The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.
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 If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study.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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Adalimumab pre-filled syringe, administered by subcutaneous injection.
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
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
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
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
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
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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
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
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
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
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
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
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
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
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