Trial Outcomes & Findings for An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants (NCT NCT00760669)
NCT ID: NCT00760669
Last Updated: 2013-10-29
Results Overview
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).
COMPLETED
1061 participants
Baseline and Week 30
2013-10-29
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
1061
|
|
Overall Study
COMPLETED
|
1031
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Not assessed for overall improvement
|
18
|
|
Overall Study
Participants missing efficacy assessment
|
6
|
|
Overall Study
Participants with overlapping cases
|
1
|
|
Overall Study
Took drug before entering in contract
|
5
|
Baseline Characteristics
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Baseline characteristics by cohort
| Measure |
Participants Receiving Infliximab
n=1055 Participants
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.
|
|---|---|
|
Age Continuous
|
39.32 years
STANDARD_DEVIATION 13.84 • n=93 Participants
|
|
Sex: Female, Male
Female
|
363 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
692 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: 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.
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).
Outcome measures
| Measure |
Participants Receiving Infliximab
n=705 Participants
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.
|
|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
Baseline
|
7.52 Millimeter
Standard Deviation 6.68
|
|
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
Change at Week 30
|
-5.23 Millimeter
Standard Deviation 4.51
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: 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.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=248 Participants
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.
|
|---|---|
|
Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
Baseline
|
60.75 Millimeter per hour
Standard Deviation 29.84
|
|
Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
Change at Week 30
|
-21.80 Millimeter per hour
Standard Deviation 29.88
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: 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.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=262 Participants
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.
|
|---|---|
|
Change From Baseline in C-Reactive Protein (CRP) at Week 30
Baseline
|
7.94 Milligram per deciliter
Standard Deviation 14.04
|
|
Change From Baseline in C-Reactive Protein (CRP) at Week 30
Change at Week 30
|
-4.81 Milligram per deciliter
Standard Deviation 11.23
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: 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.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=239 Participants
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.
|
|---|---|
|
Change From Baseline in Number of Swollen Joints at Week 30
Baseline
|
9.75 Swollen joints
Standard Deviation 6.53
|
|
Change From Baseline in Number of Swollen Joints at Week 30
Change at Week 30
|
-5.46 Swollen joints
Standard Deviation 6.02
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: 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.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=240 Participants
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.
|
|---|---|
|
Change From Baseline in Number of Tender Joints at Week 30
Baseline
|
13.31 Tender joints
Standard Deviation 7.75
|
|
Change From Baseline in Number of Tender Joints at Week 30
Change at Week 30
|
-7.35 Tender joints
Standard Deviation 7.42
|
PRIMARY outcome
Timeframe: Baseline and Week 30Population: Data was not evaluated as only 1 participant with psoriatic arthritis was enrolled in this surveillance and no PASI evaluation was done for it.
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).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: The efficacy assessment analysis set included all participants who were assessed for 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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=1031 Participants
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 Efficacy Assessment
Improved
|
948 Participants
|
|
Overall Efficacy Assessment
Unchanged
|
59 Participants
|
|
Overall Efficacy Assessment
Aggravated
|
24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: Safety population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=1055 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
106 Participants
7.75
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
12 Participants
7.42
|
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: Safety population included all participants who received at least 1 dose of study medication.
Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=1055 Participants
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.
|
|---|---|
|
Number of Participants With Unexpected Adverse Events
|
28 Participants
7.42
|
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: Safety population included all participants who received at least 1 dose of study medication.
Adverse drug reactions are defined as adverse events for which the Investigator had not described the causal relationship to trial medication as "not related".
Outcome measures
| Measure |
Participants Receiving Infliximab
n=1055 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Drug Reactions
|
59 Participants
7.75
|
PRIMARY outcome
Timeframe: Baseline up to Week 30Population: Safety population included all participants who received at least 1 dose of study medication.
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.
Outcome measures
| Measure |
Participants Receiving Infliximab
n=1055 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction
|
48 Participants
|
Adverse Events
Participants Receiving Infliximab
Serious adverse events
| Measure |
Participants Receiving Infliximab
n=1055 participants at risk
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.
|
|---|---|
|
Infections and infestations
Cellulitis
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Disseminated tuberculosis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Pneumonia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Injury, poisoning and procedural complications
Spinal shock
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Eye disorders
Glaucoma
|
0.09%
1/1055 • Baseline up to 30 weeks
|
Other adverse events
| Measure |
Participants Receiving Infliximab
n=1055 participants at risk
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.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.57%
6/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.57%
6/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Folliculitis
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Chronic tonsillitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Latent tuberculosis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Oral herpes
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Pelvic abscess
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Pharyngotonsillitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Rhinitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Infections and infestations
Tinea cruris
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.66%
7/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.38%
4/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.38%
4/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.38%
4/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Gingivitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Investigations
Hepatic enzyme increased
|
1.1%
12/1055 • Baseline up to 30 weeks
|
|
Investigations
Blood pressure increased
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Investigations
Hepatic enzyme abnormal
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Investigations
LE cells present
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Chills
|
0.38%
4/1055 • Baseline up to 30 weeks
|
|
General disorders
Chest discomfort
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
General disorders
Asthenia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Chest pain
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Face oedema
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Fatigue
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Oedema peripheral
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
General disorders
Pyrexia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.38%
4/1055 • Baseline up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Nervous system disorders
Dizziness
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Nervous system disorders
Headache
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Vascular disorders
Hypertension
|
0.28%
3/1055 • Baseline up to 30 weeks
|
|
Vascular disorders
Flushing
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Vascular disorders
Hypotension
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Hepatobiliary disorders
Hepatitis
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.19%
2/1055 • Baseline up to 30 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.09%
1/1055 • Baseline up to 30 weeks
|
|
Social circumstances
Pregnancy of partner
|
0.09%
1/1055 • Baseline up to 30 weeks
|
Additional Information
Clinical Research Associate
Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER