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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
This was an open-label long-term study that was completed following study drug approval in Japan for the treatment of JRA. Data are presented through Week 144 and for the final visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 | Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16 | Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Shigeki Hashimoto, PhD | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 47248 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 47253 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30054164 | Derived | 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. | |
| 23053683 |
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Adalimumab dose was determined by baseline body weight (20 mg for subjects weighing < 30 kg, 40 mg for subjects weighing 30 kg or more) through Week 14. After Week 16, dose was based on body weight measured at Week 16 and every 12 weeks. Twenty subjects received concomitant methotrexate therapy during the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Subjects Achieving Pediatric American College of Rheumatology 30% (PedACR30) Response at Week 16 | Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. | The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. | Posted | Number | Participants | Week 16 |
|
All adverse events reported from the time of first study drug administration until 70 days following discontinuation of study drug administration were collected.
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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 | Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
Not provided
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic 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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|
| Week 16 |
| Number of Subjects Achieving PedACR 30/50/70 Responses | Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit |
| Mean Serum Adalimumab Concentration | Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL). | Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60 |
| Number of Subjects Positive for Anti-adalimumab Antibodies (AAA) | Serum samples with adalimumab concentration below 2 mcg/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. | Week 24 and Week 60 |
| Fukuoka |
| Japan |
| Site Reference ID/Investigator# 47251 | Hyōgo | Japan |
| Site Reference ID/Investigator# 47254 | Kagoshima | Japan |
| Site Reference ID/Investigator# 47250 | Kobe | Japan |
| Site Reference ID/Investigator# 47255 | Okinawa | Japan |
| Site Reference ID/Investigator# 7153 | Sendai | Japan |
| Site Reference ID/Investigator# 47249 | Takatsuki | Japan |
| Site Reference ID/Investigator# 47243 | Tokyo | Japan |
| Site Reference ID/Investigator# 47244 | Tokyo | Japan |
| Site Reference ID/Investigator# 47245 | Tokyo | Japan |
| Site Reference ID/Investigator# 47246 | Yokohama | Japan |
| Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T, Iwata N, Murata T, Okafuji I, Miyoshi M, Onoe Y, Kawano Y, Kinjo N, Mori M, Mozaffarian N, Kupper H, Santra S, Patel G, Kawai S, Yokota S. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012 Dec;31(12):1713-21. doi: 10.1007/s10067-012-2082-5. Epub 2012 Oct 2. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).
|
|
| Secondary | Number of Subjects Achieving PedACR50 and PedACR70 Responses at Week 16 | Response defined as at least 50/70% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 50/70% worsening in not more than 1 JRA criterion compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. | The analysis was conducted using the full analysis set (FAS) population, which was defined as all subjects who received at least one dose of study drug. Missing values were treated as non-responders. | Posted | Number | Participants | Week 16 |
|
|
|
| Secondary | Number of Subjects Achieving PedACR 30/50/70 Responses | The analysis was conducted using the full analysis set (FAS) population (all subjects who received at least 1 dose of study drug) as observed. N=25 at Weeks 2, 4, and the Final Visit; N=24 at Weeks 8, 24, and 36; N=23 at Week 48; N=22 at Week 60; N=19 at Weeks 72 and 96; N=11 at Week 120; and N=5 at Week 144. | Posted | Number | Participants | Week 2, 4, 8, and 24, every 12 weeks from Week 24 to Week 60, and every 24 weeks from Week 72 to the final visit |
|
|
|
| Secondary | Mean Serum Adalimumab Concentration | Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method based on a double-antigen technique. Concentrations are reported as micrograms per milliliter (mcg/mL). | For the 20 mg dose, N = 8 at each timepoint. For the 40 mg dose, N = 17 at Weeks 2 and 4; N = 16 at Weeks 8, 16, and 24; N = 14 at Week 36; N = 15 at Week 48; and N = 14 at Week 60. | Posted | Mean | Standard Deviation | mcg/mL | Week 2, 4, 8, 16, and 24, and every 12 weeks up to Week 60 |
|
|
|
| Secondary | Number of Subjects Positive for Anti-adalimumab Antibodies (AAA) | Serum samples with adalimumab concentration below 2 mcg/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. | Posted | Number | Participants | Week 24 and Week 60 |
|
|
|
| 6 |
| 25 |
| 25 |
| 25 |
| hepatitis B | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| herpes zoster | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| pharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| amnesia | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| conjunctivitis | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| conjunctivitis allergic | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| keratoconjunctivitis sicca | Eye disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| dental caries | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| stomatitis | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| injection site erythema | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| injection site reaction | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| malaise | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| pyrexia | General disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| hepatic function abnormal | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| seasonal allergy | Immune system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| hordeolum | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| impetigo | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| oral herpes | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| pharyngitis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| hand fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| joint sprain | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| antinuclear antibody positive | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| DNA antibody positive | Investigations | MedDRA (11.0) | Non-systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| juvenile arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| eczema | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
Disclosure agreements vary; the Medical Institution shall not disclose any material/information disclosed by Abbott Japan in connection with the Clinical Research or information obtained by conducting the Clinical Research to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting Clinical Research, Institution shall obtain Abbott Japan's prior written approval.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Number of subjects achieving PedACR30 at Week 24 |
|
| Number of subjects achieving PedACR30 at Week 36 |
|
| Number of subjects achieving PedACR30 at Week 48 |
|
| Number of subjects achieving PedACR30 at Week 60 |
|
| Number of subjects achieving PedACR30 at Week 72 |
|
| Number of subjects achieving PedACR30 at Week 96 |
|
| Number of subjects achieving PedACR30 at Week 120 |
|
| Number of subjects achieving PedACR30 at Week 144 |
|
| Number of subjects achieving PedACR30- Final Visit |
|
| Number of subjects achieving PedACR50 at Week 2 |
|
| Number of subjects achieving PedACR50 at Week 4 |
|
| Number of subjects achieving PedACR50 at Week 8 |
|
| Number of subjects achieving PedACR50 at Week 24 |
|
| Number of subjects achieving PedACR50 at Week 36 |
|
| Number of subjects achieving PedACR50 at Week 48 |
|
| Number of subjects achieving PedACR50 at Week 60 |
|
| Number of subjects achieving PedACR50 at Week 72 |
|
| Number of subjects achieving PedACR50 at Week 96 |
|
| Number of subjects achieving PedACR50 at Week 120 |
|
| Number of subjects achieving PedACR50 at Week 144 |
|
| Number of subjects achieving PedACR50- Final Visit |
|
| Number of subjects achieving PedACR70 at Week 2 |
|
| Number of subjects achieving PedACR70 at Week 4 |
|
| Number of subjects achieving PedACR70 at Week 8 |
|
| Number of subjects achieving PedACR70 at Week 24 |
|
| Number of subjects achieving PedACR70 at Week 36 |
|
| Number of subjects achieving PedACR70 at Week 48 |
|
| Number of subjects achieving PedACR70 at Week 60 |
|
| Number of subjects achieving PedACR70 at Week 72 |
|
| Number of subjects achieving PedACR70 at Week 96 |
|
| Number of subjects achieving PedACR70 at Week 120 |
|
| Number of subjects achieving PedACR70 at Week 144 |
|
| Number of subjects achieving PedACR70- Final Visit |
|
| Title | Measurements |
|---|---|
|
| 20 mg dose at Week 16 |
|
| 20 mg dose at Week 24 |
|
| 20 mg dose at Week 36 |
|
| 20 mg dose at Week 48 |
|
| 20 mg dose at Week 60 |
|
| 40 mg dose at Week 2 |
|
| 40 mg dose at Week 4 |
|
| 40 mg dose at Week 8 |
|
| 40 mg dose at Week 16 |
|
| 40 mg dose at Week 24 |
|
| 40 mg dose at Week 36 |
|
| 40 mg dose at Week 48 |
|
| 40 mg dose at Week 60 |
|