Trial Outcomes & Findings for A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma (NCT NCT00207740)
NCT ID: NCT00207740
Last Updated: 2012-08-20
Results Overview
The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
309 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2012-08-20
Participant Flow
A total of 309 patients were randomized into 4 parallel treatment groups at 53 sites (134 patients at 27 sites in the US and 175 patients at 26 sites in Europe). The first patient was consented on 31 Aug 2004, and the last patient completed the study on 17 Jul 2007.
Participant milestones
| Measure |
Group I: Placebo
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
78
|
77
|
76
|
78
|
|
Overall Study
COMPLETED
|
49
|
36
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
29
|
41
|
40
|
43
|
Reasons for withdrawal
| Measure |
Group I: Placebo
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
14
|
14
|
11
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
1
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Sponsor Directive
|
22
|
15
|
16
|
21
|
|
Overall Study
Other
|
2
|
10
|
7
|
5
|
Baseline Characteristics
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
Baseline characteristics by cohort
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
49.4 years
STANDARD_DEVIATION 12.03 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
49.1 years
STANDARD_DEVIATION 12.85 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 12.26 • n=4 Participants
|
50.1 years
STANDARD_DEVIATION 12.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
173 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
136 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using Last Observation Carried Forward (LOCF).
The endpoint is change from baseline in prebronchodilator clinic-measured percent predicted Percent-Predicted Forced Expiratory Volume in 1 Second (FEV1) with Last Observation Carried Forward (LOCF) at 6 months. The baseline visit starts at the end of 2 weeks run in phase.
Outcome measures
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=154 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second
|
2.44 Percent predicted
Interval -0.574 to 5.461
|
0.48 Percent predicted
Interval -2.563 to 3.519
|
3.22 Percent predicted
Interval 0.149 to 6.295
|
2.59 Percent predicted
Interval -0.441 to 5.62
|
2.91 Percent predicted
Interval 0.696 to 5.116
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: The analysis of this endpoint uses intent-to-treat population. For the dropouts, the worst case in similar patients was used as the number of severe exacerbations.
The endpoint is the average number of severe asthma exacerbations per patient from baseline through 6 months.
Outcome measures
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=154 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months
|
0.5 Events per patient through week (Wk) 24
Standard Deviation 1.07 • Interval 0.0 to 1.0
|
0.7 Events per patient through week (Wk) 24
Standard Deviation 1.18 • Interval 0.0 to 1.0
|
0.4 Events per patient through week (Wk) 24
Standard Deviation 0.85 • Interval 0.0 to 0.5
|
0.5 Events per patient through week (Wk) 24
Standard Deviation 1.08 • Interval 0.0 to 1.0
|
0.5 Events per patient through week (Wk) 24
Standard Deviation 0.97 • Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.
The endpoint is the change from baseline in the overall Asthma Quality of Life Questionnaire (AQLQ) score at 6 months. The AQLQ is a validated and self-administered questionnaire to evaluate symptoms and Quality of Life (QOL) in subjects with asthma and it has 32 questions in 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants were asked to score the importance of each of the positively identified problems on a 7-point scale (7 = not impaired at all - 1 = severely impaired).
Outcome measures
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=154 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Change From Baseline in Asthma Quality of Life Questionnaire Score at 6 Months; Randomized Patients
|
0.42 Points on scale
Interval 0.0 to 1.13
|
0.53 Points on scale
Interval 0.0 to 1.13
|
0.86 Points on scale
Interval -0.02 to 1.47
|
0.55 Points on scale
Interval 0.0 to 1.0
|
0.66 Points on scale
Interval 0.0 to 1.34
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward.
The endpoint is change from baseline in rescue medication use at Wk 24 where the rescue medication use was based on the average over 7 days prior to visit.
Outcome measures
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=154 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Change From Baseline in Rescue Medication Use at 6 Months; Randomized Patients
|
-0.54 Puffs/day
Interval -1.57 to 0.5
|
-0.71 Puffs/day
Interval -1.71 to 0.52
|
-0.29 Puffs/day
Interval -1.79 to 0.26
|
-0.14 Puffs/day
Interval -1.67 to 0.67
|
-0.21 Puffs/day
Interval -1.71 to 0.57
|
SECONDARY outcome
Timeframe: Week 24 to Week 52Population: Analysis of this endpoint only includes patients (pts) who did not discontinue study participation prior to Wk 24. For the dropouts during the period between Wks 24- 52, worst case in similar pts was used as the number of severe exacerbations. Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various study timepoints
The endpoint is the average number of severe asthma exacerbations per patient from Week (Wk) 24 through Wk 52 for the patients who did not discontinue study participation prior to Wk 24
Outcome measures
| Measure |
Group I: Placebo
n=77 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=68 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=71 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=74 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=145 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Number of Severe Asthma Exacerbations Per Patient From Week 24 Through Week 52; Randomized Patients Who Did Not Discontinue Study Participation Prior to Week 24
|
0.6 Events per patient from Wk 24 thru Wk 52
Standard Deviation 1.02 • Interval 0.0 to 1.0
|
0.8 Events per patient from Wk 24 thru Wk 52
Standard Deviation 1.23 • Interval 0.0 to 2.0
|
0.9 Events per patient from Wk 24 thru Wk 52
Standard Deviation 1.18 • Interval 0.0 to 2.0
|
0.8 Events per patient from Wk 24 thru Wk 52
Standard Deviation 1.01 • Interval 0.0 to 2.0
|
0.9 Events per patient from Wk 24 thru Wk 52
Standard Deviation 1.09 • Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Analysis of this endpoint includes only pts who received OCS at baseline.Wk 52 OCS dose is the daily OCS dose in the last period, defined as between 2 consecutive visits, in which no change in total daily dose of OCS occurred, prior to Wk 52 visit.Data from Wk 24-52 must be interpreted with caution as study agent was stopped at various timepoints.
The endpoint is the change from baseline at Week (Wk) 52 in oral corticosteroids (OCS) dose for the randomized patients who received OCS at baseline.
Outcome measures
| Measure |
Group I: Placebo
n=25 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=25 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=25 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=24 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=49 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Change From Baseline in Oral Corticosteroids Dose at Week 52; Randomized Patients Who Received Oral Corticosteroids at Baseline
|
-5.000 mg/day P. Eq.
Interval -10.0 to 0.0
|
0.000 mg/day P. Eq.
Interval -5.0 to 0.0
|
-4.550 mg/day P. Eq.
Interval -10.0 to 0.0
|
-3.750 mg/day P. Eq.
Interval -10.0 to 0.0
|
-4.550 mg/day P. Eq.
Interval -10.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The analysis of this endpoint uses intent-to-treat population. Missing data were imputed using last observation carried forward (LOCF).
The endpoint is the change from baseline in domiciliary morning PEFR at Week 24. PEFR- Peak Expiratory Flow Rate (PEFR): A measure of the speed of exhalation. The data were collected in the eDiary which was issued to each participant at screening. PEFR was collected morning and evening each day of the study.
Outcome measures
| Measure |
Group I: Placebo
n=78 Participants
Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
|
Group II: Golimumab 50 mg
n=77 Participants
Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
|
Group III: Golimumab 100 mg
n=76 Participants
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 Participants
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
|
Combined: Group III & IV
n=154 Participants
Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
|
|---|---|---|---|---|---|
|
Change From Baseline in Domiciliary Morning Peak Expiratory Flow Rate (PEFR) at 6 Months; Randomized Subjects
|
4.730 L/min
Standard Deviation 60.9136
|
8.102 L/min
Standard Deviation 58.0602
|
3.488 L/min
Standard Deviation 60.1336
|
2.475 L/min
Standard Deviation 59.7923
|
2.975 L/min
Standard Deviation 59.7668
|
Adverse Events
Group I: Placebo
Serious events: 16 serious events
Other events: 75 other events
Deaths: 0 deaths
Group II: Golimumab 50 mg
Serious events: 24 serious events
Other events: 68 other events
Deaths: 0 deaths
Group III: Golimumab 100 mg
Serious events: 24 serious events
Other events: 75 other events
Deaths: 0 deaths
Group IV: Golimumab 200 mg
Serious events: 22 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Placebo
n=78 participants at risk
Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
|
Group II: Golimumab 50 mg
n=75 participants at risk
Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
|
Group III: Golimumab 100 mg
n=78 participants at risk
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 participants at risk
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
9.0%
7/78
|
16.0%
12/75
|
7.7%
6/78
|
11.5%
9/78
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse panbronchiolitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Pneumonia
|
1.3%
1/78
|
4.0%
3/75
|
6.4%
5/78
|
2.6%
2/78
|
|
Infections and infestations
Cellulitis
|
0.00%
0/78
|
1.3%
1/75
|
1.3%
1/78
|
2.6%
2/78
|
|
Infections and infestations
Sepsis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
2.6%
2/78
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Bronchitis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Choriomeningitis lymphocytic
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Septic shock
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Infections and infestations
Sinusitis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Immune system disorders
Staphylococcal bacteraemia
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Infections and infestations
Postoperative wound infection
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Abdominal hernia
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
General disorders
Chest pain
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
2.6%
2/78
|
|
General disorders
Pyrexia
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
1.3%
1/78
|
|
General disorders
Hyperthermia
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
2.6%
2/78
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/78
|
1.3%
1/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/78
|
1.3%
1/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Nervous system disorders
Syncope
|
1.3%
1/78
|
1.3%
1/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Nervous system disorders
Headache
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
1.3%
1/78
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Immune system disorders
Serum sickness
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/78
|
1.3%
1/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/78
|
0.00%
0/75
|
1.3%
1/78
|
0.00%
0/78
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/78
|
0.00%
0/75
|
0.00%
0/78
|
1.3%
1/78
|
|
Eye disorders
Retinal detachment
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Eye disorders
Vision blurred
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
|
Psychiatric disorders
Borderline personality disorder
|
1.3%
1/78
|
0.00%
0/75
|
0.00%
0/78
|
0.00%
0/78
|
Other adverse events
| Measure |
Group I: Placebo
n=78 participants at risk
Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
|
Group II: Golimumab 50 mg
n=75 participants at risk
Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
|
Group III: Golimumab 100 mg
n=78 participants at risk
Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
|
Group IV: Golimumab 200 mg
n=78 participants at risk
Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
91.0%
71/78
|
85.3%
64/75
|
88.5%
69/78
|
92.3%
72/78
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
3/78
|
2.7%
2/75
|
6.4%
5/78
|
3.8%
3/78
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
4/78
|
2.7%
2/75
|
5.1%
4/78
|
3.8%
3/78
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.1%
4/78
|
2.7%
2/75
|
3.8%
3/78
|
5.1%
4/78
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
3/78
|
0.00%
0/75
|
5.1%
4/78
|
5.1%
4/78
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.1%
4/78
|
4.0%
3/75
|
5.1%
4/78
|
1.3%
1/78
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/78
|
6.7%
5/75
|
0.00%
0/78
|
2.6%
2/78
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/78
|
0.00%
0/75
|
5.1%
4/78
|
2.6%
2/78
|
|
Infections and infestations
Sinusitis
|
11.5%
9/78
|
25.3%
19/75
|
21.8%
17/78
|
12.8%
10/78
|
|
Infections and infestations
Upper respiratory tract infection
|
20.5%
16/78
|
9.3%
7/75
|
17.9%
14/78
|
15.4%
12/78
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
10/78
|
12.0%
9/75
|
10.3%
8/78
|
15.4%
12/78
|
|
Infections and infestations
Bronchitis
|
10.3%
8/78
|
5.3%
4/75
|
16.7%
13/78
|
12.8%
10/78
|
|
Infections and infestations
Rhinitis
|
6.4%
5/78
|
4.0%
3/75
|
6.4%
5/78
|
7.7%
6/78
|
|
Infections and infestations
Oral candidiasis
|
2.6%
2/78
|
4.0%
3/75
|
5.1%
4/78
|
5.1%
4/78
|
|
Infections and infestations
Influenza
|
5.1%
4/78
|
1.3%
1/75
|
6.4%
5/78
|
5.1%
4/78
|
|
Infections and infestations
Pneumonia
|
3.8%
3/78
|
5.3%
4/75
|
3.8%
3/78
|
3.8%
3/78
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/78
|
1.3%
1/75
|
1.3%
1/78
|
6.4%
5/78
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/78
|
1.3%
1/75
|
1.3%
1/78
|
5.1%
4/78
|
|
Infections and infestations
Acute sinusitis
|
9.0%
7/78
|
2.7%
2/75
|
1.3%
1/78
|
1.3%
1/78
|
|
General disorders
Injection site erythema
|
0.00%
0/78
|
2.7%
2/75
|
5.1%
4/78
|
5.1%
4/78
|
|
General disorders
Pyrexia
|
1.3%
1/78
|
0.00%
0/75
|
5.1%
4/78
|
5.1%
4/78
|
|
General disorders
Chest pain
|
6.4%
5/78
|
0.00%
0/75
|
1.3%
1/78
|
1.3%
1/78
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
4/78
|
5.3%
4/75
|
7.7%
6/78
|
3.8%
3/78
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
2/78
|
6.7%
5/75
|
5.1%
4/78
|
3.8%
3/78
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
3/78
|
5.3%
4/75
|
5.1%
4/78
|
3.8%
3/78
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/78
|
1.3%
1/75
|
5.1%
4/78
|
3.8%
3/78
|
|
Gastrointestinal disorders
Nausea
|
1.3%
1/78
|
2.7%
2/75
|
7.7%
6/78
|
3.8%
3/78
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.3%
1/78
|
2.7%
2/75
|
1.3%
1/78
|
5.1%
4/78
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
5/78
|
2.7%
2/75
|
1.3%
1/78
|
5.1%
4/78
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.6%
2/78
|
2.7%
2/75
|
5.1%
4/78
|
2.6%
2/78
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
4/78
|
1.3%
1/75
|
5.1%
4/78
|
3.8%
3/78
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.4%
5/78
|
2.7%
2/75
|
2.6%
2/78
|
3.8%
3/78
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
4/78
|
1.3%
1/75
|
1.3%
1/78
|
1.3%
1/78
|
|
Nervous system disorders
Headache
|
6.4%
5/78
|
6.7%
5/75
|
7.7%
6/78
|
7.7%
6/78
|
|
Nervous system disorders
Migraine
|
0.00%
0/78
|
2.7%
2/75
|
0.00%
0/78
|
5.1%
4/78
|
|
Injury, poisoning and procedural complications
Contusion
|
1.3%
1/78
|
1.3%
1/75
|
5.1%
4/78
|
3.8%
3/78
|
Additional Information
Director Clinical Research
Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER