Trial Outcomes & Findings for An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis (NCT NCT00267956)
NCT ID: NCT00267956
Last Updated: 2013-06-05
Results Overview
ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
Week 0 to Week 12
Results posted on
2013-06-05
Participant Flow
146 participants were randomly assigned to receive either placebo or ustekinumab (CNTO 1275) at 24 sites in North America and Europe.
Participant milestones
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab x 4 (CP)
Controlled period (Week 0-12) - Ustekinumab x 4 Group
|
Placebo -> Ustekinumab (After CP)
After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -\> receiving ustekinumab at Week 12 and Week 16
|
Ustekinumab x 4 (After CP)
After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -\> receiving Placebo at Week 12 and Week 16
|
|---|---|---|---|---|
|
Controlled Period
STARTED
|
70
|
76
|
0
|
0
|
|
Controlled Period
COMPLETED
|
57
|
72
|
0
|
0
|
|
Controlled Period
NOT COMPLETED
|
13
|
4
|
0
|
0
|
|
After Controlled Period
STARTED
|
0
|
0
|
57
|
72
|
|
After Controlled Period
COMPLETED
|
0
|
0
|
52
|
70
|
|
After Controlled Period
NOT COMPLETED
|
0
|
0
|
5
|
2
|
Reasons for withdrawal
| Measure |
Placebo (CP)
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab x 4 (CP)
Controlled period (Week 0-12) - Ustekinumab x 4 Group
|
Placebo -> Ustekinumab (After CP)
After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -\> receiving ustekinumab at Week 12 and Week 16
|
Ustekinumab x 4 (After CP)
After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -\> receiving Placebo at Week 12 and Week 16
|
|---|---|---|---|---|
|
Controlled Period
Adverse Event
|
4
|
1
|
0
|
0
|
|
Controlled Period
Lack of Efficacy
|
4
|
2
|
0
|
0
|
|
Controlled Period
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Controlled Period
Withdrew consent
|
3
|
1
|
0
|
0
|
|
After Controlled Period
Adverse Event
|
0
|
0
|
2
|
1
|
|
After Controlled Period
Lack of Efficacy
|
0
|
0
|
1
|
1
|
|
After Controlled Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
After Controlled Period
Withdrew consent
|
0
|
0
|
1
|
0
|
Baseline Characteristics
An Effectiveness and Safety Study of CNTO 1275 in Patients With Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Group I: Placebo
n=70 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=76 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
47.1 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 to Week 12Population: Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
ACR 20 response is an improvement of greater than or equal to 20 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Outcome measures
| Measure |
Group I: Placebo
n=70 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=76 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12
|
10 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to treat. All participants randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
ACR 50 response is an improvement of greater than or equal to 50 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Outcome measures
| Measure |
Group I: Placebo
n=70 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=76 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12
|
5 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to treat. All participant randomized were included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy or participant who have no data for all ACR components at Week 12.
ACR 70 response is an improvement of greater than or equal to 70 percentage in both tender and swollen joint count and in 3 to 5 assessments (patient's assessment of pain visual analog scale \[VAS\] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively\]; Health Assessment Questionnaire \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; C-reactive protein\[CRP\]).
Outcome measures
| Measure |
Group I: Placebo
n=70 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=76 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Number of Participants With an American College of Rheumatology (ACR) 70 Response at Week 12
|
0 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: Participants were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.
The HAQ is a 20-question instrument assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area are scored from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area based on the worst score from the questions that pertain to that task. The HAQ score is determined by the average of the 8 scores.
Outcome measures
| Measure |
Group I: Placebo
n=64 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=75 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Change in Health Assessment Questionnaire (HAQ) at Week 12
|
0.00 Scores on scale
Interval -0.25 to 0.13
|
-0.25 Scores on scale
Interval -0.5 to 0.0
|
SECONDARY outcome
Timeframe: Week 12Population: All participants randomized with baseline ≥ 3% body surface area (BSA) psoriatic involvement and with evaluable measurement are included in the analysis according to the assigned treatment groups. Participant is considered a non- responder if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy.
Number of participants achieving greater than or equal to 75 perccentage mprovement PASI at Week 12. PASI is widely used tool for the measurement of severity of psoriasis. This is a test of how bad person's psoriasis is. The combine redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
Outcome measures
| Measure |
Group I: Placebo
n=55 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=63 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Number of Participants With Psoriasis Area and Severity Index (PASI) Score of 75 Percent at Week 12
|
3 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Week 0 to Week 12Population: All participants randomized with baseline ≥ 3% body surface area psoriatic involvement were included in the analysis according to the assigned treatment groups. Zero change is imputed if the participant has used any pre-specified prohibited medications or discontinued due to lack of efficacy. Other missing data were not imputed.
Change in Dermatology Life Quality Index (DLQI) from baseline at Week 12. The DLQI is a 10 item questionnaire, is designed to assess the impact of the disease on a participant's quality of life, can be used to assess 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The score ranges from 0 (better quality of life) to 30 (worse quality of life).
Outcome measures
| Measure |
Group I: Placebo
n=55 Participants
Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
|
Group II: Ustekinumab x 4
n=63 Participants
Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
|
|---|---|---|
|
Change in Dermatology Life Quality Index (DLQI) at Week 12
|
0.00 Scores on scale
Interval -4.0 to 2.0
|
-6.0 Scores on scale
Interval -14.0 to -3.0
|
Adverse Events
Placebo (CP)
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Ustekinumab x 4 (CP)
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo -> Ustekinumab (After CP)
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Ustekinumab x 4 (After CP)
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (CP)
n=70 participants at risk
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab x 4 (CP)
n=76 participants at risk
Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
|
Placebo -> Ustekinumab (After CP)
n=57 participants at risk
After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -\> receiving ustekinumab at Week 12 and Week 16
|
Ustekinumab x 4 (After CP)
n=74 participants at risk
After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -\> receiving Placebo at Week 12 and Week 16
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
1.4%
1/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
General disorders
Chest pain
|
1.4%
1/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.4%
1/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Nervous system disorders
Syncope
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.4%
1/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Vascular disorders
Hypertension
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
Other adverse events
| Measure |
Placebo (CP)
n=70 participants at risk
Controlled period (Week 0-12) - Placebo Group
|
Ustekinumab x 4 (CP)
n=76 participants at risk
Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
|
Placebo -> Ustekinumab (After CP)
n=57 participants at risk
After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -\> receiving ustekinumab at Week 12 and Week 16
|
Ustekinumab x 4 (After CP)
n=74 participants at risk
After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -\> receiving Placebo at Week 12 and Week 16
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.9%
2/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
6.6%
5/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
3.5%
2/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
2.7%
2/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
2.6%
2/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
5.3%
3/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.4%
1/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
0.00%
0/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
5.3%
3/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
2.7%
2/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Influenza
|
5.7%
4/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.3%
1/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
3.5%
2/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
4.1%
3/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
10.5%
8/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
7.0%
4/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
2.7%
2/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.3%
1/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
5.3%
3/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
4.1%
3/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
6/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
13.2%
10/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
10.5%
6/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
9.5%
7/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Investigations
C-reactive protein increased
|
1.4%
1/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.3%
1/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
3.5%
2/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
6.8%
5/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.3%
1/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.8%
1/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
5.4%
4/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
|
Nervous system disorders
Headache
|
5.7%
4/70 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
6.6%
5/76 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
3.5%
2/57 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
1.4%
1/74 • 36 weeks
2 participants discontinued study agent during the controlled period (CP) but had follow-up after CP and hence are included in the tables of frequent adverse events and serious adverse events after CP.
|
Additional Information
Senior 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