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An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

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ClinicalTrials.gov Identifier: NCT00760669
Recruitment Status : Completed
First Posted : September 26, 2008
Results First Posted : August 12, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Spondylitis, Ankylosing
Arthritis, Rheumatoid
Psoriasis
Arthritis, Psoriatic
Interventions Drug: Infliximab; observational study
Drug: Methotrexate; observational study
Enrollment 1061
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 1061
Completed 1031
Not Completed 30
Reason Not Completed
Not assessed for overall improvement             18
Participants missing efficacy assessment             6
Participants with overlapping cases             1
Took drug before entering in contract             5
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 1055
Hide Baseline Analysis Population Description
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.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1055 participants
39.32  (13.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1055 participants
Female
363
  34.4%
Male
692
  65.6%
1.Primary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
Hide Description 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).
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 705
Mean (Standard Deviation)
Unit of Measure: Millimeter
Baseline 7.52  (6.68)
Change at Week 30 -5.23  (4.51)
2.Primary Outcome
Title Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
Hide Description 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.
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: Millimeter per hour
Baseline 60.75  (29.84)
Change at Week 30 -21.80  (29.88)
3.Primary Outcome
Title Change From Baseline in C-Reactive Protein (CRP) at Week 30
Hide Description 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.
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 262
Mean (Standard Deviation)
Unit of Measure: Milligram per deciliter
Baseline 7.94  (14.04)
Change at Week 30 -4.81  (11.23)
4.Primary Outcome
Title Change From Baseline in Number of Swollen Joints at Week 30
Hide Description 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.
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 239
Mean (Standard Deviation)
Unit of Measure: Swollen joints
Baseline 9.75  (6.53)
Change at Week 30 -5.46  (6.02)
5.Primary Outcome
Title Change From Baseline in Number of Tender Joints at Week 30
Hide Description 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.
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 240
Mean (Standard Deviation)
Unit of Measure: Tender joints
Baseline 13.31  (7.75)
Change at Week 30 -7.35  (7.42)
6.Primary Outcome
Title Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30
Hide Description 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).
Time Frame Baseline and Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Overall Efficacy Assessment
Hide Description 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.
Time Frame Baseline up to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The efficacy assessment analysis set included all participants who were assessed for efficacy assessment.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1031
Measure Type: Number
Unit of Measure: Participants
Improved 948
Unchanged 59
Aggravated 24
8.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame Baseline up to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1055
Measure Type: Number
Unit of Measure: Participants
AEs 106
SAEs 12
9.Primary Outcome
Title Number of Participants With Unexpected Adverse Events
Hide Description Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Time Frame Baseline up to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1055
Measure Type: Number
Unit of Measure: Participants
28
10.Primary Outcome
Title Number of Participants With Adverse Drug Reactions
Hide Description Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as “not related”.
Time Frame Baseline up to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1055
Measure Type: Number
Unit of Measure: Participants
59
11.Primary Outcome
Title Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction
Hide Description 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.
Time Frame Baseline up to Week 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of study medication.
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 1055
Measure Type: Number
Unit of Measure: Participants
48
Time Frame Baseline up to 30 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants Receiving Infliximab
Hide Arm/Group Description 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.
All-Cause Mortality
Participants Receiving Infliximab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants Receiving Infliximab
Affected / at Risk (%)
Total   12/1055 (1.14%) 
Cardiac disorders   
Acute myocardial infarction * 1  1/1055 (0.09%) 
Eye disorders   
Glaucoma * 1  1/1055 (0.09%) 
Infections and infestations   
Cellulitis * 1  2/1055 (0.19%) 
Pulmonary tuberculosis * 1  2/1055 (0.19%) 
Disseminated tuberculosis * 1  1/1055 (0.09%) 
Gastroenteritis * 1  1/1055 (0.09%) 
Pneumonia * 1  1/1055 (0.09%) 
Injury, poisoning and procedural complications   
Extradural haematoma * 1  1/1055 (0.09%) 
Spinal fracture * 1  1/1055 (0.09%) 
Spinal shock * 1  1/1055 (0.09%) 
Tendon rupture * 1  1/1055 (0.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/1055 (0.09%) 
Back pain * 1  1/1055 (0.09%) 
Neck pain * 1  1/1055 (0.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants Receiving Infliximab
Affected / at Risk (%)
Total   95/1055 (9.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  2/1055 (0.19%) 
Cardiac disorders   
Palpitations * 1  1/1055 (0.09%) 
Eye disorders   
Ocular hyperaemia * 1  1/1055 (0.09%) 
Gastrointestinal disorders   
Dyspepsia * 1  4/1055 (0.38%) 
Abdominal pain * 1  3/1055 (0.28%) 
Epigastric discomfort * 1  3/1055 (0.28%) 
Nausea * 1  3/1055 (0.28%) 
Vomiting * 1  3/1055 (0.28%) 
Abdominal discomfort * 1  2/1055 (0.19%) 
Abdominal pain upper * 1  1/1055 (0.09%) 
Constipation * 1  1/1055 (0.09%) 
Diarrhoea * 1  1/1055 (0.09%) 
Gastric ulcer * 1  1/1055 (0.09%) 
Gingivitis * 1  1/1055 (0.09%) 
Haematochezia * 1  1/1055 (0.09%) 
Mouth ulceration * 1  1/1055 (0.09%) 
General disorders   
Chills * 1  4/1055 (0.38%) 
Chest discomfort * 1  3/1055 (0.28%) 
Asthenia * 1  1/1055 (0.09%) 
Chest pain * 1  1/1055 (0.09%) 
Face oedema * 1  1/1055 (0.09%) 
Fatigue * 1  1/1055 (0.09%) 
Oedema peripheral * 1  1/1055 (0.09%) 
Pyrexia * 1  1/1055 (0.09%) 
Hepatobiliary disorders   
Hepatitis * 1  1/1055 (0.09%) 
Hepatotoxicity * 1  1/1055 (0.09%) 
Immune system disorders   
Anaphylactic reaction * 1  1/1055 (0.09%) 
Infections and infestations   
Nasopharyngitis * 1  6/1055 (0.57%) 
Upper respiratory tract infection * 1  6/1055 (0.57%) 
Folliculitis * 1  2/1055 (0.19%) 
Arthritis bacterial * 1  1/1055 (0.09%) 
Bronchitis * 1  1/1055 (0.09%) 
Cellulitis * 1  1/1055 (0.09%) 
Chronic tonsillitis * 1  1/1055 (0.09%) 
Latent tuberculosis * 1  1/1055 (0.09%) 
Oral herpes * 1  1/1055 (0.09%) 
Pelvic abscess * 1  1/1055 (0.09%) 
Pharyngotonsillitis * 1  1/1055 (0.09%) 
Rhinitis * 1  1/1055 (0.09%) 
Tinea cruris * 1  1/1055 (0.09%) 
Injury, poisoning and procedural complications   
Contusion * 1  2/1055 (0.19%) 
Investigations   
Hepatic enzyme increased * 1  12/1055 (1.14%) 
Blood pressure increased * 1  1/1055 (0.09%) 
Hepatic enzyme abnormal * 1  1/1055 (0.09%) 
LE cells present * 1  1/1055 (0.09%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  2/1055 (0.19%) 
Hypercholesterolaemia * 1  1/1055 (0.09%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  3/1055 (0.28%) 
Back pain * 1  2/1055 (0.19%) 
Bursitis * 1  1/1055 (0.09%) 
Myalgia * 1  1/1055 (0.09%) 
Nervous system disorders   
Dizziness * 1  2/1055 (0.19%) 
Headache * 1  2/1055 (0.19%) 
Paraesthesia * 1  2/1055 (0.19%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  1/1055 (0.09%) 
Renal and urinary disorders   
Haematuria * 1  1/1055 (0.09%) 
Proteinuria * 1  1/1055 (0.09%) 
Reproductive system and breast disorders   
Amenorrhoea * 1  1/1055 (0.09%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  4/1055 (0.38%) 
Cough * 1  2/1055 (0.19%) 
Oropharyngeal pain * 1  1/1055 (0.09%) 
Productive cough * 1  1/1055 (0.09%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  7/1055 (0.66%) 
Pruritus * 1  4/1055 (0.38%) 
Rash * 1  4/1055 (0.38%) 
Rash generalised * 1  2/1055 (0.19%) 
Acne * 1  1/1055 (0.09%) 
Alopecia * 1  1/1055 (0.09%) 
Dermatitis atopic * 1  1/1055 (0.09%) 
Erythema * 1  1/1055 (0.09%) 
Skin exfoliation * 1  1/1055 (0.09%) 
Social circumstances   
Pregnancy of partner * 1  1/1055 (0.09%) 
Vascular disorders   
Hypertension * 1  3/1055 (0.28%) 
Flushing * 1  1/1055 (0.09%) 
Hypotension * 1  1/1055 (0.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
Phone: +82-2-2094-4879
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00760669     History of Changes
Other Study ID Numbers: CR100768
REMICADEAKS4004 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Submitted: September 24, 2008
First Posted: September 26, 2008
Results First Submitted: June 6, 2013
Results First Posted: August 12, 2013
Last Update Posted: October 29, 2013