Trial Outcomes & Findings for A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate (NCT NCT01059773)
NCT ID: NCT01059773
Last Updated: 2014-11-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
490 participants
Primary outcome timeframe
from week 0 to week 12
Results posted on
2014-11-24
Participant Flow
One patient received on-study methotrexate only but no ustekinumab and was therefore excluded from the analysis.
Participant milestones
| Measure |
UST / MTX Stopped
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
244
|
245
|
|
Overall Study
COMPLETED
|
224
|
221
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
Reasons for withdrawal
| Measure |
UST / MTX Stopped
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Protocol Violation
|
6
|
2
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Malignancy including squamous cell skin
|
0
|
1
|
|
Overall Study
Ineligible follow TB screening criteria
|
0
|
1
|
|
Overall Study
Other
|
1
|
3
|
Baseline Characteristics
A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate
Baseline characteristics by cohort
| Measure |
UST / MTX Stopped
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn
n=245 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
46.2 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Age, Customized
18-29 years
|
29 participants
n=5 Participants
|
20 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
57 participants
n=5 Participants
|
48 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
69 participants
n=5 Participants
|
75 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
56 participants
n=5 Participants
|
60 participants
n=7 Participants
|
116 participants
n=5 Participants
|
|
Age, Customized
>=60 years
|
33 participants
n=5 Participants
|
42 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=5 Participants
|
162 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Weight, Categorized
<= 100 kg
|
195 participants
n=5 Participants
|
196 participants
n=7 Participants
|
391 participants
n=5 Participants
|
|
Weight, Categorized
> 100 kg
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from week 0 to week 12Population: All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=245 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12
|
149 participants
|
158 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: at week 12, 16, 28 40 and 52Population: All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information.
The number of patients with any of the following Treatment Emergent AEs (TEAEs) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and \>100 kg): AE; SAE and Death.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=195 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
n=196 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any serious TEAE: through week 28
|
7 Number of patients
|
4 Number of patients
|
10 Number of patients
|
3 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any serious TEAE: through week 40
|
10 Number of patients
|
4 Number of patients
|
14 Number of patients
|
3 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any serious TEAE: through week 52
|
15 Number of patients
|
5 Number of patients
|
15 Number of patients
|
5 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any serious TEAE: through week 16
|
6 Number of patients
|
4 Number of patients
|
6 Number of patients
|
3 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any TEAE: through week 12
|
116 Number of patients
|
33 Number of patients
|
124 Number of patients
|
34 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any TEAE: through week 16
|
127 Number of patients
|
35 Number of patients
|
135 Number of patients
|
40 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any TEAE: through week 28
|
141 Number of patients
|
39 Number of patients
|
147 Number of patients
|
42 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any TEAE: through week 40
|
149 Number of patients
|
40 Number of patients
|
160 Number of patients
|
44 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any TEAE: through week 52
|
155 Number of patients
|
40 Number of patients
|
162 Number of patients
|
46 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any serious TEAE: through week 12
|
5 Number of patients
|
2 Number of patients
|
3 Number of patients
|
3 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any Death: through week 12
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any Death: through week 16
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any Death: through week 28
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any Death: through week 40
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
|
Rate of Adverse Events (AEs), Serious AEs (SAEs) and Deaths During the Study Period
Any Death: through week 52
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
SECONDARY outcome
Timeframe: at week 12, 16, 28 40 and 52Population: All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and \>100 kg): AE with severe intensity; AE or SAE reasonably related to ustekinumab (i.e., AEs classified by the investigator as 'possibly', 'probably', or 'very likely' related to study agent); AE or SAE leading to permanent discontinuation of ustekinumab.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=195 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
n=196 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Permanently discontinued UST due to AE: week 52
|
2 Number of patients
|
2 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any severe TEAE: through week 12
|
11 Number of patients
|
2 Number of patients
|
5 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any severe TEAE: through week 16
|
11 Number of patients
|
3 Number of patients
|
5 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any severe TEAE: through week 28
|
11 Number of patients
|
3 Number of patients
|
7 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE: through week 40
|
14 Number of patients
|
4 Number of patients
|
12 Number of patients
|
1 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any severe TEAE: through week 52
|
18 Number of patients
|
5 Number of patients
|
13 Number of patients
|
3 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE related to UST: through week 12
|
41 Number of patients
|
10 Number of patients
|
43 Number of patients
|
13 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE related to UST: through week 16
|
46 Number of patients
|
11 Number of patients
|
46 Number of patients
|
14 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE related to UST: through week 28
|
47 Number of patients
|
15 Number of patients
|
49 Number of patients
|
15 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE related to UST: through week 40
|
54 Number of patients
|
17 Number of patients
|
60 Number of patients
|
17 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any TEAE related to UST: through week 52
|
56 Number of patients
|
17 Number of patients
|
60 Number of patients
|
18 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any Serious TEAE related to UST through week 12
|
0 Number of patients
|
1 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any Serious TEAE related to UST through week 16
|
0 Number of patients
|
1 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any Serious TEAE related to UST through week 28
|
0 Number of patients
|
1 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any Serious TEAE related to UST through week 40
|
0 Number of patients
|
1 Number of patients
|
4 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Any Serious TEAE related to UST through week 52
|
1 Number of patients
|
1 Number of patients
|
4 Number of patients
|
1 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Permanently discontinued UST due to AE: week 12
|
2 Number of patients
|
1 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Permanently discontinued UST due to AE: week 16
|
2 Number of patients
|
2 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Permanently discontinued UST due to AE: week 28
|
2 Number of patients
|
2 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Severe AEs, Reasonably Related AEs, and AEs Leading to Discontination During the Study Period
Permanently discontinued UST due to AE: week 40
|
2 Number of patients
|
2 Number of patients
|
2 Number of patients
|
0 Number of patients
|
SECONDARY outcome
Timeframe: at week 12, 16, 28 40 and 52Population: All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
The number of patients with any of the following TEAEs were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and \>100 kg): infections, serious infections, and infections requiring oral or parenteral antimicrobial treatment (infections being considered any event that by the investigator was indicated as infection on the CRF).
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=195 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
n=196 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any treatment-emergent (TE) infection: week 12
|
36 Number of patients
|
13 Number of patients
|
42 Number of patients
|
11 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any TE infection: week 16
|
43 Number of patients
|
14 Number of patients
|
50 Number of patients
|
13 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any TE infection: week 28
|
55 Number of patients
|
18 Number of patients
|
68 Number of patients
|
19 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any TE infection: week 40
|
61 Number of patients
|
21 Number of patients
|
76 Number of patients
|
23 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any TE infection: week 52
|
64 Number of patients
|
22 Number of patients
|
81 Number of patients
|
23 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any serious TE infection: through week 12
|
0 Number of patients
|
1 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any serious TE infection: through week 16
|
0 Number of patients
|
1 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any serious TE infection: through week 28
|
0 Number of patients
|
1 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any serious TE infection: through week 40
|
0 Number of patients
|
1 Number of patients
|
3 Number of patients
|
0 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Any serious TE infection: through week 52
|
0 Number of patients
|
1 Number of patients
|
3 Number of patients
|
0 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Infection requiring antibiotic treatment: week 12
|
13 Number of patients
|
5 Number of patients
|
12 Number of patients
|
2 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Infection requiring antibiotic treatment: week 16
|
19 Number of patients
|
6 Number of patients
|
15 Number of patients
|
2 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Infection requiring antibiotic treatment: week 28
|
23 Number of patients
|
10 Number of patients
|
22 Number of patients
|
6 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Infection requiring antibiotic treatment: week 40
|
25 Number of patients
|
12 Number of patients
|
31 Number of patients
|
7 Number of patients
|
|
Rate of Infections, Severe Infections and Infections Requiring Oral or Parenteral Antimicrobial Treatment During the Study Period
Infection requiring antibiotic treatment: week 52
|
27 Number of patients
|
13 Number of patients
|
32 Number of patients
|
8 Number of patients
|
SECONDARY outcome
Timeframe: at week 12, 16, 28 40 and 52Population: All randomized patients who took at least one dose of study medication and set who had any post-baseline safety information
The number of patients with a malignancy and other event of clinical interest (tuberculosis, serious cardiovascular events, anaphylactic/serum sickness reaction) were summarized through Week 12 and through Week 52, by treatment arm and body weight category (≤100 kg and \>100 kg)
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=195 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
n=196 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
n=49 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
TE anaphylactic/serum sickness reaction: week 40
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
TE anaphylactic/serum sickness reaction: week 52
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any treatment-emergent (TE) malignancy: week 12
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE malignancy: week 16
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE malignancy: week 28
|
0 Number of patients
|
0 Number of patients
|
2 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE malignancy: week 40
|
0 Number of patients
|
0 Number of patients
|
2 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE malignancy: week 52
|
2 Number of patients
|
0 Number of patients
|
2 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE tuberculosis: through week 12
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE tuberculosis: through week 16
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE tuberculosis: through week 28
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE tuberculosis: through week 40
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE tuberculosis: through week 52
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE serious cardiovascular event: week 12
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE serious cardiovascular event: week 16
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE serious cardiovascular event: week 28
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE serious cardiovascular event: week 40
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
Any TE serious cardiovascular event: week 52
|
0 Number of patients
|
0 Number of patients
|
1 Number of patients
|
1 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
TE anaphylactic/serum sickness reaction: week 12
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
TE anaphylactic/serum sickness reaction: week 16
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
|
Rate of Malignancies and Other Events of Clinical Interest (Tuberculosis, Serious Cardiovascular Events, Anaphylactic/Serum Sickness Reaction)
TE anaphylactic/serum sickness reaction: week 28
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
0 Number of patients
|
SECONDARY outcome
Timeframe: at Weeks 0, 2, 4, 12, 16, 28, 40 and 52Population: The modified intent-to-treat (mITT) analysis includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis
Change from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=243 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 40
|
-13.78 Units on a scale
Standard Deviation 7.65
|
-13.47 Units on a scale
Standard Deviation 6.61
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 2
|
-3.73 Units on a scale
Standard Deviation 4.69
|
-4.28 Units on a scale
Standard Deviation 4.37
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 4
|
-7.65 Units on a scale
Standard Deviation 5.93
|
-7.82 Units on a scale
Standard Deviation 5.42
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 12
|
-12.93 Units on a scale
Standard Deviation 7.35
|
-12.7 Units on a scale
Standard Deviation 6.6
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 16
|
-12.84 Units on a scale
Standard Deviation 7.44
|
-12.97 Units on a scale
Standard Deviation 7.11
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 28
|
-13.38 Units on a scale
Standard Deviation 7.8
|
-13.43 Units on a scale
Standard Deviation 7.47
|
—
|
—
|
|
Change in Mean Psoriasis Area-and-severity Index (PASI) Score Compared to Baseline
week 52
|
-13.84 Units on a scale
Standard Deviation 7.24
|
-13.98 Units on a scale
Standard Deviation 6.62
|
—
|
—
|
SECONDARY outcome
Timeframe: at Weeks 2, 4, 12, 16, 28, 40 and 52Population: The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
This is based on the number of participants achieving at least 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=243 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Proportion of Patients Achieving PASI 50 Response
week 28
|
84.9 Percentage of participants
Interval 80.3 to 89.5
|
87.7 Percentage of participants
Interval 83.5 to 91.9
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 2
|
10.3 Percentage of participants
Interval 6.5 to 14.1
|
15.6 Percentage of participants
Interval 11.1 to 20.2
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 4
|
39.3 Percentage of participants
Interval 33.1 to 45.4
|
49.2 Percentage of participants
Interval 42.9 to 55.5
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 12
|
83.8 Percentage of participants
Interval 79.2 to 88.5
|
86.1 Percentage of participants
Interval 81.7 to 90.5
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 16
|
83.5 Percentage of participants
Interval 78.7 to 88.2
|
84.2 Percentage of participants
Interval 79.5 to 88.8
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 40
|
90.7 Percentage of participants
Interval 86.9 to 94.5
|
88.5 Percentage of participants
Interval 84.3 to 92.7
|
—
|
—
|
|
Proportion of Patients Achieving PASI 50 Response
week 52
|
90.6 Percentage of participants
Interval 86.8 to 94.4
|
91.0 Percentage of participants
Interval 87.2 to 94.7
|
—
|
—
|
SECONDARY outcome
Timeframe: at Weeks 2, 4, 12, 16, 28, 40 and 52Population: The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
This is based on the number of participants achieving at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=243 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Proportion of Patients Achieving PASI 75 Response
week 2
|
2.9 Percentage of participants
Interval 0.8 to 5.0
|
2.5 Percentage of participants
Interval 0.5 to 4.4
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 4
|
12.0 Percentage of participants
Interval 7.9 to 16.1
|
15.3 Percentage of participants
Interval 10.8 to 19.8
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 12
|
58.1 Percentage of participants
Interval 51.9 to 64.3
|
62.2 Percentage of participants
Interval 56.0 to 68.3
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 16
|
63.6 Percentage of participants
Interval 57.4 to 69.7
|
64.6 Percentage of participants
Interval 58.5 to 70.6
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 28
|
71.1 Percentage of participants
Interval 65.3 to 77.0
|
71.1 Percentage of participants
Interval 65.3 to 76.9
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 40
|
76.9 Percentage of participants
Interval 71.4 to 82.4
|
72.1 Percentage of participants
Interval 66.3 to 78.0
|
—
|
—
|
|
Proportion of Patients Achieving PASI 75 Response
week 52
|
76.3 Percentage of participants
Interval 70.8 to 81.9
|
76.9 Percentage of participants
Interval 71.4 to 82.5
|
—
|
—
|
SECONDARY outcome
Timeframe: at Weeks 2, 4, 12, 16, 28, 40 and 52Population: The modified intent-to-treat (mITT) analysis set includes all subjects who were randomized and received at least one dose of ustekinumab, regardless of their compliance with the protocol. Subjects who dropped out after randomization and before the first administration of ustekinumab were excluded from the mITT analysis.
This is based on the number of participants achieving at least 90% improvement from baseline in Psoriasis Area and Severity Index (PASI) (0 \[best\] - 72 \[worst\]). The PASI is a test of how bad a person's psoriasis is. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score.
Outcome measures
| Measure |
UST / MTX Stopped: Patients <=100 kg
n=244 Participants
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Stopped: Patients >100kg
n=243 Participants
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients <=100 kg
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
UST / MTX Gradually Withdrawn: Patients >100kg
Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
|
|---|---|---|---|---|
|
Proportion of Patients Achieving PASI 90 Response
week 2
|
0.4 Percentage of participants
Interval 0.0 to 1.2
|
0.8 Percentage of participants
Interval 0.0 to 2.0
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 4
|
3.3 Percentage of participants
Interval 1.1 to 5.6
|
3.3 Percentage of participants
Interval 1.1 to 5.6
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 12
|
33.2 Percentage of participants
Interval 27.2 to 39.1
|
31.9 Percentage of participants
Interval 26.0 to 37.9
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 16
|
39.0 Percentage of participants
Interval 32.8 to 45.2
|
42.1 Percentage of participants
Interval 35.8 to 48.3
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 28
|
46.6 Percentage of participants
Interval 40.1 to 53.0
|
47.7 Percentage of participants
Interval 41.3 to 54.0
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 40
|
46.7 Percentage of participants
Interval 40.1 to 53.2
|
49.1 Percentage of participants
Interval 42.6 to 55.6
|
—
|
—
|
|
Proportion of Patients Achieving PASI 90 Response
week 52
|
47.8 Percentage of participants
Interval 41.2 to 54.3
|
49.3 Percentage of participants
Interval 42.7 to 55.9
|
—
|
—
|
Adverse Events
UST / MTX Stopped
Serious events: 20 serious events
Other events: 113 other events
Deaths: 0 deaths
UST / MTX Gradually Withdrawn
Serious events: 20 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UST / MTX Stopped
n=244 participants at risk
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn
n=245 participants at risk
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.82%
2/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Hepatitis B
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.82%
2/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.82%
2/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Psychiatric disorders
Alcoholism
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.2%
3/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Haemorrhage
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.41%
1/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Varicose vein
|
0.41%
1/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
0.00%
0/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
Other adverse events
| Measure |
UST / MTX Stopped
n=244 participants at risk
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
|
UST / MTX Gradually Withdrawn
n=245 participants at risk
Patients weighing \<=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing \>100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
20.1%
49/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
23.3%
57/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.2%
25/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
11.0%
27/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.7%
14/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
5.7%
14/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Nervous system disorders
Headache
|
13.5%
33/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
13.5%
33/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
8/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
6.9%
17/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.7%
9/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
8.2%
20/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
|
Vascular disorders
Hypertension
|
6.6%
16/244 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
7.8%
19/245 • From week 0 to week 52
Only subjects who had at least one of the TEAEs listed in the Other (non Serious) AE table are included in the Total no. subjects with Non-Serious Adverse Events.
|
Additional Information
EMEA THERAPEUTIC AREA LEADER
Janssen-Cilag France
Phone: +33 6 15167408
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the Sponsor for review at least 60 days prior to submission for publication or presentation. No paper that incorporates Confidential Information will be submitted for publication without Sponsor's prior written consent. If requested in writing, such publication will be withheld for up to an additional 60 calendar days. A publication from the individual Study site data will not be published until the combined results have been published.
- Publication restrictions are in place
Restriction type: OTHER