| ID | Type | Description | Link |
|---|---|---|---|
| CNTO148JIA3001 | Other Identifier | Janssen Research & Development, LLC | |
| 2009-015019-42 | EudraCT Number |
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Trial has failed to meet primary - and major secondary endpoints
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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
Approximately 170 juvenile patients will take part in the study worldwide. All patients will receive 30mg/m2 (milligrams per meter squared, up to 50 mg per dose) of golimumab subcutaneously (injection under the skin) every 4 weeks from Week 0 through Week 12. At Week 16, patients who have shown at least a 30 percent improvement in their signs and symptoms from when they started the study will be randomized to receive either placebo (sham medicine injection) or 30 mg/m2 of golimumab injections every 4 weeks from week 16 through week 48. If a patient gets markedly worse and is receiving placebo injections, they will be restarted on golimumab at the next scheduled visit and will continue on golimumab. Patients can leave the study at any time without question. Between the Week 48 analyses timepoint to Week 144, which is subsequently amended to Week 248, all patients will receive golimumab 30mg/meter squared, unless, by measurements, they have been nearly cured (clinical remission) by being on placebo, whereby they will be discontinued from the study. Patients may have a change in background treatment after Week 48 based on therapeutic effect. Patients will continue active treatment after Week 48 in a long-term extension until Week 144, which is subsequently amended to Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. Safety will be monitored up to 152 week, which is subsequently amended to 256 weeks including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNTO 148 (Golimumab) | Experimental | All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response at Week 16 and who are randomly allocated to golimumab, will receive 30 mg per square meter every 4 weeks through Week 48. Patients will continue to receive golimumab 30 mg per square meter after Week 48 in a long-term extension until Week 248. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. |
|
| Placebo | Placebo Comparator | All patients will receive golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive placebo every 4 weeks through Week 48. However, patients receiving placebo and who will have lack/loss of clinical response will be eligible to receive golimumab 30 mg per square meter every 4 weeks through Week 48. At Week 48, patients do not have a clinical response will begin to receive golimumab 30 mg per square meter in a long-term extension until Week 248 and patients who have a clinical response will be discontinued from the study. All patients will receive their fixed dose of commercial methotrexate throughout the study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 148 (Golimumab) | Drug | Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. | Week 16 through Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28507219 | Derived | Brunner HI, Ruperto N, Tzaribachev N, Horneff G, Chasnyk VG, Panaviene V, Abud-Mendoza C, Reiff A, Alexeeva E, Rubio-Perez N, Keltsev V, Kingsbury DJ, Del Rocio Maldonado Velazquez M, Nikishina I, Silverman ED, Joos R, Smolewska E, Bandeira M, Minden K, van Royen-Kerkhof A, Emminger W, Foeldvari I, Lauwerys BR, Sztajnbok F, Gilmer KE, Xu Z, Leu JH, Kim L, Lamberth SL, Loza MJ, Lovell DJ, Martini A; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous golimumab for children with active polyarticular-course juvenile idiopathic arthritis: results of a multicentre, double-blind, randomised-withdrawal trial. Ann Rheum Dis. 2018 Jan;77(1):21-29. doi: 10.1136/annrheumdis-2016-210456. Epub 2017 May 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Participants Who Did Not Enter RW Period | Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48. |
|
| Methotrexate | Drug | All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration. |
|
| Week 16 through Week 48 |
| Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. | Week 16 through Week 48 |
| Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. | Week 16 through Week 48 |
| San Francisco |
| California |
| United States |
| Augusta | Georgia | United States |
| Boston | Massachusetts | United States |
| Durham | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Portland | Oregon | United States |
| Bregenz | Austria |
| Vienna | Austria |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Botucatu | Brazil |
| Curitiba | Brazil |
| Ribeirão Preto | Brazil |
| Rio de Janeiro | Brazil |
| Halifax | Nova Scotia | Canada |
| Toronto | Ontario | Canada |
| Helsinki | Finland |
| Oulu | Finland |
| Bad Bramstedt | Germany |
| Berlin | Germany |
| Bremen | Germany |
| Hamburg | Germany |
| Sankt Augustin | Germany |
| Vilnius | Lithuania |
| Mexico City | Mexico |
| Monterrey | Mexico |
| San Luis Potosà City | Mexico |
| Utrecht | Netherlands |
| Krakow | Poland |
| Lodz | Poland |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Samara | Russia |
| Group II: Placebo Subcutaneously (SC) + MTX |
Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48. |
| FG002 | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. |
| FG003 | Group IV: Golimumab + MTX | Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Participants Who Did Not Enter RW Period | Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16. |
| BG001 | Group II: Placebo Subcutaneously (SC) + MTX | Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48. |
| BG002 | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. |
| BG003 | Group IV: Golimumab + MTX | Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48 | Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. | Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16. | Posted | Number | Percentage of Participants | Week 16 through Week 48 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48 | Percentage of participants with ACR 30 response at Week 48 was calculated as number of participants with ACR 30 response at Week 48 divided by number of participants randomized. ACR Ped 30 response was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more than 30% at the time of the flare. The 6 variables are: physicians global assessment of disease, participants/parent global assessment of overall well-being, number of active joints (defined as either swelling, or in absence of swelling, limited range of motion associated with pain on motion or tenderness), number of joints with limited range of motion, physical function by childhood health assessment questionnaire, and erythrocyte sedimentation rate. | Intent-to-treat (ITT) population included all participants achieving American College of Rheumatology (ACR) Pediatric (Ped) 30 response who were randomized at Week 16. | Posted | Number | Percentage of Participants | Week 16 through Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48 | Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. | ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16. | Posted | Number | Percentage of Participants | Week 16 through Week 48 |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48 | Clinical remission while on medication for JIA is defined as inactive disease at each visit for a period of 6 months or more while on medication. Inactive disease is indicated by the presence of all of the following: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to juvenile idiopathic arthritis; no active uveitis (eye disease), normal erythrocyte sedimentation rate or C-reactive protein; physician global assessment of disease activity indicating no active disease; and duration of morning stiffness less than 15 minutes. | ITT population included all participants achieving ACR Ped 30 response who were randomized at Week 16. | Posted | Number | Percentage of Participants | Week 16 through Week 48 |
|
Day 1 up to Database lock [DBL] (approximately Week 184)
Safety population included all participants who received at least one dose of either placebo or golimumab. One participant in the placebo + MTX group received golimumab 30 mg/m^2 + MTX and was included in group 3 in safety population.
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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 | Group I: Participants Who Did Not Enter RW Period | Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16. | 4 | 19 | 14 | 19 | ||
| EG001 | Group II: Placebo Subcutaneously (SC) + MTX | Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48. | 2 | 10 | 9 | 10 | ||
| EG002 | Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX | Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. | 15 | 66 | 60 | 66 | ||
| EG003 | Group IV: Golimumab + MTX | Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48. | 18 | 78 | 68 | 78 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Gallbladder oedema | Hepatobiliary disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Hepatitis toxic | Hepatobiliary disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Somatoform disorder neurologic | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA Version 17.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA Version 17.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Erythema of eyelid | Eye disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Serositis | General disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA Version 17.0 | Systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Gingivitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDRA Version 17.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Research | Johnson & Johnson Pharmaceutical Research & Development | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Belgium |
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| Brazil |
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| Canada |
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| Finland |
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| Germany |
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| Lithuania |
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| Mexico |
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| Netherlands |
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| Poland |
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| Russian Federation |
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| United States |
|
| OG001 | CNTO 148 (Golimumab) | Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration. |
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|
Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration. |
|
|
| OG001 | CNTO 148 (Golimumab) | Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration. |
|
|