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A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01606761
Collaborator
GlaxoSmithKline (Industry)
878
Enrollment
205
Locations
3
Arms
41.2
Actual Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
878 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy
Actual Study Start Date :
Aug 6, 2012
Actual Primary Completion Date :
Mar 17, 2015
Actual Study Completion Date :
Jan 12, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Patients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52.

Drug: Placebo
Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.

Drug: Sirukumab
Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.
Experimental: Group 2

Patients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52.

Drug: Sirukumab
Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.
Experimental: Group 3

Patients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.

Drug: Placebo
Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.

Drug: Sirukumab
Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16 [Week 16]

    The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

Secondary Outcome Measures

  1. Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 [Baseline and Week 24]

    The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). 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.

  2. Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24 [Week 24]

    The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

  3. Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24 [Week 24]

    The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening

  • Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline

  • Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents

  • If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent

  • If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent

  • If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD

  • C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening

Exclusion Criteria:

  • Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration

  • Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration

  • Has received etanercept or yisaipu within 4 weeks of the first study agent administration

  • Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration

  • Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy

  • Has used anakinra within 1 week of first study agent administration

  • Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration

  • Has received intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration

  • Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable

  • Has a history of cyclophosphamide or cytotoxic agent use

  • Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration

  • Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States
2 Glendale Arizona United States
3 Mesa Arizona United States
4 Phoenix Arizona United States
5 Covina California United States
6 El Cajon California United States
7 Hemet California United States
8 Huntington Beach California United States
9 La Jolla California United States
10 La Palma California United States
11 Placentia California United States
12 Santa Monica California United States
13 Tustin California United States
14 Upland California United States
15 Victorville California United States
16 Whittier California United States
17 Hamden Connecticut United States
18 Aventura Florida United States
19 Boca Raton Florida United States
20 Brandon Florida United States
21 Daytona Beach Florida United States
22 Lake Mary Florida United States
23 Miami Florida United States
24 Naples Florida United States
25 Orlando Florida United States
26 Palm Harbor Florida United States
27 Plantation Florida United States
28 Sarasota Florida United States
29 Tampa Florida United States
30 Zephyrhills Florida United States
31 Boise Idaho United States
32 Idaho Falls Idaho United States
33 Indianapolis Indiana United States
34 Cedar Rapids Iowa United States
35 Bowling Green Kentucky United States
36 Monroe Louisiana United States
37 Shreveport Louisiana United States
38 Cumberland Maryland United States
39 Frederick Maryland United States
40 Hagerstown Maryland United States
41 Eagan Minnesota United States
42 Rochester Minnesota United States
43 Flowood Mississippi United States
44 Tupelo Mississippi United States
45 Saint Louis Missouri United States
46 Springfield Missouri United States
47 Omaha Nebraska United States
48 Las Vegas Nevada United States
49 Freehold New Jersey United States
50 Albuquerque New Mexico United States
51 Brooklyn New York United States
52 Lake Success New York United States
53 Plainview New York United States
54 Charlotte North Carolina United States
55 Hickory North Carolina United States
56 Cincinnati Ohio United States
57 Columbus Ohio United States
58 Dayton Ohio United States
59 Middleburg Heights Ohio United States
60 Edmond Oklahoma United States
61 Tulsa Oklahoma United States
62 Erie Pennsylvania United States
63 Pittsburgh Pennsylvania United States
64 Wyomissing Pennsylvania United States
65 East Greenwich Rhode Island United States
66 Charleston South Carolina United States
67 Austin Texas United States
68 Carrollton Texas United States
69 Corpus Christi Texas United States
70 Cypress Texas United States
71 Dallas Texas United States
72 Houston Texas United States
73 Katy Texas United States
74 Lubbock Texas United States
75 Mesquite Texas United States
76 Richmond Texas United States
77 Victoria Texas United States
78 Kennewick Washington United States
79 Seattle Washington United States
80 Beckley West Virginia United States
81 Clarksburg West Virginia United States
82 Ciudad Autónoma De Buenos Aires Argentina
83 Rosario Argentina
84 San Miguel De Tucuman Argentina
85 Campbelltown Australia
86 Victoria Park Australia
87 Vienna Austria
88 Wien Austria
89 Liège Belgium
90 Victoria British Columbia Canada
91 Winnipeg Manitoba Canada
92 St. John'S Newfoundland and Labrador Canada
93 Kitchener Ontario Canada
94 Burlington Canada
95 Saint-John'S Canada
96 Toronto N/A Canada
97 Zagreb Croatia
98 Paris France
99 Toulouse Cedex 9 France
100 Berlin Germany
101 Dresden Germany
102 Erfurt Germany
103 Frankfurt/Main Germany
104 Gÿttingen N/A Germany
105 Hamburg Germany
106 Herne Germany
107 Kiel Kronshagen Germany
108 Köln Germany
109 Schwerin Germany
110 Vogelsang-Gommern Germany
111 Würzburg Germany
112 Zerbst Germany
113 Ayauta Japan
114 Bunkyo-Ku Japan
115 Fukuoka Japan
116 Fukuyama Japan
117 Higashihiroshima Japan
118 Hiroshima Japan
119 Izumo Japan
120 Kagoshima Japan
121 Kato Japan
122 Kawagoe Japan
123 Kita-Gun Japan
124 Kumamoto Japan
125 Kurume Japan
126 Matsuyama Japan
127 Miyazaki Japan
128 Nagano Japan
129 Nagasaki Japan
130 Nagoya Japan
131 Nishimuro-Gun Japan
132 Nishinomiya Japan
133 Okayama Japan
134 Osaka Japan
135 Sapporo Japan
136 Sasebo Japan
137 Shibata Japan
138 Shimonoseki Japan
139 Shimotsuke Japan
140 Shinjuku-Ku Japan
141 Sumida-Ku Japan
142 Takaoka,Toyama Japan
143 Takasaki Japan
144 Tokorozawa Japan
145 Tokushima Japan
146 Tomakomai Japan
147 Tomishiro Japan
148 Tonami Japan
149 Tsu Japan
150 Ureshino Japan
151 Yokohama Japan
152 Busan Korea, Republic of
153 Daegu Korea, Republic of
154 Daejeon Korea, Republic of
155 Gwangju Korea, Republic of
156 Incheon Korea, Republic of
157 Jeonju-Si Korea, Republic of
158 Seongnam-Si Korea, Republic of
159 Seoul Korea, Republic of
160 Suwon Korea, Republic of
161 Kaunas Lithuania
162 Klaipeda Lithuania
163 Guadalajara Mexico
164 Merida Mexico
165 San Luis Potosí Mexico
166 Sneek Netherlands
167 Christchurch New Zealand
168 Hamilton New Zealand
169 Wellington New Zealand
170 Bydgoszcz Poland
171 Elblag Poland
172 Lublin Poland
173 Poznan Poland
174 Ustron Poland
175 Warszawa Poland
176 Coimbra Portugal
177 Lisboa Portugal
178 Lisbon Portugal
179 San Juan Puerto Rico
180 Barnaul Russian Federation
181 Moscow N/A Russian Federation
182 Moscow Russian Federation
183 Novosibirsk Russian Federation
184 Omsk Russian Federation
185 Orenburg Russian Federation
186 Ryazan Russian Federation
187 Saint Petersburg Russian Federation
188 Saratov Russian Federation
189 Ulyanovsk Russian Federation
190 Bilbao Spain
191 Coruña Spain
192 La Laguna Spain
193 Madrid Spain
194 Mérida Spain
195 Santander Spain
196 Santiago De Compostela Spain
197 Kaohsiung Taiwan
198 Taichung City Taiwan
199 Taichung Taiwan
200 Taipei Taiwan
201 Barnsley United Kingdom
202 London United Kingdom
203 Middlesbrough United Kingdom
204 Sheffield United Kingdom
205 Wigan United Kingdom

Sponsors and Collaborators

  • Janssen Research & Development, LLC
  • GlaxoSmithKline

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01606761
Other Study ID Numbers:
  • CR100864
  • CNTO136ARA3003
  • 2010-022243-38
  • U1111-1135-6365
First Posted:
May 28, 2012
Last Update Posted:
Mar 23, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Janssen Research & Development, LLC
Arthritis, Rheumatoid
Active rheumatoid arthritis despite anti-TNF-alpha therapy
Sirukumab
Human Anti-IL-6 monoclonal antibody
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail A total of 878 participants (placebo [n=294], sirukumab 50 mg every 4 week (q4w) [n=292], and sirukumab 100 milligram (mg) every 2 week (q2w) [n=292]) were randomized and included in the study.
Arm/Group Title Placebo Sirukumab 50 mg q4w Sirukumab 100 mg q2w Placebo to 50 mg q4w Due to EE or CO Placebo to 100 mg q2w Due to EE or CO
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety. All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
Period Title: Prior to Week 24
STARTED 294 292 292 0 0
Participants Re-randomized at Week 18 94 0 0 0 0
COMPLETED 252 237 245 0 0
NOT COMPLETED 42 55 47 0 0
Period Title: Prior to Week 24
STARTED 0 237 245 126 126
Treated 0 237 245 124 126
COMPLETED 0 204 212 109 106
NOT COMPLETED 0 33 33 17 20
Period Title: Prior to Week 24
STARTED 28 65 62 9 19
Safety Population 28 65 62 7 19
COMPLETED 24 55 45 7 11
NOT COMPLETED 4 10 17 2 8

Baseline Characteristics

Arm/Group Title Placebo Sirukumab 50 mg q4w Sirukumab 100 mg q2w Total
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety. All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Total of all reporting groups
Overall Participants 294 292 292 878
Age (Count of Participants)
<=18 years
0
(12.19) 0%
0
(11.89) 0%
0
(12.28) 0%
0
0%
Between 18 and 65 years
228
77.6%
225
77.1%
230
78.8%
683
77.8%
>=65 years
66
22.4%
67
22.9%
62
21.2%
195
22.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
55.4
(12.19)
55.8
(11.89)
55
(12.28)
55.4
(12.11)
Sex: Female, Male (Count of Participants)
Female
240
81.6%
232
79.5%
240
82.2%
712
81.1%
Male
54
18.4%
60
20.5%
52
17.8%
166
18.9%
Region of Enrollment (Count of Participants)
Argentina
10
3.4%
6
2.1%
3
1%
19
2.2%
Australia
1
0.3%
2
0.7%
0
0%
3
0.3%
Austria
2
0.7%
0
0%
0
0%
2
0.2%
Belgium
1
0.3%
0
0%
0
0%
1
0.1%
Canada
2
0.7%
7
2.4%
1
0.3%
10
1.1%
France
0
0%
1
0.3%
0
0%
1
0.1%
Germany
7
2.4%
13
4.5%
7
2.4%
27
3.1%
Italy
5
1.7%
0
0%
4
1.4%
9
1%
Japan
37
12.6%
35
12%
44
15.1%
116
13.2%
Lithuania
4
1.4%
7
2.4%
5
1.7%
16
1.8%
Mexico
7
2.4%
4
1.4%
6
2.1%
17
1.9%
Netherlands
4
1.4%
1
0.3%
1
0.3%
6
0.7%
Poland
21
7.1%
29
9.9%
26
8.9%
76
8.7%
Portugal
3
1%
4
1.4%
4
1.4%
11
1.3%
Puerto Rico
1
0.3%
6
2.1%
1
0.3%
8
0.9%
Republic of Korea
5
1.7%
7
2.4%
5
1.7%
17
1.9%
Russian Federation
18
6.1%
11
3.8%
21
7.2%
50
5.7%
Spain
8
2.7%
8
2.7%
7
2.4%
23
2.6%
Taiwan, Province of China
8
2.7%
2
0.7%
2
0.7%
12
1.4%
United Kingdom
2
0.7%
4
1.4%
3
1%
9
1%
United States
148
50.3%
145
49.7%
152
52.1%
445
50.7%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16
Description The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame Week 16

Outcome Measure Data

Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Measure Participants 294 292 292
Number [Percentage of Participants]
24.1
8.2%
40.1
13.7%
45.2
15.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 15.9
Confidence Interval (2-Sided) 95%
8.5 to 23.2
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 21.0
Confidence Interval (2-Sided) 95%
13.6 to 28.5
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24
Description The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). 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.
Time Frame Baseline and Week 24

Outcome Measure Data

Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Measure Participants 294 291 292
Baseline
1.5663
(0.65223)
1.6499
(0.59743)
1.6122
(0.61320)
Change at Week 24
-0.12
(0.491)
-0.31
(0.543)
-0.33
(0.526)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Least Square (LS) mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.251 to -0.088
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.194
Confidence Interval (2-Sided) 95%
-0.275 to -0.112
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24
Description The ACR 50 Response is defined as >= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 =no pain to 10 =worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).
Time Frame Week 24

Outcome Measure Data

Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Measure Participants 294 292 292
Number [Percentage of Participants]
8.8
3%
20.9
7.2%
21.6
7.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.0
Confidence Interval (2-Sided) 95%
6.4 to 17.7
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
7.0 to 18.4
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24
Description The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (<) 2.6 at any study visit.
Time Frame Week 24

Outcome Measure Data

Analysis Population Description
Efficacy full analysis set included all participants who were randomized into the study.
Arm/Group Title Placebo Sirukumab 50 mg Sirukumab 100 mg
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.
Measure Participants 294 292 292
Number [Percentage of Participants]
8.2
2.8%
19.2
6.6%
21.6
7.4%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 50 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 11.0
Confidence Interval (2-Sided) 95%
5.5 to 16.5
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Sirukumab 100 mg
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value < 0.001
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 13.4
Confidence Interval (2-Sided) 95%
7.8 to 19.1
Parameter Dispersion Type:
Value:
Estimation Comments

Adverse Events

Time Frame Up to Week 68
Adverse Event Reporting Description For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).
Arm/Group Title Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Arm/Group Description Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24. Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52. Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape [EE] at Week 18 or crossed over [CO] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52. Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68. Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.
All Cause Mortality
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 15/294 (5.1%) 8/124 (6.5%) 51/292 (17.5%) 18/126 (14.3%) 37/292 (12.7%) 0/28 (0%) 0/7 (0%) 1/65 (1.5%) 2/19 (10.5%) 0/62 (0%)
Blood and lymphatic system disorders
Anaemia 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Normochromic Normocytic Anaemia 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pancytopenia 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Thrombocytopenia 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Cardiac disorders
Acute Coronary Syndrome 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Angina Unstable 0/294 (0%) 0/124 (0%) 3/292 (1%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Atrial Fibrillation 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Atrial Flutter 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Coronary Artery Disease 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Coronary Artery Stenosis 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Myocardial Infarction 1/294 (0.3%) 0/124 (0%) 1/292 (0.3%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Endocrine disorders
Goitre 0/294 (0%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Eye disorders
Diplopia 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastrointestinal disorders
Anal Fissure 0/294 (0%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Diverticular Perforation 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Diverticulum Intestinal 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Duodenal Ulcer 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Duodenal Ulcer Perforation 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Faecal Incontinence 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastric Ulcer 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastric Ulcer Perforation 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastritis Erosive 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastrooesophageal Reflux Disease 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Intestinal Obstruction 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Large Intestine Polyp 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Lower Gastrointestinal Haemorrhage 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pancreatic Pseudocyst 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pancreatitis Acute 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Tongue Ulceration 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
General disorders
Chest Pain 1/294 (0.3%) 1/124 (0.8%) 1/292 (0.3%) 0/126 (0%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Device Dislocation 0/294 (0%) 0/124 (0%) 2/292 (0.7%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Impaired Healing 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Non-Cardiac Chest Pain 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Sudden Death 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Hepatobiliary disorders
Cholecystitis Acute 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Cholelithiasis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Immune system disorders
Drug Hypersensitivity 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Food Allergy 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Infections and infestations
Abdominal Abscess 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Abscess Jaw 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Alpha Haemolytic Streptococcal Infection 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Appendicitis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Arthritis Infective 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Bacteraemia 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Cellulitis 0/294 (0%) 0/124 (0%) 3/292 (1%) 2/126 (1.6%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Clostridium Difficile Colitis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Colonic Abscess 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Cystitis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Device Related Infection 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Diverticulitis 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Empyema 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Erysipelas 0/294 (0%) 0/124 (0%) 0/292 (0%) 2/126 (1.6%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Escherichia Sepsis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Gastroenteritis 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Herpes Zoster 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Infectious Pleural Effusion 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Influenza 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Necrotising Fasciitis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Osteomyelitis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Peritonitis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pneumonia 1/294 (0.3%) 0/124 (0%) 5/292 (1.7%) 0/126 (0%) 5/292 (1.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Sepsis 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Urinary Tract Infection 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Urosepsis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Wound Infection Pseudomonas 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Injury, poisoning and procedural complications
Femur Fracture 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Periprosthetic Fracture 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Tendon Rupture 0/294 (0%) 0/124 (0%) 2/292 (0.7%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Investigations
Aspartate Aminotransferase Increased 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Hepatic Enzyme Abnormal 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Hepatic Enzyme Increased 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Liver Function Test Abnormal 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Morganella Test Positive 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Metabolism and nutrition disorders
Hypoglycaemia 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Hypokalaemia 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Arthropathy 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Back Pain 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Foot Deformity 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 2/292 (0.7%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Haemarthrosis 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Intervertebral Disc Protrusion 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Musculoskeletal Chest Pain 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Osteoarthritis 0/294 (0%) 1/124 (0.8%) 3/292 (1%) 1/126 (0.8%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Osteochondrosis 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Osteonecrosis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Rheumatoid Arthritis 2/294 (0.7%) 2/124 (1.6%) 3/292 (1%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 1/65 (1.5%) 0/19 (0%) 0/62 (0%)
Soft Tissue Necrosis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Spondylolisthesis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Chondroma 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Invasive Ductal Breast Carcinoma 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Lung Adenocarcinoma 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Lymphoproliferative Disorder 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Oropharyngeal Squamous Cell Carcinoma 0/294 (0%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Rectal Adenocarcinoma 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Nervous system disorders
Carotid Artery Stenosis 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Cerebrovascular Accident 0/294 (0%) 1/124 (0.8%) 2/292 (0.7%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Diabetic Neuropathy 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Lumbar Radiculopathy 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Transient Ischaemic Attack 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion Missed 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Psychiatric disorders
Anxiety 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Mental Status Changes 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Renal and urinary disorders
Acute Kidney Injury 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Calculus Ureteric 1/294 (0.3%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Calculus Urinary 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Nephrolithiasis 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Nephrotic Syndrome 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Renal Colic 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Reproductive system and breast disorders
Cervical Dysplasia 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Interstitial Lung Disease 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Laryngeal Oedema 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Oropharyngeal Discomfort 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pleural Effusion 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pulmonary Embolism 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Skin and subcutaneous tissue disorders
Dermatitis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Drug Eruption 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Skin Ulcer 1/294 (0.3%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Vascular disorders
Hypertension 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Intermittent Claudication 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Phlebitis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Thrombosed Varicose Vein 0/294 (0%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Other (Not Including Serious) Adverse Events
Week (W) 24-Placebo W24 to W52-Placebo to 50 mg q4w Due to EE or CO W52-Sirukumab 50 mg q4w W24 to W52-Placebo to 100 mg q2w Due to EE or CO W52-Sirukumab 100 mg q2w W52 to W68-Placebo W52 to W68-Placebo to 50 mg q4w Due to EE or CO W52 to W68-Sirukumab 50 mg q4w W52 to W68-Placebo to 100 mg q2w Due to EE or CO W52 to W68-Sirukumab 100 mg q2w
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 106/294 (36.1%) 50/124 (40.3%) 152/292 (52.1%) 63/126 (50%) 169/292 (57.9%) 0/28 (0%) 1/7 (14.3%) 2/65 (3.1%) 3/19 (15.8%) 4/62 (6.5%)
Eye disorders
Blepharitis 1/294 (0.3%) 1/124 (0.8%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Gastrointestinal disorders
Chronic Gastritis 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Nausea 4/294 (1.4%) 2/124 (1.6%) 10/292 (3.4%) 1/126 (0.8%) 13/292 (4.5%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
General disorders
Injection Site Erythema 4/294 (1.4%) 5/124 (4%) 28/292 (9.6%) 19/126 (15.1%) 47/292 (16.1%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Injection Site Pruritus 2/294 (0.7%) 4/124 (3.2%) 8/292 (2.7%) 10/126 (7.9%) 31/292 (10.6%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Injection Site Swelling 0/294 (0%) 2/124 (1.6%) 4/292 (1.4%) 7/126 (5.6%) 24/292 (8.2%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Hepatobiliary disorders
Drug-Induced Liver Injury 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Infections and infestations
Bronchitis 5/294 (1.7%) 7/124 (5.6%) 13/292 (4.5%) 4/126 (3.2%) 22/292 (7.5%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Conjunctivitis Bacterial 0/294 (0%) 0/124 (0%) 0/292 (0%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Nasopharyngitis 11/294 (3.7%) 2/124 (1.6%) 34/292 (11.6%) 7/126 (5.6%) 26/292 (8.9%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Pneumonia 0/294 (0%) 1/124 (0.8%) 3/292 (1%) 2/126 (1.6%) 5/292 (1.7%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Sinusitis 8/294 (2.7%) 5/124 (4%) 14/292 (4.8%) 3/126 (2.4%) 15/292 (5.1%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Upper Respiratory Tract Infection 19/294 (6.5%) 6/124 (4.8%) 24/292 (8.2%) 9/126 (7.1%) 26/292 (8.9%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Urinary Tract Infection 11/294 (3.7%) 2/124 (1.6%) 13/292 (4.5%) 6/126 (4.8%) 19/292 (6.5%) 0/28 (0%) 0/7 (0%) 1/65 (1.5%) 0/19 (0%) 0/62 (0%)
Investigations
Alanine Aminotransferase Increased 6/294 (2%) 12/124 (9.7%) 27/292 (9.2%) 8/126 (6.3%) 23/292 (7.9%) 0/28 (0%) 0/7 (0%) 1/65 (1.5%) 1/19 (5.3%) 1/62 (1.6%)
Aspartate Aminotransferase Increased 4/294 (1.4%) 6/124 (4.8%) 18/292 (6.2%) 5/126 (4%) 15/292 (5.1%) 0/28 (0%) 0/7 (0%) 1/65 (1.5%) 1/19 (5.3%) 1/62 (1.6%)
Hepatitis B Dna Assay Positive 0/294 (0%) 0/124 (0%) 1/292 (0.3%) 1/126 (0.8%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Lymphocyte Count Increased 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Neutrophil Count Increased 2/294 (0.7%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
White Blood Cell Count Increased 2/294 (0.7%) 1/124 (0.8%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
X-Ray with Contrast Upper Gastrointestinal Tract Abnormal 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Metabolism and nutrition disorders
Hyperglycaemia 3/294 (1%) 2/124 (1.6%) 3/292 (1%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Musculoskeletal and connective tissue disorders
Back Pain 2/294 (0.7%) 0/124 (0%) 7/292 (2.4%) 1/126 (0.8%) 9/292 (3.1%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Muscle Spasms 2/294 (0.7%) 2/124 (1.6%) 5/292 (1.7%) 1/126 (0.8%) 7/292 (2.4%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 1/62 (1.6%)
Rheumatoid Arthritis 28/294 (9.5%) 13/124 (10.5%) 30/292 (10.3%) 4/126 (3.2%) 30/292 (10.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 1/62 (1.6%)
Respiratory, thoracic and mediastinal disorders
Cough 2/294 (0.7%) 4/124 (3.2%) 13/292 (4.5%) 4/126 (3.2%) 22/292 (7.5%) 0/28 (0%) 1/7 (14.3%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Nasal Pruritus 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 0/292 (0%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Skin and subcutaneous tissue disorders
Eczema Asteatotic 0/294 (0%) 0/124 (0%) 0/292 (0%) 0/126 (0%) 1/292 (0.3%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 1/19 (5.3%) 0/62 (0%)
Rash 3/294 (1%) 2/124 (1.6%) 9/292 (3.1%) 0/126 (0%) 15/292 (5.1%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 0/62 (0%)
Vascular disorders
Hypertension 7/294 (2.4%) 3/124 (2.4%) 17/292 (5.8%) 3/126 (2.4%) 15/292 (5.1%) 0/28 (0%) 0/7 (0%) 0/65 (0%) 0/19 (0%) 1/62 (1.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring 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 in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

Name/Title Associate Director
Organization Janssen Research & Development, LLC
Phone
Email ClinicalTrialDisclosure@its.jnj.com
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01606761
Other Study ID Numbers:
  • CR100864
  • CNTO136ARA3003
  • 2010-022243-38
  • U1111-1135-6365
First Posted:
May 28, 2012
Last Update Posted:
Mar 23, 2018
Last Verified:
Feb 1, 2018