Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy (NCT NCT01645280)
NCT ID: NCT01645280
Last Updated: 2016-05-12
Results Overview
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
274 participants
Primary outcome timeframe
Week 28
Results posted on
2016-05-12
Participant Flow
A total of 274 subjects were enrolled into the study and 273 were treated. One participant in the Ustekinumab 90 milligram (mg) every 8 weeks group did not receive the treatment due to an adverse event before dosing.
Participant milestones
| Measure |
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
54
|
55
|
54
|
55
|
|
Overall Study
COMPLETED
|
49
|
51
|
49
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
6
|
6
|
8
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
2
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Other
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Treatment not completed/Completed f/u
|
1
|
1
|
2
|
0
|
2
|
Baseline Characteristics
A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Placebo
n=55 Participants
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Total
n=274 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.1 years
STANDARD_DEVIATION 10.57 • n=99 Participants
|
50.8 years
STANDARD_DEVIATION 13.01 • n=107 Participants
|
51.4 years
STANDARD_DEVIATION 13.59 • n=206 Participants
|
54.6 years
STANDARD_DEVIATION 11.34 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 12.85 • n=31 Participants
|
51.5 years
STANDARD_DEVIATION 12.34 • n=30 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
228 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
46 Participants
n=30 Participants
|
|
Region of Enrollment
Argentina
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
6 participants
n=206 Participants
|
5 participants
n=7 Participants
|
6 participants
n=31 Participants
|
23 participants
n=30 Participants
|
|
Region of Enrollment
Bulgaria
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
1 participants
n=31 Participants
|
9 participants
n=30 Participants
|
|
Region of Enrollment
CZ Rep
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
2 participants
n=31 Participants
|
6 participants
n=30 Participants
|
|
Region of Enrollment
Colombia
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
8 participants
n=206 Participants
|
6 participants
n=7 Participants
|
10 participants
n=31 Participants
|
43 participants
n=30 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=99 Participants
|
5 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
3 participants
n=31 Participants
|
20 participants
n=30 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
6 participants
n=206 Participants
|
7 participants
n=7 Participants
|
9 participants
n=31 Participants
|
35 participants
n=30 Participants
|
|
Region of Enrollment
Russia
|
20 participants
n=99 Participants
|
15 participants
n=107 Participants
|
18 participants
n=206 Participants
|
19 participants
n=7 Participants
|
14 participants
n=31 Participants
|
86 participants
n=30 Participants
|
|
Region of Enrollment
Singapore
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
0 participants
n=31 Participants
|
4 participants
n=30 Participants
|
|
Region of Enrollment
USA
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
1 participants
n=30 Participants
|
|
Region of Enrollment
Ukraine
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
10 participants
n=206 Participants
|
8 participants
n=7 Participants
|
10 participants
n=31 Participants
|
46 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28
|
40.0 percentage of participants
|
52.7 percentage of participants
|
54.5 percentage of participants
|
44.4 percentage of participants
|
38.2 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 28Population: The modified-ITT population included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
|
-0.94 units on scale
Standard Error 0.174
|
-1.52 units on scale
Standard Error 0.185
|
-1.49 units on scale
Standard Error 0.183
|
-1.21 units on scale
Standard Error 0.170
|
6.07 units on scale
Standard Error 0.821
|
SECONDARY outcome
Timeframe: Week 12Population: The m-ITT population included participants who received at least 1 (partial or complete) dose of study agent.
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient's Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
|
29.1 percentage of participants
|
37.0 percentage of participants
|
34.5 percentage of participants
|
33.3 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 28Population: The m-ITT included participants who received at least 1 (partial or complete) dose of study agent. For early escape, data at or prior to Week 16 were carried forward through Week 28.
The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Placebo
n=55 Participants
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Ustekinumab 90 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 Participants
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 Participants
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 Participants
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
|
-0.30 units on scale
Standard Error 0.074
|
-0.48 units on scale
Standard Error 0.072
|
-0.44 units on scale
Standard Error 0.071
|
-0.41 units on scale
Standard Error 0.075
|
-0.39 units on scale
Standard Error 0.076
|
Adverse Events
Placebo
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo (Early Escape)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Ustekinumab 90 mg Every 8 Weeks
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Ustekinumab 90 mg Every 12 Weeks
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
CNTO1959 200 mg Every 8 Weeks
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
CNTO1959 50 mg Every 8 Weeks
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=55 participants at risk
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Placebo (Early Escape)
n=16 participants at risk
Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
|
Ustekinumab 90 mg Every 8 Weeks
n=54 participants at risk
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 participants at risk
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 participants at risk
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 participants at risk
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina Unstable
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage I
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Lung
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo
n=55 participants at risk
Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
|
Placebo (Early Escape)
n=16 participants at risk
Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
|
Ustekinumab 90 mg Every 8 Weeks
n=54 participants at risk
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
Ustekinumab 90 mg Every 12 Weeks
n=55 participants at risk
Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
|
CNTO1959 200 mg Every 8 Weeks
n=54 participants at risk
Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
CNTO1959 50 mg Every 8 Weeks
n=55 participants at risk
Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Influenza
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.6%
3/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
9.3%
5/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
7.3%
4/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
7.4%
4/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
9.1%
5/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
7.4%
4/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
9.1%
5/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.6%
3/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
7.4%
4/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.6%
3/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
7.4%
4/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.6%
2/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
5.5%
3/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
3.7%
2/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.9%
1/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate Aminotransferase Increased
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
1.8%
1/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/54 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/55 • Week 0 to 48
Safety population included all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER