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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004121-13 | EudraCT Number |
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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 If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 80 mg | Experimental | All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Adalimumab pre-filled syringe, administered by subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morio Ozawa, MS | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30221150 | Derived | Motoya S, Watanabe M, Wallace K, Lazar A, Nishimura Y, Ozawa M, Thakkar R, Robinson AM, Singh RSP, Mostafa NM, Suzuki Y, Hibi T. Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn's Disease Who Lost Response to Maintenance Therapy. Inflamm Intest Dis. 2018 Jul;2(4):228-235. doi: 10.1159/000486786. Epub 2018 May 15. |
| Label | URL |
|---|---|
| Related Info. | View source |
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This study included a 21-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
AEs were collected from the time of study drug administration until 70 days after last dose of study drug (60 weeks); SAEs were also collected from the time that informed consent was obtained until 70 days after last dose of study drug (up to 63 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 60 weeks |
| Baseline (Week 0) to Week 52 |
| 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. | Baseline (Week 0) to Week 52 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | FAS | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | FAS | Posted | Mean | Standard Deviation | mg/dL | Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | All participants in the FAS with available data at both time points. | Posted | Mean | Standard Deviation | µg/mL | Baseline (Week 0) to Week 52 |
|
|
|
| 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. | FAS | Posted | Number | participants | Baseline (Week 0) to Week 52 |
|
|
|
| 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. | Safety Analysis Set: All enrolled participants who received at least one dose of study drug. | Posted | Number | participants | 52 weeks |
|
|
|
| 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. | Safety Analysis Set | Posted | Number | participants | 52 weeks |
|
|
|
| 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. | Safety Analysis Set | Posted | Mean | Standard Deviation | mm Hg | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | Safety Analysis Set | Posted | Mean | Standard Deviation | mm Hg | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | Safety Analysis Set | Posted | Mean | Standard Deviation | bpm | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| Secondary | Body Temperature: Mean Change From Baseline (Week 0) to Each Visit | n=the number of participants with available data at each time point. | Safety Analysis Set | Posted | Mean | Standard Deviation | degrees Celcius | Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
|
|
|
| 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. | Safety Analysis Set | Posted | Number | participants | 60 weeks |
|
|
|
| 8 |
| 28 |
| 21 |
| 28 |
| ILEUS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| SMALL INTESTINAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| SEASONAL ALLERGY | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| MYCOPLASMA INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| OTITIS EXTERNA | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| PERIODONTITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| POSTOPERATIVE ABSCESS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| PULPITIS DENTAL | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| TEMPOROMANDIBULAR JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| RADICULOPATHY | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| FEMALE GENITAL TRACT FISTULA | Reproductive system and breast disorders | MedDRA (17.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 28 |
|
| Week 32 |
|
| Week 36 |
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| Week 40 |
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| Week 44 |
|
| Week 48 |
|
| Week 52 |
|
| Title | Measurements |
|---|---|
|
| Week 20 |
|
| Week 24 |
|
| Week 28 |
|
| Week 32 |
|
| Week 36 |
|
| Week 40 |
|
| Week 44 |
|
| Week 48 |
|
| Week 52 |
|
| Title | Measurements |
|---|---|
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 28 |
|
| Week 32 |
|
| Week 36 |
|
| Week 40 |
|
| Week 44 |
|
| Week 48 |
|
| Week 52 |
|
| Title | Measurements |
|---|---|
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 28 |
|
| Week 32 |
|
| Week 36 |
|
| Week 40 |
|
| Week 44 |
|
| Week 48 |
|
| Week 52 |
|
| Title | Measurements |
|---|---|
|
| Week 16 |
|
| Week 20 |
|
| Week 24 |
|
| Week 28 |
|
| Week 32 |
|
| Week 36 |
|
| Week 40 |
|
| Week 44 |
|
| Week 48 |
|
| Week 52 |
|
| Title | Measurements |
|---|---|
|
| White Blood Cells <2.0x10^3/mcL (n=28) |
|
| Neutrophils <1.0x10^3/mcL(n=28) |
|
| Lymphocytes <0.5x10^3/mcL (n=28) |
|
| Title | Measurements |
|---|---|
|
| Alkaline Phosphatase >5xU/L (n=28) |
|
| Total Bilirubin >3xULN (n=28) |
|
| Creatine Phosphokinase >5x ULN (n=28) |
|
| Creatinine >3xULN or >3xBL (n=28) |
|
| Uric Acid >10.0 mg/dL (n=28) |
|
| Inorganic Phosphate <2.0 mg/dL (n=28) |
|
| Calcium <7.0 mg/dL (n=28) |
|
| Calcium >12.5 mg/dL (n=28) |
|
| Sodium <130 mEq/L (n=28) |
|
| Sodium >155 mEq/L (n=28) |
|
| Potassium <3.0 mEq/L (n=27) |
|
| Potassium >6.0 mEq/L (n=28) |
|
| Non-fasting Glucose <40 mg/dL (n=28) |
|
| Non-fasting Glucose >250 mg/dL (n=28) |
|
| Albumin <2.0 g/dL (n=28) |
|
| Cholesterol >400 mg/dL(n=28) |
|
| Triglycerides >500 mg/dL(n=28) |
|
| Magnesium <0.9 mg/dL (n=28) |
|
| Magnesium >3.0 mg/dL (n=28) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=21) |
|
| Week 16 (n=21) |
|
| Week 20 (n=20) |
|
| Week 24 (n=20) |
|
| Week 28 (n=20) |
|
| Week 32 (n=20) |
|
| Week 36 (n=20) |
|
| Week 40 (n=20) |
|
| Week 44 (n=19) |
|
| Week 48 (n=19) |
|
| Week 52 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=21) |
|
| Week 16 (n=21) |
|
| Week 20 (n=20) |
|
| Week 24 (n=20) |
|
| Week 28 (n=20) |
|
| Week 32 (n=20) |
|
| Week 36 (n=20) |
|
| Week 40 (n=20) |
|
| Week 44 (n=19) |
|
| Week 48 (n=19) |
|
| Week 52 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=21) |
|
| Week 16 (n=21) |
|
| Week 20 (n=20) |
|
| Week 24 (n=20) |
|
| Week 28 (n=20) |
|
| Week 32 (n=20) |
|
| Week 36 (n=20) |
|
| Week 40 (n=20) |
|
| Week 44 (n=19) |
|
| Week 48 (n=19) |
|
| Week 52 (n=18) |
|
| Title | Measurements |
|---|---|
|
| Week 12 (n=21) |
|
| Week 16 (n=21) |
|
| Week 20 (n=20) |
|
| Week 24 (n=20) |
|
| Week 28 (n=20) |
|
| Week 32 (n=20) |
|
| Week 36 (n=20) |
|
| Week 40 (n=20) |
|
| Week 44 (n=19) |
|
| Week 48 (n=19) |
|
| Week 52 (n=18) |
|
| Title | Measurements |
|---|---|
|
| TESAE |
|
| Any TEAE Leading to Discontinuation of Study |
|
| Death |
|