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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017938-46 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind Placebo EOW | Placebo Comparator | Placebo for adalimumab every other week (eow) for 12 weeks. |
|
| Double-blind Adalimumab EOW | Experimental | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks. |
|
| Open-label Adalimumab EOW | Experimental | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Adalimumab solution for subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sites of Enthesitis: Change From Baseline to Week 12 | The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaclyn Anderson, DO, MS | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26223543 | Result | Burgos-Vargas R, Tse SM, Horneff G, Pangan AL, Kalabic J, Goss S, Unnebrink K, Anderson JK. A Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis-Related Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1503-12. doi: 10.1002/acr.22657. | |
| 30054164 | Derived |
| Label | URL |
|---|---|
| Related Info. | View source |
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The study included a 30-day screening period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo EOW | Placebo for adalimumab every other week (eow) for 12 weeks. |
| FG001 | Double-blind Adalimumab EOW | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks. |
| FG002 | Open-label Adalimumab EOW | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Double-blind Period |
| |||||||||||||
| Open-label Period |
|
Intent-to-treat (ITT) population: All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind Placebo EOW | Placebo for adalimumab every other week (eow) for 12 weeks. |
| BG001 | Double-blind Adalimumab EOW | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks. |
| 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 | Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12 | A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data. | ITT population | Posted | Mean | Standard Deviation | percent change | Baseline and Week 12 |
|
Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind [DB] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
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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 | Double-blind Placebo EOW | Placebo for adalimumab every other week (eow) for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INCREASED TENDENCY TO BRUISE | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D013167 | Spondylitis, Ankylosing |
| D058566 | Sacroiliitis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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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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| placebo for adalimumab | Biological | Placebo for adalimumab solution for subcutaneous injection. |
|
| Tender Joint Count (TJC72): Change From Baseline to Week 12 | Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | Baseline and Week 12 |
| Swollen Joint Count (SJC68): Change From Baseline to Week 12 | Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | Baseline and Week 12 |
| Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30) | The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data. | Baseline and Week 12 |
| Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50) | The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used. | Baseline and Week 12 |
| Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70) | The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used. | Baseline and Week 12 |
| 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 probably related to study drug, possibly related to study drug, probably not related, or not related to study drug. For more details on adverse events please see the AE section below. | Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks) |
| Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25. |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks. |
|
|
|
| Secondary | Number of Sites of Enthesitis: Change From Baseline to Week 12 | The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | ITT population | Posted | Mean | Standard Deviation | sites of enthesitis | Baseline and Week 12 |
|
|
|
|
| Secondary | Tender Joint Count (TJC72): Change From Baseline to Week 12 | Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
|
|
|
|
| Secondary | Swollen Joint Count (SJC68): Change From Baseline to Week 12 | Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used. | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30) | The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data. | ITT population | Posted | Number | percentage of participants | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50) | The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used. | ITT population | Posted | Number | percentage of participants | Baseline and Week 12 |
|
|
|
|
| Secondary | Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70) | The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with >30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used. | ITT population | Posted | Number | percentage of participants | Baseline and Week 12 |
|
|
|
|
| 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 probably related to study drug, possibly related to study drug, probably not related, or not related to study drug. For more details on adverse events please see the AE section below. | Safety population: All randomized subjects who received at least 1 dose of study drug | Posted | Number | participants | Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks) |
|
|
|
| 0 |
| 15 |
| 8 |
| 15 |
| EG001 | Double-blind Adalimumab EOW | Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks. | 1 | 31 | 21 | 31 |
| EG002 | Any Adalimumab | All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks. | 10 | 46 | 46 | 46 |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| DISSEMINATED TUBERCULOSIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| BURNS SECOND DEGREE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| BURNS THIRD DEGREE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| TUBERCULIN TEST POSITIVE | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| JOINT INSTABILITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| JUVENILE IDIOPATHIC ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| DIFFUSE VASCULITIS | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.0 | Systematic Assessment |
|
| ASTIGMATISM | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| CONJUNCTIVITIS ALLERGIC | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 18.0 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ANAL FISSURE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| TOOTHACHE | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ADVERSE DRUG REACTION | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| INFLAMMATION | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| INJECTION SITE PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| INJECTION SITE PRURITUS | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| INJECTION SITE URTICARIA | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| PERIPHERAL SWELLING | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| HEPATOCELLULAR INJURY | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| ALLERGY TO ARTHROPOD BITE | Immune system disorders | MedDRA 18.0 | Systematic Assessment |
|
| ABSCESS LIMB | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ACARODERMATITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ACUTE SINUSITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| CANDIDA INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| CONJUNCTIVITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| EAR INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| FUNGAL SKIN INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| LARYNGITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ORCHITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| OTITIS MEDIA CHRONIC | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PARONYCHIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PHARYNGOTONSILLITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PILONIDAL CYST | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ROTAVIRUS INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| SCARLET FEVER | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| TINEA INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| TINEA PEDIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| TONSILLITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| TONSILLITIS BACTERIAL | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| TRACHEITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| VARICELLA | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| VIRAL TONSILLITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| LACERATION | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| LIMB INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| LIP INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| POST-TRAUMATIC PAIN | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| SKELETAL INJURY | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| TOOTH FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| TRAUMATIC HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| TRAUMATIC HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| BLOOD PRESSURE INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| BONE DENSITY DECREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| WEIGHT INCREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| METABOLIC SYNDROME | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| GROWING PAINS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| JUVENILE IDIOPATHIC ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| OSTEOCHONDROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| ATTENTION DEFICIT/HYPERACTIVITY DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| TIC | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| BLADDER SPASM | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| IGA NEPHROPATHY | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| LEUKOCYTURIA | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| PENIS DISORDER | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| SCROTAL PAIN | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| VARICOCELE | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| ADENOIDAL HYPERTROPHY | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| TONSILLAR INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| VASOMOTOR RHINITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| KERATOSIS PILARIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| PITYRIASIS ROSEA | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| PUSTULAR PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SEBORRHOEIC DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SOLAR DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| PREHYPERTENSION | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| RAYNAUD'S PHENOMENON | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| VASCULITIS | Vascular disorders | MedDRA 18.0 | 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.
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Change from Baseline to Week 12 |
|
| Change from Baseline to Week 12 |
|
| Change from Baseline to Week 12 |
|
|
| Any severe TEAE |
|
| TESAE |
|
| Any TEAE Leading to Discontinuation of Study |
|
| Death |
|