Crohn's Disease
Conditions
Keywords
Certolizumab Pegol, Cimzia ®, Crohn's Disease
Brief summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.
Interventions
DRUGCertolizumab Pegol
400 mg administered subcutaneously at once every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg \*prior to this dosing regimen, subjects will undergo an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg
Sponsors
UCB Celltech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with active Crohn's Disease (CD) confirmed 3 months prior to Screening * Subjects with a Pediatric Crohn's Disease Activity Index (PCDAI) score of \> 30 at Week 0 * Subjects between the ages of 6 and 17, inclusive, prior to baseline dosing * Subjects must weigh \> 20 kg (44 lbs) * Subjects must have normal Electrocardiogram (ECG) or no medically relevant abnormalities as assessed by the investigator * Subjects must meet Tuberculosis (TB) screening criteria * Subjects taking corticosteroids, antibiotics and analgesics must have stable dosing, as defined, for one week
Exclusion criteria
* Subjects who score \> 5 on the perirectal disease item of the PCDAI at Baseline * Subjects who have had an active enterocutaneous fistulae within 3 months prior to Baseline * Subjects with non-enterocutaneous fistulae, signs or symptoms of bowel obstruction or short bowel syndrome * Subjects with a functional colostomy or ileostomy * Subjects who have had surgical bowel resection within 6 months prior to Baseline or who may be planning any resection while enrolled in the study * Subjects with clinical suspicion of intraabdominal abscesses * Subjects with a positive stool result for enteric pathogens and/or parasites * Subject has received any investigational biological therapies (within or outside a clinical trial) within 12 weeks prior to Screening or has been dosed in any clinical trial using non biological therapies within 4 weeks prior to Screening * Subjects who have lost response to another Tumor Necrosis Factor (TNF) agent * Subjects may not use another TNF agent within 12 weeks of Screening Visit * Subjects with any prior exposure to natalizumab * Subjects who have received mycophenolate or thalidomide within 4 weeks prior to Screening * Subjects who have received cyclosporin or tacrolimus within 6 months prior to Screening * Subjects who have received parenteral corticosteroids within 2 weeks prior to Screening * Subjects who have received corticosteroids or corticotrophins for indications other than CD within 2 weeks of Screening * Subject has a current or recent history (within 6 months prior to Screening) of significant and severe renal, hepatic, hematological, gastrointestinal (other than CD), endocrine, pulmonary, cardiac, neurological, or cerebral disease including blood dyscrasia (eg, pancytopenia, aplastic anemia), demyelinating disease (eg, multiple sclerosis, myelitis, optic neuritis), or ischemic heart disease * Subjects with a current sign or symptom indicating recent or chronic infections (including herpes zoster) * Subject has negative test for Immunoglobulin G (IgG) against Varicella zoster (chicken pox) * Subjects who have not completed their primary vaccination series, or are planning to have a live vaccine administered during the study period or up to 3 months after last dose of study drug * Subject has a history of TB or a positive chest x-ray suggestive of TB * Subjects with known concurrent viral hepatitis or Acquired Immune Deficiency Syndrome (AIDS) or known Human Immunodeficiency Virus (HIV) infection * Subjects with concurrent malignancy or history of malignancy, excluding treated squamous cell carcinoma of the skin * Subject has concurrent bowel dysplasia or a history of bowel dysplasia in the 5 years prior to Screening * Subjects with a history lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoma at any time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects in Clinical Remission at Week 62 | Week 62 | Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) | From Week 0 to Week 62 | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. A negative value in change from Baseline indicates an improvement from Baseline to Week 62. |
| Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) | From Week 0 to Week 62 | Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. |
| C-Reactive Protein (CRP) Levels at Week 62 | Week 62 | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD) |
| Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) | From Week 0 to Week 62 | The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator. |
| Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 | Week 62 | The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. |
| Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) | From Week 0 to Week 62 | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator. |
| Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | From Week 0 to Week 62 | The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development. |
| Percentage of Subjects Who Initiated Steroid Tapering | From Week 2 up to Week 8 | Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose. |
| Percentage of Subjects in Corticosteroid-free Remission at the End of the Study | Last/Withdrawal Visit (up to Week 62) | Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available. |
| Erythrocyte Sedimentation Rate (ESR) at Week 62 | Week 62 | The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). |
Countries
Australia, Canada, New Zealand, United States
Participant flow
Recruitment details
The Participant Flow refers to the Safety Set (SS) population. The Safety Population includes all subjects enrolled who received at least 1 injection of study treatment.
Pre-assignment details
During an Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W). Subjects who showed a clinical response at Week 6 were randomized in a 1:1 ratio to one of 2 dose groups. Subjects who did not respond at Week 6 were withdrawn from the study.
Participants by arm
| Arm | Count |
|---|---|
| Induction Only Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:
* 400 mg for subjects ≥ 40 kg
* 200 mg for subjects 20 to \< 40 kg | 27 |
| Maintenance Low-Dose Maintenance Low-Dose group\*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg | 37 |
| Maintenance High-Dose Maintenance High-Dose group\*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to \< 40 kg
\*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg | 35 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Induction Period (Weeks 0 to 6) | Adverse Event | 6 | 0 | 0 |
| Induction Period (Weeks 0 to 6) | Lack of Efficacy | 17 | 0 | 0 |
| Induction Period (Weeks 0 to 6) | Other reason | 1 | 0 | 0 |
| Induction Period (Weeks 0 to 6) | Protocol Violation | 1 | 0 | 0 |
| Maintenance Period (Weeks 8 to 62) | Adverse Event | 0 | 10 | 5 |
| Maintenance Period (Weeks 8 to 62) | Lack of Efficacy | 0 | 11 | 18 |
| Maintenance Period (Weeks 8 to 62) | Other reason | 0 | 2 | 2 |
| Maintenance Period (Weeks 8 to 62) | Protocol Violation | 0 | 1 | 1 |
| Maintenance Period (Weeks 8 to 62) | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Induction Only | Maintenance Low-Dose | Maintenance High-Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 13.8 years STANDARD_DEVIATION 2.67 | 13.2 years STANDARD_DEVIATION 2.41 | 13.4 years STANDARD_DEVIATION 2.46 | 13.4 years STANDARD_DEVIATION 2.48 |
| Age, Customized 12-17 years | 21 participants | 28 participants | 27 participants | 76 participants |
| Age, Customized 6-11 years | 6 participants | 9 participants | 8 participants | 23 participants |
| Body Mass Index (BMI) | 18.39 kilogram per square meter STANDARD_DEVIATION 2.504 | 18.51 kilogram per square meter STANDARD_DEVIATION 3.531 | 19.79 kilogram per square meter STANDARD_DEVIATION 4.897 | 18.93 kilogram per square meter STANDARD_DEVIATION 3.869 |
| Body Surface Area (BSA) | 1.42 square meter STANDARD_DEVIATION 0.25 | 1.39 square meter STANDARD_DEVIATION 0.272 | 1.47 square meter STANDARD_DEVIATION 0.319 | 1.43 square meter STANDARD_DEVIATION 0.283 |
| Height | 157.46 centimeter STANDARD_DEVIATION 13.841 | 155.32 centimeter STANDARD_DEVIATION 13.589 | 157.22 centimeter STANDARD_DEVIATION 13.32 | 156.57 centimeter STANDARD_DEVIATION 13.46 |
| Race/Ethnicity, Customized American Indian / Alaskan Native | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Black | 3 participants | 3 participants | 8 participants | 14 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other / Mixed | 1 participants | 2 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized White | 22 participants | 32 participants | 27 participants | 81 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 17 Participants | 27 Participants | 14 Participants | 58 Participants |
| Weight | 46.50 kilogram STANDARD_DEVIATION 12.565 | 45.67 kilogram STANDARD_DEVIATION 14.638 | 50.35 kilogram STANDARD_DEVIATION 18.569 | 47.55 kilogram STANDARD_DEVIATION 15.642 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 99 | 28 / 37 | 27 / 35 | 78 / 99 |
| serious Total, serious adverse events | 6 / 99 | 4 / 37 | 4 / 35 | 14 / 99 |
Outcome results
Primary
Percentage of Subjects in Clinical Remission at Week 62
Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Time frame: Week 62
Population: Full Analysis Set (FAS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Low-Dose | Percentage of Subjects in Clinical Remission at Week 62 | 24.3 percentage of participants |
| Maintenance High-Dose | Percentage of Subjects in Clinical Remission at Week 62 | 17.1 percentage of participants |
Secondary
Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62
The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Time frame: Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High-Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Low-Dose | Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 | 8.18 Score on a scale | Standard Deviation 6.9 |
| Maintenance High-Dose | Absolute Pediatric Crohn's Disease Activity Index (PCDAI) Scores at Week 62 | 7.14 Score on a scale | Standard Deviation 7.83 |
Secondary
Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62)
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at Baseline as the denominator.
Time frame: From Week 0 to Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Maintenance Low-Dose | Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) | 0.49 ratio |
| Maintenance High-Dose | Change in C-Reactive Protein (CRP) Levels From Week 0 to the End of the Study (Week 62) | 1.84 ratio |
Secondary
Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62)
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD). Changes from Baseline in CRP levels are expressed as a ratio with the value measured at baseline as the denominator.
Time frame: From Week 0 to Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Maintenance Low-Dose | Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) | 0.57 ratio |
| Maintenance High-Dose | Change in Erythrocyte Sedimentation Rate (ESR) From Week 0 to the End of the Study (Week 62) | 1.08 ratio |
Secondary
Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62)
The Tanner stage is an assessment of developmental stage on external genitalia and pubic hair (boys), and on breast and pubic hair (girls). Values range from 1 to 5 where a higher number indicates more development.
Time frame: From Week 0 to Week 62
Population: Full Analysis Analysis (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 10 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Growth scores.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage I to Stage II | 2 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage I to Stage III | 1 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage II to Stage III | 0 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage III to Stage IV | 2 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage IV to Stage V | 0 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Decrease from Stage IV to Stage III | 1 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage I | 0 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage III | 0 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage IV | 1 participants |
| Maintenance Low-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage V | 3 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage III | 2 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage I to Stage II | 0 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Decrease from Stage IV to Stage III | 1 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage I to Stage III | 1 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage V | 0 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage II to Stage III | 1 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage I | 1 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage III to Stage IV | 0 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Subjects remained in Stage IV | 0 participants |
| Maintenance High-Dose | Change in Growth Scores (Tanner Stage [Assessing Puberty]) From Week 0 to the End of the Study (Week 62) | Increase from Stage IV to Stage V | 1 participants |
Secondary
Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62)
The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity. A negative value in change from Baseline indicates an improvement from Baseline to Week 62.
Time frame: From Week 0 to Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid Pediatric Crohn's Disease Activity Index (PCDAI) scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Maintenance Low-Dose | Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) | -29.77 units on a scale | Standard Deviation 8.097 |
| Maintenance High-Dose | Change in Pediatric Crohn's Disease Activity Index (PCDAI) Scores From Week 0 to the End of the Study (Week 62) | -27.14 units on a scale | Standard Deviation 5.669 |
Secondary
C-Reactive Protein (CRP) Levels at Week 62
The C-Reactive Protein (CRP) is a considered marker of inflammation in subjects with Crohn's Disease (CD)
Time frame: Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 11 subjects in the Low-Dose group and 7 subjects in the High-Dose group with valid C-Reactive Protein (CRP) levels.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Maintenance Low-Dose | C-Reactive Protein (CRP) Levels at Week 62 | 7.2 mg/L |
| Maintenance High-Dose | C-Reactive Protein (CRP) Levels at Week 62 | 5.8 mg/L |
Secondary
Erythrocyte Sedimentation Rate (ESR) at Week 62
The Erythrocyte Sedimentation Rate (ESR) is a considered biomarker of inflammation in subjects with Crohn's Disease (CD).
Time frame: Week 62
Population: Full Analysis Set (FAS) population. At the start of the Maintenance Period, the FAS had 37 subjects in the Low-Dose group and 35 subjects in the High- Dose group. However, at Week 62, there were only 12 subjects in the Low-Dose group and 7 subjects in the High-Dose group with a valid Erythrocyte Sedimentation Rate (ESR).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Maintenance Low-Dose | Erythrocyte Sedimentation Rate (ESR) at Week 62 | 20.9 mm/h |
| Maintenance High-Dose | Erythrocyte Sedimentation Rate (ESR) at Week 62 | 25.2 mm/h |
Secondary
Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62)
Clinical response is defined as a decrease from Week 0 in Pediatric Crohn's Disease Activity Index (PCDAI) score of ≥ 15 points and a total PCDAI score ≤ 30 points. The Pediatric Crohn's Disease Activity Index (PCDAI) consists of 4 domains (laboratory, height/weight, examination, and history) with several assessments that are converted into a PCDAI score which can range from 0 to 100 points, with a higher score indicating more severe disease activity.
Time frame: From Week 0 to Week 62
Population: Full Analysis Set (FAS) population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Low-Dose | Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) | 29.7 percentage of participants |
| Maintenance High-Dose | Percentage of Subjects Achieving Clinical Response From Week 0 to the End of the Study (Week 62) | 20.0 percentage of participants |
Secondary
Percentage of Subjects in Corticosteroid-free Remission at the End of the Study
Corticosteroid use at end of study is defined as 84 days past the last dose of study medication. Remission is assessed at the last visit where Pediatric Crohn's Disease Activity index (PCDAI) data is available.
Time frame: Last/Withdrawal Visit (up to Week 62)
Population: Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Low-Dose | Percentage of Subjects in Corticosteroid-free Remission at the End of the Study | 23.8 percentage of paticipants |
| Maintenance High-Dose | Percentage of Subjects in Corticosteroid-free Remission at the End of the Study | 15.0 percentage of paticipants |
Secondary
Percentage of Subjects Who Initiated Steroid Tapering
Subjects receiving corticosteroids at Screening may start a defined tapering schedule between Weeks 2 and 8. Corticosteroid tapering must start at the latest by Week 8. Corticosteroid doses are tapered at different rates depending on the subject's dose.
Time frame: From Week 2 up to Week 8
Population: Full Analysis Set (FAS) population. There were only 21 subjects in the Low-Dose group and 20 subjects in the High-Dose group who took steroids during the Maintenance Period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Maintenance Low-Dose | Percentage of Subjects Who Initiated Steroid Tapering | 71.4 percentage of subjects |
| Maintenance High-Dose | Percentage of Subjects Who Initiated Steroid Tapering | 65.0 percentage of subjects |