, Decrease From Baseline in the Paediatric Ulcerative Colitis Activity Index (PUCAI) ≥20 Score | Clinical response at 18 months | 1 Participants |
Secondary
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.
Time frame: Every 6 months (months 6 -60)
Population: Efficacy analysis set, consist of all moderate-severe active Crohn's Disease patients who received at least one dose of the study treatment during any dosing period and had at least one efficacy result corresponding to indication used for analysis after treatment. The denominators of proportions are the number of patients with non-missing efficacy result at each time point and baseline. Some rows have 0 participants analyzed because there were no patients applicable for analysis on this visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 60 months | 2 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 18 months | 39 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 24 months | 27 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 30 months | 24 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 36 months | 22 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 42 months | 13 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 54 months | 12 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 48 months | 8 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 60 months | 2 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 6 months | 33 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 12 months | 36 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 18 months | 34 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 24 months | 24 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 30 months | 24 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 36 months | 18 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 42 months | 12 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 48 months | 12 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 54 months | 8 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 6 months | 36 Participants |
| Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 12 months | 42 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 6 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 30 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 12 months | 4 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 6 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 18 months | 3 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 54 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 24 months | 4 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 12 months | 3 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 30 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 36 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 36 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 18 months | 3 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 42 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 48 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 54 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 24 months | 2 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-70 at 48 months | 0 Participants |
| Switched to Remsima (CT-P13) | 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 | Clinical response according to CDAI-100 at 42 months | 0 Participants |