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| ID | Type | Description | Link |
|---|---|---|---|
| REMICADEAKS4004 | Other Identifier | Janssen Korea, Ltd., Korea |
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The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.
This is an observational, prospective (study following participants forward in time) study to assess safety and efficacy of infliximab injection under post-marketing use and identify problems related to adverse events in participants with ankylosing spondylitis (chronic inflammatory condition affecting the axial joints), rheumatoid arthritis (chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures), psoriasis (scaly skin rash) and psoriatic arthritis (a type of inflammatory arthritis associated with psoriasis). Participants with rheumatoid arthritis will receive 6 doses of infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6 and will be observed for 30 weeks; and those with ankylosing spondylitis, psoriasis and psoriatic arthritis will also receive 6 doses of injection and will be observed for 24 to 30 weeks. Efficacy will be evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP), Psoriasis Area and Severity Index (PASI), swollen joint counts and tender joint count. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Infiximab | Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving infliximab injection will be observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab; observational study | Drug | This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2). | Baseline and Week 30 |
| Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation. | Baseline and Week 30 |
| Change From Baseline in C-Reactive Protein (CRP) at Week 30 | The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement. | Baseline and Week 30 |
| Change From Baseline in Number of Swollen Joints at Week 30 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen. |
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Inclusion Criteria:
Exclusion Criteria:
None
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Participant with ankylosing spondylitis, rheumatoid arthritis, psoriasis and psoriatic arthritis will be observed at rheumatology departments in university or general hospitals where they are commonly treated.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Infliximab | Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Methotrexate; observational study | Drug | Participants with RA will receive methotrexate based on physician's clinical judgement. |
|
| Baseline and Week 30 |
| Change From Baseline in Number of Tender Joints at Week 30 | Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe. | Baseline and Week 30 |
| Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 | The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Baseline and Week 30 |
| Overall Efficacy Assessment | The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion. | Baseline up to Week 30 |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Baseline up to Week 30 |
| Number of Participants With Unexpected Adverse Events | Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | Baseline up to Week 30 |
| Number of Participants With Adverse Drug Reactions | Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related". | Baseline up to Week 30 |
| Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together. | Baseline up to Week 30 |
| COMPLETED |
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| NOT COMPLETED |
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|
Baseline characteristics were performed on safety analysis set. Data presented only for 1055 participants as they were part of safety analysis set. Safety analysis set included all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Infliximab | Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively. |
| 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 |
|
| 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 | Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30 | The BASDAI is a validated self-assessment tool used to assess disease activity in participants with ankylosing spondylitis. It consists of 6 items measuring fatigue, spinal pain, joint pain, areas of localized tenderness, intensity of morning stiffness and duration of morning stiffness. First 5 items are scored on a 10 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm=none to 10 mm=severe; and sixth item is scored on VAS ranging from 0=0 hours to 10=2 or more hours. The total BASDAI score ranges from 0 (none) to 10 (very severe).To give each symptom equal weighting, the average of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score is divided by 5 to give a final BASDAI score. BASDAI total score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2). | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with ankylosing spondylitis and were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Millimeter | Baseline and Week 30 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30 | The ESR is a laboratory test that provides a non-specific measure of inflammation. It assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm per hour. A higher rate indicated inflammation. | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this outcome measure. | Posted | Mean | Standard Deviation | Millimeter per hour | Baseline and Week 30 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in C-Reactive Protein (CRP) at Week 30 | The CRP is acute serum protein released from liver. It is associated with low hemoglobin or erythropoetic resistance. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than 1 milligram per deciliter (mg/dl). A decrease in the level of CRP indicated reduction in inflammation and therefore improvement. | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Posted | Mean | Standard Deviation | Milligram per deciliter | Baseline and Week 30 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Number of Swollen Joints at Week 30 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 2, where 0=no swelling, 1=swelling, but bony landmarks seen and 2=swelling but bone marks not seen. | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Posted | Mean | Standard Deviation | Swollen joints | Baseline and Week 30 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Number of Tender Joints at Week 30 | Number of tender joints was determined by examination of 28 joints and identifying when tenderness was present. The number of tender joints was recorded on the joint assessment form at each visit and scored on a scale ranging from 0 to 3, where 0=no pain, 1=mild, 2= moderate and 3=severe. | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. Here 'N' (number of participants analyzed) signifies the participants who were diagnosed with rheumatoid arthritis or psoriatic arthritis and were evaluated for this measure. | Posted | Mean | Standard Deviation | Tender joints | Baseline and Week 30 |
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30 | The PASI is combined assessment of lesion severity and area affected into single score; range: 0=no disease to 72=maximal disease. Body is divided into 4 sections (head, arms, trunk and legs); each area is scored by itself and scores were combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, thickness, and scaling; scale: 0 (none) to 4 (severe). Final PASI=sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4). | Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it. | Posted | Baseline and Week 30 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Overall Efficacy Assessment | The level of improvement in symptom before and after the administration of the drug was assessed as per Investigator's discretion and the overall efficacy was assessed based on this result. The level of improvement in disease was assessed in three steps: improved, unchanged and aggravated as per Investigator's discretion. | The efficacy assessment analysis set included all participants who were assessed for efficacy assessment. | Posted | Number | Participants | Baseline up to Week 30 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline up to Week 30 |
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Unexpected Adverse Events | Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline up to Week 30 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Drug Reactions | Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related". | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline up to Week 30 |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Drug abuse is defined as the use of the study drug for a non-therapeutic effect, misuse was defined as use of the study medication in a way that was not prescribed and drug interaction was defined as a chemical or physiological reaction that can occur when 2 different drugs are taken together. | Safety population included all participants who received at least 1 dose of study medication. | Posted | Number | Participants | Baseline up to Week 30 |
|
Baseline up to 30 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Receiving Infliximab | Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving induction intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab at Week 0, 2, and 6 were observed. Dosage and infusion intervals of infliximab were employed in accordance to the summary of product characteristics: participants with RA received infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks along with methotrexate, participants with AS and PA received 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively. | 12 | 1,055 | 95 | 1,055 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Spinal shock | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| LE cells present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA Version 13.0 | Non-systematic Assessment |
|
Principal Investigator (PI) cannot provide any trial related information to external parties' without mutual agreement with the Sponsor. This is valid even after the contract is canceled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea | +82-2-2094-4879 |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| D001172 | Arthritis, Rheumatoid |
| D011565 | Psoriasis |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D019370 | Observation |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008722 | Methods |
| D008919 | Investigative Techniques |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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