Crohn's Disease
Conditions
Keywords
Dose Escalation, Crohn's Disease
Brief summary
The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
Detailed description
Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (≤ 21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone.
Interventions
BIOLOGICALAdalimumab
Adalimumab pre-filled syringe, administered by subcutaneous injection.
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject ≥ 15 years of age at the time of informed consent. * Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®. * Subject with elevated C-reactive Protein (CRP) at Screening. * If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug. * Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.
Exclusion criteria
* Subject with suspicion of colitis other than Crohn's disease. * Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded). * Subject with abscess or suspicion of abscess, or subject with infection(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 | Week 8 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure. |
| Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. |
| Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. |
| C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data. |
| Number of Participants With Potentially Significant Hematology Parameters | 52 weeks | Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value. |
| Number of Participants With Potentially Significant Clinical Chemistry Parameters | 52 weeks | Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter. |
| Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point. |
| Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point. |
| Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point. |
| Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | n=the number of participants with available data at each time point. |
| Number of Participants With Adverse Events (AEs) | 60 weeks | An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52 | Baseline (Week 0) to Week 52 | Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point. |
| Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52 | Baseline (Week 0) to Week 52 | Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose. |
Participant flow
Pre-assignment details
This study included a 21-day screening period.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab 80 mg All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Concomitant Prohibited Medicine for AE | 1 |
| Overall Study | Lack of Efficacy | 6 |
Baseline characteristics
| Characteristic | Adalimumab 80 mg |
|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 10.09 |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 21 / 28 |
| serious Total, serious adverse events | 8 / 28 |
Outcome results
Primary
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Week 8
Population: Full Analysis Set (FAS): All enrolled participants who received at least one dose of study drug and had at least one post-treatment efficacy assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8 | 75 percentage of participants |
Secondary
Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
n=the number of participants with available data at each time point.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 2 (n=28) | -0.03 degrees Celcius | Standard Deviation 0.558 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 4 (n=28) | -0.02 degrees Celcius | Standard Deviation 0.571 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 8 (n=25) | -0.08 degrees Celcius | Standard Deviation 0.569 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 12 (n=21) | -0.14 degrees Celcius | Standard Deviation 0.606 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 16 (n=21) | -0.11 degrees Celcius | Standard Deviation 0.558 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 20 (n=20) | -0.16 degrees Celcius | Standard Deviation 0.545 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 24 (n=20) | -0.20 degrees Celcius | Standard Deviation 0.701 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 28 (n=20) | -0.23 degrees Celcius | Standard Deviation 0.716 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 32 (n=20) | -0.26 degrees Celcius | Standard Deviation 0.762 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 36 (n=20) | -0.36 degrees Celcius | Standard Deviation 0.476 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 40 (n=20) | -0.16 degrees Celcius | Standard Deviation 0.555 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 44 (n=19) | -0.24 degrees Celcius | Standard Deviation 0.472 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 48 (n=19) | -0.03 degrees Celcius | Standard Deviation 0.781 |
| Adalimumab 80 mg | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | Week 52 (n=18) | -0.13 degrees Celcius | Standard Deviation 0.717 |
Secondary
C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy human serum is usually lower than 0.3 mg/dL, slightly increasing with age. Last Observation Carried Forward (LOCF) was used for missing data.
Time frame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 52 | -0.570 mg/dL | Standard Deviation 2.7635 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 4 | -0.570 mg/dL | Standard Deviation 1.4902 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 8 | -0.426 mg/dL | Standard Deviation 1.6072 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 12 | -0.710 mg/dL | Standard Deviation 1.6769 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 16 | -0.923 mg/dL | Standard Deviation 1.6981 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 20 | -0.907 mg/dL | Standard Deviation 1.7532 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 24 | -0.813 mg/dL | Standard Deviation 1.7924 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 28 | -0.833 mg/dL | Standard Deviation 1.882 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 32 | -0.853 mg/dL | Standard Deviation 2.0507 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 36 | -0.586 mg/dL | Standard Deviation 2.3271 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 40 | -1.008 mg/dL | Standard Deviation 2.0471 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 44 | -0.915 mg/dL | Standard Deviation 2.2324 |
| Adalimumab 80 mg | C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52 | Week 48 | -0.649 mg/dL | Standard Deviation 2.5734 |
Secondary
Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 2 (n=28) | -0.6 mm Hg | Standard Deviation 9.53 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 4 (n=28) | 0.2 mm Hg | Standard Deviation 8.56 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 8 (n=25) | 0.7 mm Hg | Standard Deviation 8.13 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 12 (n=21) | 1.1 mm Hg | Standard Deviation 7.12 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 16 (n=21) | 0.1 mm Hg | Standard Deviation 7.78 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 20 (n=20) | 0.8 mm Hg | Standard Deviation 9.38 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 24 (n=20) | 0.8 mm Hg | Standard Deviation 8.72 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 28 (n=20) | -0.5 mm Hg | Standard Deviation 7.81 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 32 (n=20) | -0.8 mm Hg | Standard Deviation 9.27 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 36 (n=20) | -0.4 mm Hg | Standard Deviation 10.27 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 40 (n=20) | 0.7 mm Hg | Standard Deviation 10.66 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 44 (n=19) | -1.2 mm Hg | Standard Deviation 8.57 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 48 (n=19) | 1.3 mm Hg | Standard Deviation 8.48 |
| Adalimumab 80 mg | Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 52 (n=18) | 3.0 mm Hg | Standard Deviation 11.97 |
Secondary
Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
Heart rate was measured while the participant was sitting. n=the number of participants with available data at each time point.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 2 (n=28) | -0.3 bpm | Standard Deviation 11.94 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 4 (n=28) | 0.7 bpm | Standard Deviation 12.78 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 8 (n=25) | -1.1 bpm | Standard Deviation 9.48 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 12 (n=21) | -1.1 bpm | Standard Deviation 11.59 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 16 (n=21) | -1.9 bpm | Standard Deviation 9.56 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 20 (n=20) | -3.0 bpm | Standard Deviation 8.68 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 24 (n=20) | -0.9 bpm | Standard Deviation 13.15 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 28 (n=20) | -1.6 bpm | Standard Deviation 11.3 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 32 (n=20) | -5.6 bpm | Standard Deviation 11.95 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 36 (n=20) | -4.7 bpm | Standard Deviation 12.88 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 40 (n=20) | -3.7 bpm | Standard Deviation 13.88 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 44 (n=19) | -2.0 bpm | Standard Deviation 10.78 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 48 (n=19) | -1.3 bpm | Standard Deviation 15.53 |
| Adalimumab 80 mg | Heart Rate: Mean Change From Baseline (Week 0) to Each Visit | Week 52 (n=18) | -2.8 bpm | Standard Deviation 11.8 |
Secondary
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either Reasonable possibility or No reasonable possibility of being related to study drug. For more details on adverse events please see the AE section below.
Time frame: 60 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | Any TEAE | 24 participants |
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | TEAEs with reasonable possibility of being related | 5 participants |
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | Any severe TEAE | 2 participants |
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | TESAE | 8 participants |
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | Any TEAE Leading to Discontinuation of Study | 4 participants |
| Adalimumab 80 mg | Number of Participants With Adverse Events (AEs) | Death | 0 participants |
Secondary
Number of Participants With Potentially Significant Clinical Chemistry Parameters
Blood was collected for analysis at designated study visits; chemistry results were provided by a central laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value for each parameter.
Time frame: 52 weeks
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Alanine Aminotransferase >5xULN (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Aspartate Aminotransferase >5xULN (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Gamma-glutamyl Transpeptidase >5x ULN (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Alkaline Phosphatase >5xU/L (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Total Bilirubin >3xULN (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Creatine Phosphokinase >5x ULN (n=28) | 1 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Creatinine >3xULN or >3xBL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Uric Acid >10.0 mg/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Inorganic Phosphate <2.0 mg/dL (n=28) | 3 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Calcium <7.0 mg/dL (n=28) | 1 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Calcium >12.5 mg/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Sodium <130 mEq/L (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Sodium >155 mEq/L (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Potassium <3.0 mEq/L (n=27) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Potassium >6.0 mEq/L (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Non-fasting Glucose <40 mg/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Non-fasting Glucose >250 mg/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Albumin <2.0 g/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Cholesterol >400 mg/dL(n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Triglycerides >500 mg/dL(n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Magnesium <0.9 mg/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Clinical Chemistry Parameters | Magnesium >3.0 mg/dL (n=28) | 0 participants |
Secondary
Number of Participants With Potentially Significant Hematology Parameters
Blood was collected for analysis at designated study visits; hematology results were provided by each site laboratory. The number of participants with an abnormal laboratory result (higher than upper limit of normal \[ULN\] or lower than lower limit of normal \[LLN\]) meeting Common Toxicity Criteria (CTC) of Grade 3 or higher is summarized. Increase is signified by ↑. n=the number of participants with CTC Grade \<3 at baseline and a post-baseline value.
Time frame: 52 weeks
Population: Safety Analysis Set: All enrolled participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | Haemoglobin <8 g/dL (n=27) | 1 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | Haemoglobin ↑ >4.0 g/dL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | Platelet Count <5.0x10^4/mcL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | White Blood Cells <2.0x10^3/mcL (n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | Neutrophils <1.0x10^3/mcL(n=28) | 0 participants |
| Adalimumab 80 mg | Number of Participants With Potentially Significant Hematology Parameters | Lymphocytes <0.5x10^3/mcL (n=28) | 4 participants |
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 4 | 14.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 8 | 25.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 12 | 28.6 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 16 | 32.1 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 20 | 35.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 24 | 42.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 28 | 35.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 32 | 42.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 36 | 39.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 40 | 39.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 44 | 42.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 48 | 39.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52 | Week 52 | 35.7 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 4 | 32.1 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 8 | 35.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 12 | 39.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 16 | 46.4 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 20 | 50.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 24 | 50.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 28 | 42.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 32 | 50.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 36 | 50.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 40 | 57.1 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 44 | 46.4 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 48 | 50.0 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52 | Week 52 | 46.4 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used. Week 8 was the primary outcome measure.
Time frame: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 4 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 12 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 16 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 20 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 24 | 71.4 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 28 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 32 | 71.4 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 36 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 40 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 44 | 60.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 48 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52 | Week 52 | 57.1 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 4 | 46.4 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 8 | 57.1 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 12 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 16 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 20 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 24 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 28 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 32 | 67.9 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 36 | 64.3 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 40 | 60.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 44 | 57.1 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 48 | 60.7 percentage of participants |
| Adalimumab 80 mg | Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52 | Week 52 | 57.1 percentage of participants |
Secondary
Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
Blood pressure was measured while the participant was sitting. n=the number of participants with available data at each time point.
Time frame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Population: Safety Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 2 (n=28) | -3.9 mm Hg | Standard Deviation 11.98 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 4 (n=28) | -2.5 mm Hg | Standard Deviation 9.41 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 8 (n=25) | -1.1 mm Hg | Standard Deviation 9.98 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 12 (n=21) | -1.3 mm Hg | Standard Deviation 9.34 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 16 (n=21) | -0.2 mm Hg | Standard Deviation 11.72 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 20 (n=20) | 1.9 mm Hg | Standard Deviation 12.64 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 24 (n=20) | 2.0 mm Hg | Standard Deviation 8.89 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 28 (n=20) | 0.8 mm Hg | Standard Deviation 8.91 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 32 (n=20) | -1.7 mm Hg | Standard Deviation 7.41 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 36 (n=20) | -0.5 mm Hg | Standard Deviation 10.79 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 40 (n=20) | 2.3 mm Hg | Standard Deviation 9.55 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 44 (n=19) | 1.9 mm Hg | Standard Deviation 14.12 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 48 (n=19) | 4.6 mm Hg | Standard Deviation 11.66 |
| Adalimumab 80 mg | Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit | Week 52 (n=18) | -0.3 mm Hg | Standard Deviation 9.41 |
Other Pre-specified
Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated heterogeneous electrochemiluminescence (ECL)-immunoassay method. The assay captures adalimumab via biotinylated anti-idiotypic antibody, and detects it via sulfo-tagged TNF-alpha. n=the number of participants with available data at each time point.
Time frame: Baseline (Week 0) to Week 52
Population: All participants in the FAS with available data at both time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab 80 mg | Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52 | Baseline (Week 0) (n=28) | 3.06 µg/mL | Standard Deviation 2.19 |
| Adalimumab 80 mg | Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52 | Week 52 (n=18) | 9.47 µg/mL | Standard Deviation 5.34 |
Other Pre-specified
Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
Serum samples with adalimumab concentration below 2 μg/mL were selected for AAA analyses. Samples were considered AAA positive if the measured AAA concentration was above 20 ng/mL. A subject was considered to be AAA positive if the subject had at least one AAA positive sample observed within 30 days following the subject's last adalimumab dose.
Time frame: Baseline (Week 0) to Week 52
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab 80 mg | Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52 | Baseline (Week 0) | 3 participants |
| Adalimumab 80 mg | Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52 | Week 52 | 4 participants |