Trial Outcomes & Findings for A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (NCT NCT01177800)
NCT ID: NCT01177800
Last Updated: 2014-09-12
Results Overview
The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
129 participants
Primary outcome timeframe
Week 10
Results posted on
2014-09-12
Participant Flow
Participant milestones
| Measure |
Infliximab
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
45
|
|
Overall Study
COMPLETED
|
74
|
40
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Infliximab
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal of informed consent
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Safety and Efficacy of Infliximab in Chinese Participants With Moderate to Severe Plaque-type Psoriasis
Baseline characteristics by cohort
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.4 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 10Population: Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group.
The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders.
Outcome measures
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI)
|
81 percentage of participants
|
2.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 10Population: ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points.
The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Outcome measures
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10
Baseline (n= 84,45)
|
14.4 units on a scale
Standard Deviation 6.2
|
14.4 units on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10
Change at Week 10 (n= 82,44)
|
-8.0 units on a scale
Standard Deviation 7.1
|
-1.5 units on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Week 10Population: ITT population included all participants randomly assigned to Infliximab or placebo group.
The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score \<= 1 at week 10 were reported.
Outcome measures
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10
|
88.1 percentage of participants
|
6.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 26Population: ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points.
The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
Outcome measures
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26
Baseline (n= 84,45)
|
14.4 units on a scale
Standard Deviation 6.2
|
14.4 units on a scale
Standard Deviation 6.3
|
|
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26
Change at Week 26 (n= 80,42)
|
-10.3 units on a scale
Standard Deviation 7.8
|
-9.2 units on a scale
Standard Deviation 6.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to end of study (Week 26)Population: Safety Population included all participants randomly assigned to infliximab or placebo group.
The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent's genetic input) anomaly.
Outcome measures
| Measure |
Infliximab
n=84 Participants
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 Participants
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
AEs
|
59 participants
|
29 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
SAE
|
4 participants
|
1 participants
|
Adverse Events
Infliximab
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infliximab
n=84 participants at risk
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 participants at risk
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Infections and infestations
Pulmonary Tuberculosis
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Tuberculous pleurisy
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pancreatic Cancer
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Hepatobiliary disorders
Liver diseases
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
Other adverse events
| Measure |
Infliximab
n=84 participants at risk
5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
|
Placebo
n=45 participants at risk
Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Antinuclear antibody positive
|
11.9%
10/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
6.7%
3/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Alanine aminotransferase increased
|
10.7%
9/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
6.7%
3/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
White blood cell count decreased
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
6.7%
3/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Double stranded DNA antibody positive
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Blood uric acid increased
|
3.6%
3/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Electrocardiogram T wave abnormal
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Neutrophil count decreased
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Blood bilirubin increased
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Bilirubin conjugated increased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Blood glucose increased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Blood potassium decreased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Electrocardiogram abnormal
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Lipids increased
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Transaminases increased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Investigations
Weight decreased
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
12/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
11.1%
5/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
3/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
11.1%
5/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Furuncle
|
3.6%
3/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Folliculitis
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Tonsillitis
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Pelvic infection
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Skin infection
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Infections and infestations
Tinea pedis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Asthenia
|
11.9%
10/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
11.1%
5/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Chest discomfort
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Pyrexia
|
3.6%
3/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Fatigue
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Influenza like illness
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Chest pain
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Face oedema
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
General disorders
Malaise
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Cheilitis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Enteritis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
6/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Nervous system disorders
Dizziness
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Nervous system disorders
Headache
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Nervous system disorders
Somnolence
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.6%
3/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.8%
4/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
4.4%
2/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Cardiac disorders
Palpitations
|
2.4%
2/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Cardiac disorders
Sinus bradycardia
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Nervous system disorders
Apraxia
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Vascular disorders
Hypertension
|
1.2%
1/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
0.00%
0/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
|
Hepatobiliary disorders
Effulgent liver fire
|
0.00%
0/84 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
2.2%
1/45 • Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on placebo).
|
Additional Information
Senior Therapeutic Area Physician
Beijing, China R&D
Phone: +86 010 58218358
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60