A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Sponsor
Centocor, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00718718
Collaborator
(none)
187
38
7
30.7
4.9
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study) study. This study will be conducted in 2 parts (Part A and Part B). Each part consists of 3 phases: screening (approximately 1 month prior to the start of study medication), treatment phase (Part A: 22 weeks and Part B: 24 weeks), and follow-up phase (approximately 4 months after the last administration of study medication). In Part A, participants will be randomly assigned to 2 groups to receive CNTO 136 100 mg and placebo for 22 weeks. All participants in Part A, will be crossed over at Week 12 from placebo to CNTO 136 (for Group 1) and from CNTO 136 to placebo (for Group 2). In Part B, participants will be randomly assigned to 5 groups to receive placebo and/or 1 of 3 doses of CNTO 136 (100mg, 50mg or 25mg) for 24 weeks. Participants in Part B, Group 1 will be crossed over at Week 12 from placebo to CNTO 136. All participants should be maintained on a stable dose of MTX for at least 6 weeks prior to the start of study medication through Week 24. Safety will be evaluated by the assessment of adverse events, vital signs, clinical findings, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for a participant will be approximately 42 weeks.
Study Design
Study Type:
Interventional
Actual Enrollment
:
187 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, 2-Part, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Proof-of-concept, Dose-finding Study Evaluating the Efficacy and Safety of CNTO 136 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Actual Study Start Date
:
Aug 11, 2008
Actual Primary Completion Date
:
Mar 3, 2011
Actual Study Completion Date
:
Mar 3, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A, Group 1 Participants will receive placebo (Week 0 to Week 10) and later CNTO 136 100 mg (Week 12 to Week 22) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part A, Group 2 Participants will receive CNTO 136 100 mg (Week 0 to Week 10) and later placebo (Week 12 to Week 22) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part B, Group 1 Participants will receive placebo (Week 0 to Week 10) and later CNTO 136 100 mg (Week 12 to Week 24) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part B, Group 2 Participants will receive CNTO 136 100 mg (Week 0 to Week 24) every 2 weeks. Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Other Names:
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part B, Group 3 Participants will receive CNTO 136 100 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6, 10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 100 mg
CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part B, Group 4 Participants will receive CNTO 136 50 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6,10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 50 mg
CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
| Experimental: Part B, Group 5 Participants will receive CNTO 136 25 mg (Week 0 to Week 24) every 4 weeks and placebo at interim visits (Weeks 2, 6,10, 14, 18, and 22). Stable dose of methotrexate will be maintained through Week 24. |
Drug: CNTO 136 25 mg
CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.
Other Names:
Drug: Placebo
Placebo will be adminstered subcutaneously as per the appropriate randomized arm.
Drug: Methotrexate
Stable dose of methotrexate will be maintained through Week 24.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) [Week 12]
An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale 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
- Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) [Baseline, Week 12]
The 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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline.
- Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) [Week 12]
An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP.
- Serum Sirukumab Concentrations Through Week 38 (Part A) [Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38]
Sirukumab Concentrations in serum were measured.
- Serum Sirukumab Concentrations Through Week 38 (Part B) [Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38]
Sirukumab Concentrations in serum were measured.
- Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) [Baseline, Week 2]
Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with rheumatoid arthritis (RA) for at least 4 months prior to screening
-
Have been treated and having an inadequate response with the tolerated dose of methotrexate (MTX) (at least 15mg/week) for at least 4 months prior to screening. MTX doses of 10 or 12.5 mg/week are allowed if participant had intolerance of 15 mg/week
-
MTX route of administration and dose (not to exceed 25 mg/week) should be stable for at least 6 weeks prior to the start of the study medication
-
Have active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and baseline, and either anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive at screening
-
C-reactive protein greater than or equal to 1.0 mg/dL (10 mg/L)
-
Agree to use one of the contraception methods defined in the protocol
Exclusion Criteria:
-
Have inflammatory diseases other than RA that might confound the evaluation of the benefit of CNTO 136 therapy in arthritis
-
Family history of/ have long QT syndrome; or a history of second or third-degree heart block
-
Received systemic immunosuppressives or disease modifying antirheumatic drug other than MTX, sulfasalazine, hydroxychloroquine or chloroquine within 4 weeks prior to the start of study medication
-
Received intra articular (into joints), intramuscular, or intravenous corticosteroids within 4 weeks prior to the start of study medication
-
Positive human immunodeficiency virus test, hepatitis B or hepatitis C
-
History of / have chronic or recurrent infectious disease, history of / active tuberculosis
-
Have serious infection within 2 months prior to start of study medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aventura | Florida | United States | ||
| 2 | Lexington | Kentucky | United States | ||
| 3 | Frederick | Maryland | United States | ||
| 4 | Kalamazoo | Michigan | United States | ||
| 5 | Charlotte | North Carolina | United States | ||
| 6 | Winston-Salem | North Carolina | United States | ||
| 7 | Duncansville | Pennsylvania | United States | ||
| 8 | Anderson | South Carolina | United States | ||
| 9 | Budapest | Hungary | |||
| 10 | Győr | Hungary | |||
| 11 | Kecskemét | Hungary | |||
| 12 | Goshogawara | Japan | |||
| 13 | Hitachi | Japan | |||
| 14 | Kawagoe | Japan | |||
| 15 | Kitakyushu | Japan | |||
| 16 | Miyazaki | Japan | |||
| 17 | Sasebo | Japan | |||
| 18 | Shinjuku-Ku | Japan | |||
| 19 | Tomigusuku | Japan | |||
| 20 | Busan | Korea, Republic of | |||
| 21 | Dae-Gu | Korea, Republic of | |||
| 22 | Daejeon | Korea, Republic of | |||
| 23 | Seoul | Korea, Republic of | |||
| 24 | Ciudad De Mexico | Mexico | |||
| 25 | Guadalajara | Mexico | |||
| 26 | Mexico | Mexico | |||
| 27 | Bialystok | Poland | |||
| 28 | Bydgoszcz N/A | Poland | |||
| 29 | Elblag | Poland | |||
| 30 | Gdynia | Poland | |||
| 31 | Krakow | Poland | |||
| 32 | Lublin | Poland | |||
| 33 | Poznan | Poland | |||
| 34 | Warszawa | Poland | |||
| 35 | Kemerovo | Russian Federation | |||
| 36 | Moscow | Russian Federation | |||
| 37 | Novosibirsk | Russian Federation | |||
| 38 | St Petersburg | Russian Federation |
Sponsors and Collaborators
- Centocor, Inc.
Investigators
- Study Director: Centocor Clinical Trial, Centocor, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00718718
Other Study ID Numbers:
- CR015214
- C1377T04
- 2007-006603-20
First Posted:
Jul 21, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Dec 1, 2017
Studies a U.S. FDA-regulated Drug Product:
Yes
Keywords provided by Centocor, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Part A - Placebo (Wk 0-Wk 12) | Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Part A - Sirukumab (Wk 0-Wk 12) | Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Part B - Placebo (Wk 0-Wk 12) | Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Part B - Sirukumab 100mg q2w | Part B - Sirukumab 100mg q4w | Part B - Sirukumab 50mg q4w | Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. | Participants received placebo at Weeks 12 and q2w through Week 22. | Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks. | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. |
| Period Title: Prior to Week 12 | ||||||||||
| STARTED | 19 | 0 | 17 | 0 | 30 | 0 | 30 | 30 | 30 | 31 |
| COMPLETED | 18 | 0 | 16 | 0 | 27 | 0 | 29 | 28 | 28 | 31 |
| NOT COMPLETED | 1 | 0 | 1 | 0 | 3 | 0 | 1 | 2 | 2 | 0 |
| Period Title: Prior to Week 12 | ||||||||||
| STARTED | 0 | 18 | 0 | 16 | 0 | 27 | 29 | 28 | 28 | 31 |
| Treated | 0 | 18 | 0 | 16 | 0 | 26 | 29 | 28 | 28 | 31 |
| COMPLETED | 0 | 17 | 0 | 15 | 0 | 24 | 27 | 27 | 27 | 31 |
| NOT COMPLETED | 0 | 1 | 0 | 1 | 0 | 3 | 2 | 1 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Week 12 and q2w through week 22. | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Total of all reporting groups |
| Overall Participants | 19 | 17 | 30 | 30 | 30 | 30 | 31 | 187 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
46.2
(10.24)
|
50.1
(10.72)
|
54.1
(12.72)
|
53.8
(13.02)
|
52
(11)
|
50.9
(10.29)
|
52.8
(9.41)
|
51.8
(11.26)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
11
57.9%
|
14
82.4%
|
25
83.3%
|
27
90%
|
27
90%
|
26
86.7%
|
23
74.2%
|
153
81.8%
|
| Male |
8
42.1%
|
3
17.6%
|
5
16.7%
|
3
10%
|
3
10%
|
4
13.3%
|
8
25.8%
|
34
18.2%
|
| Region of Enrollment (Count of Participants) | ||||||||
| Hungary |
0
0%
|
0
0%
|
2
6.7%
|
5
16.7%
|
3
10%
|
3
10%
|
4
12.9%
|
17
9.1%
|
| Japan |
0
0%
|
0
0%
|
5
16.7%
|
5
16.7%
|
5
16.7%
|
6
20%
|
6
19.4%
|
27
14.4%
|
| Mexico |
0
0%
|
0
0%
|
5
16.7%
|
3
10%
|
4
13.3%
|
5
16.7%
|
6
19.4%
|
23
12.3%
|
| Poland |
13
68.4%
|
12
70.6%
|
9
30%
|
10
33.3%
|
6
20%
|
5
16.7%
|
7
22.6%
|
62
33.2%
|
| Republic of Korea |
0
0%
|
0
0%
|
0
0%
|
1
3.3%
|
1
3.3%
|
2
6.7%
|
1
3.2%
|
5
2.7%
|
| Russian Federation |
0
0%
|
0
0%
|
9
30%
|
6
20%
|
10
33.3%
|
9
30%
|
7
22.6%
|
41
21.9%
|
| United States |
6
31.6%
|
5
29.4%
|
0
0%
|
0
0%
|
1
3.3%
|
0
0%
|
0
0%
|
12
6.4%
|
Outcome Measures
| Title | Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) |
|---|---|
| Description | An American College of Rheumatology (ACR) 50 response is defined as greater than or equal to (>=) 50 percent (%) improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: participant's assessment of pain using Visual Analogue Scale (Score) VAS (0-10 scale, 0=no pain and 10=worst possible pain), participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), participant's assessment of physical function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, the scale 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 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included all randomized participants in Part B. |
| Arm/Group Title | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. |
| Measure Participants | 30 | 30 | 30 | 30 | 31 |
| Number [Percentage of Participants] |
3.3
17.4%
|
26.7
157.1%
|
23.3
77.7%
|
26.7
89%
|
19.4
64.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 100 mg q2 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 100 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.052 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 50 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.026 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.104 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Change From Baseline in Disease Activity Index Score 28 (DAS28) Based on C-reactive Protein (CRP) at Week 12 (Part A and Part B) |
|---|---|
| Description | The 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. A negative change from baseline in DAS28 (CRP) (that is, a decrease from baseline) indicates improvement from baseline. |
| Time Frame | Baseline, Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included randomized subjects in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'n' signifies participants who were evaluable at specific time points, for each arm, respectively. |
| Arm/Group Title | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. |
| Measure Participants | 19 | 17 | 30 | 30 | 30 | 30 | 31 |
| Baseline |
6.341
(0.9034)
|
5.919
(0.9676)
|
5.908
(0.7332)
|
5.755
(0.9706)
|
6.190
(0.6829)
|
6.051
(0.8791)
|
5.688
(0.9529)
|
| Change at Week 12 |
-0.619
(0.8541)
|
-2.075
(0.7979)
|
-1.073
(0.9766)
|
-2.248
(1.2050)
|
-2.011
(0.8843)
|
-2.198
(0.8550)
|
-1.964
(0.9532)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 100 mg q2 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Van Der Waerden ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Part B: Sirukumab 100 mg q4 Weeks, Part B: Sirukumab 50 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Van Der Waerden ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Part B: Sirukumab 100 mg q4 Weeks, Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Van Der Waerden ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Part B: Sirukumab 100 mg q4 Weeks, Part B: Sirukumab 50 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Van Der Waerden ANOVA | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Part B: Sirukumab 100 mg q4 Weeks, Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Van Der Waerden ANOVA | |
| Comments | ||
| Title | Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Week 12 (Part A) |
|---|---|
| Description | An ACR 50 response is defined as >= 50% improvement in both tender joint count (68 joints) and swollen joint count (66 joints) and >= 50% improvement in 3 of the following 5 assessments: Participant's assessment of pain using VAS (0-10 scale, 0=no pain and 10=worst possible pain), Participant's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, [0 = very well to 10 = very poor]), Physician's global assessment of disease activity using VAS (the scale ranges from 0 to 10, [0=no arthritis activity to 10=extremely active arthritis]), Participant's assessment of physical function as measured by HAQ-DI (the scale ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area), and Serum CRP. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included all randomized participants in Part A (excluding a site based on sponsor audit for data integrity). Here 'N'(number of participants analyzed) signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks |
|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. |
| Measure Participants | 17 | 14 |
| Number [Percentage of Participants] |
5.9
31.1%
|
28.6
168.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part B: Placebo, Part B: Sirukumab 100 mg q2 Weeks |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.148 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Serum Sirukumab Concentrations Through Week 38 (Part A) |
|---|---|
| Description | Sirukumab Concentrations in serum were measured. |
| Time Frame | Week 0, Day 2, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 10, Week 10 Day 4, Week 10 Day 7, Week 12, Week 14, Week 18, Week 22, Week 24, and Week 38 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part A (excluding a site based on sponsor audit for data integrity). Here 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure whereas 'n' signifies participants evaluable at specific time points, for each arm, respectively. |
| Arm/Group Title | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks |
|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. |
| Measure Participants | 17 | 14 |
| Week 0 |
NA
(NA)
|
0.01
(0.030)
|
| Day 2 |
NA
(NA)
|
3.73
(2.581)
|
| Day 5 |
NA
(NA)
|
7.40
(3.402)
|
| Day 8 |
NA
(NA)
|
6.01
(2.861)
|
| Day 11 |
NA
(NA)
|
5.42
(1.866)
|
| Week 2 |
NA
(NA)
|
4.78
(1.549)
|
| Week 4 |
NA
(NA)
|
8.83
(3.251)
|
| Week 6 |
NA
(NA)
|
10.49
(3.327)
|
| Week 8 |
NA
(NA)
|
12.36
(3.133)
|
| Week 10 |
NA
(NA)
|
13.49
(3.670)
|
| Week 10 Day 4 |
NA
(NA)
|
19.07
(4.630)
|
| Week 10 Day 7 |
NA
(NA)
|
18.71
(4.111)
|
| Week 12 |
NA
(NA)
|
14.31
(3.438)
|
| Week 14 |
4.78
(1.779)
|
7.07
(2.544)
|
| Week 18 |
8.52
(4.338)
|
2.74
(1.737)
|
| Week 22 |
10.79
(5.830)
|
1.18
(0.816)
|
| Week 24 |
11.37
(6.177)
|
0.88
(0.599)
|
| Week 38 |
0.41
(0.525)
|
0.02
(0.051)
|
| Title | Serum Sirukumab Concentrations Through Week 38 (Part B) |
|---|---|
| Description | Sirukumab Concentrations in serum were measured. |
| Time Frame | Week 0, Day 5, Day 8, Day 11, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 24 Day4, Week 24 Day7, Week 26, Week 28, Week 30, Week 34 and Week 38 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included participants treated with CNTO 136 (Sirukumab) in Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure whereas 'n' signifies participants who were evaluable at specific time points, for each arm, respectively. |
| Arm/Group Title | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. |
| Measure Participants | 26 | 30 | 30 | 30 | 31 |
| Week 0 |
NA
(NA)
|
0.03
(0.087)
|
0.00
(0.000)
|
0.02
(0.076)
|
0.01
(0.048)
|
| Day 5 |
NA
(NA)
|
6.75
(3.212)
|
6.21
(2.933)
|
2.66
(1.447)
|
1.59
(0.808)
|
| Day 8 |
NA
(NA)
|
5.67
(2.398)
|
5.85
(2.774)
|
2.61
(1.339)
|
1.49
(0.556)
|
| Day 11 |
0.02
(0.063)
|
4.50
(2.307)
|
4.68
(2.539)
|
2.54
(1.233)
|
1.26
(0.516)
|
| Week 2 |
NA
(NA)
|
4.30
(2.265)
|
3.81
(1.934)
|
1.97
(0.916)
|
1.16
(0.426)
|
| Week 4 |
NA
(NA)
|
7.16
(3.290)
|
2.02
(1.073)
|
0.97
(0.470)
|
0.85
(1.167)
|
| Week 8 |
NA
(NA)
|
10.54
(5.008)
|
3.08
(1.806)
|
1.45
(0.764)
|
0.99
(0.560)
|
| Week 12 |
NA
(NA)
|
11.63
(5.232)
|
3.10
(1.633)
|
1.79
(0.836)
|
0.99
(0.478)
|
| Week 16 |
6.84
(2.270)
|
9.96
(5.107)
|
3.51
(2.545)
|
2.03
(1.366)
|
0.98
(0.425)
|
| Week 20 |
9.94
(3.646)
|
10.29
(4.951)
|
3.92
(2.665)
|
1.80
(1.030)
|
1.03
(0.496)
|
| Week 24 |
11.04
(4.607)
|
10.73
(5.182)
|
3.80
(2.815)
|
1.89
(1.042)
|
1.04
(0.491)
|
| Week 24 Day 4 |
16.46
(6.826)
|
17.34
(9.046)
|
9.06
(5.632)
|
4.42
(1.293)
|
3.36
(1.578)
|
| Week 24 Day 7 |
15.14
(5.991)
|
15.01
(7.853)
|
9.58
(5.721)
|
4.52
(1.719)
|
2.80
(1.580)
|
| Week 26 |
10.97
(4.565)
|
10.09
(6.808)
|
6.49
(5.401)
|
3.72
(1.434)
|
1.91
(1.009)
|
| Week 28 |
6.93
(3.378)
|
6.69
(4.329)
|
4.15
(2.830)
|
1.84
(0.764)
|
1.06
(0.539)
|
| Week 30 |
4.49
(2.708)
|
4.06
(2.341)
|
2.42
(1.931)
|
1.07
(0.529)
|
0.52
(0.335)
|
| Week 34 |
1.88
(1.451)
|
1.92
(1.403)
|
0.94
(0.948)
|
0.39
(0.396)
|
0.10
(0.138)
|
| Week 38 |
0.71
(0.756)
|
0.72
(0.704)
|
0.29
(0.382)
|
0.08
(0.114)
|
0.01
(0.037)
|
| Title | Percent Improvement From Baseline in Serum C-Reactive Protein (CRP) At Week 2 (Part A and Part B) |
|---|---|
| Description | Serum CRP is a marker of systemic inflammation. A negative change from baseline in CRP represents improvement. |
| Time Frame | Baseline, Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Population analyzed included randomized participants in Part A (excluding a site based on sponsor audit for data integrity) and Part B. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. |
| Arm/Group Title | Part B: Placebo | Part B: Sirukumab 100 mg q2 Weeks | Part B: Sirukumab 100 mg q4 Weeks | Part B: Sirukumab 50 mg q4 Weeks | Part B: Sirukumab 25 mg q4 Weeks | Part A: Placebo | Part A: Sirukumab 100 mg q2 Weeks |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 milligram (mg) beginning at Week 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumabat subcutaneously at Week 0 and every 4 weeks (q4w) for 24 weeks and placebo SC injections at Weeks 2, 6, and q4w through week 22. | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. |
| Measure Participants | 30 | 30 | 30 | 30 | 31 | 17 | 14 |
| Mean (Standard Deviation) [Percent change] |
-49.31
(246.040)
|
81.46
(25.000)
|
88.53
(12.675)
|
85.42
(18.242)
|
81.22
(24.484)
|
19.97
(41.232)
|
91.19
(4.812)
|
Adverse Events
| Time Frame | Screening up to Week 38 | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety population (SP) included all participants who received at least 1 dose of study agent (including safety data from all investigator sites irrespective of audit findings). | |||||||||||||||||||
| Arm/Group Title | Part A - Placebo (Wk 0-Wk 12) | Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Part A - Sirukumab (Wk 0-Wk 12) | Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Part B - Placebo (Wk 0-Wk 12) | Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Part B - Sirukumab 100mg q2w | Part B - Sirukumab 100mg q4w | Part B - Sirukumab 50mg q4w | Part B - Sirukumab 25mg q4w | ||||||||||
| Arm/Group Description | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. Thereafter participants received placebo beginning at Weeks 12 and q2w through week 22. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) for Week 10. | Participants received placebo at Weeks 12 and q2w through Week 22. | Participants received placebo subcutaneously (SC) at Week 0 and q2w for 10 weeks. | Participants received placebo subcutaneously (SC) at Week 0 and every 2 weeks (q2w) for 10 weeks. Thereafter participants received sirukumab 100 mg beginning at Weeks 12 and q2w through week 24. | Participants received 100 mg of sirukumab subcutaneously at Weeks 0, 2 and every 2 weeks (q2w) through Week 24. | Participants received 100 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | Participants received 50 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | Participants received 25 mg of sirukumab subcutaneously every 4 weeks (q4w) for 24 weeks and in between placebo SC injections was received at Weeks 2, 6, and q4w through week 22. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Part A - Placebo (Wk 0-Wk 12) | Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Part A - Sirukumab (Wk 0-Wk 12) | Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Part B - Placebo (Wk 0-Wk 12) | Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Part B - Sirukumab 100mg q2w | Part B - Sirukumab 100mg q4w | Part B - Sirukumab 50mg q4w | Part B - Sirukumab 25mg q4w | |||||||||||
| 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 |
||||||||||||||||||||
| Part A - Placebo (Wk 0-Wk 12) | Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Part A - Sirukumab (Wk 0-Wk 12) | Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Part B - Placebo (Wk 0-Wk 12) | Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Part B - Sirukumab 100mg q2w | Part B - Sirukumab 100mg q4w | Part B - Sirukumab 50mg q4w | Part B - Sirukumab 25mg q4w | |||||||||||
| 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 | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 4/30 (13.3%) | 2/26 (7.7%) | 2/30 (6.7%) | 5/30 (16.7%) | 1/30 (3.3%) | 3/31 (9.7%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Blindness | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Appendicitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Arthritis Bacterial | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Bursitis Infective | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Cellulitis Staphylococcal | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Pelvic Inflammatory Disease | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Pneumonia | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Pyelonephritis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Transaminases Increased | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Rheumatoid Arthritis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||
| Fibrosarcoma | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Facial Paresis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Intracranial Aneurysm | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Subarachnoid Haemorrhage | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Vertebral Artery Occlusion | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||
| Uterine Polyp | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Skin Ulcer | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Part A - Placebo (Wk 0-Wk 12) | Part A - Placebo Then Sirukumab (Wk 12 to End of Study) | Part A - Sirukumab (Wk 0-Wk 12) | Part A - Sirukumab Then Placebo (Wk 12 to End of Study) | Part B - Placebo (Wk 0-Wk 12) | Part B - Placebo Then Sirukumab 100 mg q2 Weeks | Part B - Sirukumab 100mg q2w | Part B - Sirukumab 100mg q4w | Part B - Sirukumab 50mg q4w | Part B - Sirukumab 25mg q4w | |||||||||||
| 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 | 12/19 (63.2%) | 18/18 (100%) | 12/17 (70.6%) | 10/16 (62.5%) | 15/30 (50%) | 11/26 (42.3%) | 20/30 (66.7%) | 18/30 (60%) | 25/30 (83.3%) | 23/31 (74.2%) | ||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||
| Haemorrhagic Diathesis | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Leukopenia | 0/19 (0%) | 1/18 (5.6%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 3/26 (11.5%) | 4/30 (13.3%) | 4/30 (13.3%) | 5/30 (16.7%) | 3/31 (9.7%) | ||||||||||
| Neutropenia | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 2/30 (6.7%) | 2/30 (6.7%) | 0/31 (0%) | ||||||||||
| Thrombocytopenia | 0/19 (0%) | 2/18 (11.1%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 1/30 (3.3%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Cardiac disorders | ||||||||||||||||||||
| Bundle Branch Block Left | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Tinnitus | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Vertigo | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Eye disorders | ||||||||||||||||||||
| Eye Pain | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Uveitis | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Vision Blurred | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal Pain | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 1/30 (3.3%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Abdominal Pain Upper | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 2/30 (6.7%) | 1/31 (3.2%) | ||||||||||
| Aphthous Stomatitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 1/30 (3.3%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Colitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 3/31 (9.7%) | ||||||||||
| Diarrhoea | 1/19 (5.3%) | 0/18 (0%) | 3/17 (17.6%) | 0/16 (0%) | 1/30 (3.3%) | 1/26 (3.8%) | 2/30 (6.7%) | 0/30 (0%) | 1/30 (3.3%) | 1/31 (3.2%) | ||||||||||
| Dyspepsia | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 2/31 (6.5%) | ||||||||||
| Periodontitis | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Stomatitis | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Vomiting | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Fatigue | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Injection Site Erythema | 0/19 (0%) | 4/18 (22.2%) | 6/17 (35.3%) | 0/16 (0%) | 1/30 (3.3%) | 2/26 (7.7%) | 3/30 (10%) | 2/30 (6.7%) | 4/30 (13.3%) | 6/31 (19.4%) | ||||||||||
| Injection Site Pain | 1/19 (5.3%) | 1/18 (5.6%) | 4/17 (23.5%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Injection Site Pruritus | 0/19 (0%) | 0/18 (0%) | 2/17 (11.8%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Injection Site Rash | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 2/30 (6.7%) | 0/31 (0%) | ||||||||||
| Injection Site Swelling | 0/19 (0%) | 1/18 (5.6%) | 2/17 (11.8%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Injection Site Urticaria | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Injection Site Warmth | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Pyrexia | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Hepatobiliary disorders | ||||||||||||||||||||
| Hepatitis | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Acute Tonsillitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 2/30 (6.7%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Bronchitis | 2/19 (10.5%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Gastroenteritis | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 1/30 (3.3%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Herpes Zoster | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Lymphangitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Nasopharyngitis | 1/19 (5.3%) | 2/18 (11.1%) | 2/17 (11.8%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 5/30 (16.7%) | 0/30 (0%) | 1/30 (3.3%) | 2/31 (6.5%) | ||||||||||
| Pharyngitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 1/30 (3.3%) | 2/30 (6.7%) | 2/31 (6.5%) | ||||||||||
| Pneumonia | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Rhinitis | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Sinusitis | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 2/30 (6.7%) | 1/31 (3.2%) | ||||||||||
| Staphylococcal Skin Infection | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Upper Respiratory Tract Infection | 2/19 (10.5%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 3/30 (10%) | 3/30 (10%) | 2/31 (6.5%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Synovial Rupture | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Investigations | ||||||||||||||||||||
| Alanine Aminotransferase Increased | 0/19 (0%) | 4/18 (22.2%) | 2/17 (11.8%) | 0/16 (0%) | 1/30 (3.3%) | 1/26 (3.8%) | 4/30 (13.3%) | 7/30 (23.3%) | 10/30 (33.3%) | 6/31 (19.4%) | ||||||||||
| Aspartate Aminotransferase Increased | 0/19 (0%) | 0/18 (0%) | 2/17 (11.8%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 3/30 (10%) | 4/30 (13.3%) | 6/30 (20%) | 3/31 (9.7%) | ||||||||||
| Blood Bilirubin Increased | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 2/30 (6.7%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Blood Cholesterol Increased | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 3/30 (10%) | 1/30 (3.3%) | 1/31 (3.2%) | ||||||||||
| Blood Glucose Increased | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Blood Insulin Increased | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) | 0/31 (0%) | ||||||||||
| Blood Potassium Decreased | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 2/16 (12.5%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Haemoglobin Decreased | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 2/30 (6.7%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Insulin Resistance Test | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) | 0/31 (0%) | ||||||||||
| Intraocular Pressure Increased | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Transaminases Increased | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 1/26 (3.8%) | 1/30 (3.3%) | 0/30 (0%) | 1/30 (3.3%) | 2/31 (6.5%) | ||||||||||
| White Blood Cell Count Decreased | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 1/26 (3.8%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 2/31 (6.5%) | ||||||||||
| Metabolism and nutrition disorders | ||||||||||||||||||||
| Hypercholesterolaemia | 1/19 (5.3%) | 1/18 (5.6%) | 5/17 (29.4%) | 2/16 (12.5%) | 1/30 (3.3%) | 0/26 (0%) | 5/30 (16.7%) | 1/30 (3.3%) | 2/30 (6.7%) | 4/31 (12.9%) | ||||||||||
| Hyperlipidaemia | 0/19 (0%) | 1/18 (5.6%) | 1/17 (5.9%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 1/31 (3.2%) | ||||||||||
| Hypokalaemia | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 2/31 (6.5%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Arthralgia | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | 1/30 (3.3%) | 1/26 (3.8%) | 2/30 (6.7%) | 1/30 (3.3%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Intervertebral Disc Degeneration | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Musculoskeletal Chest Pain | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 1/30 (3.3%) | 1/31 (3.2%) | ||||||||||
| Musculoskeletal Pain | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Neck Pain | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Pain in Extremity | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 2/30 (6.7%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Rheumatoid Arthritis | 2/19 (10.5%) | 1/18 (5.6%) | 1/17 (5.9%) | 2/16 (12.5%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 1/30 (3.3%) | 3/30 (10%) | 1/31 (3.2%) | ||||||||||
| Spinal Column Stenosis | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Tendon Pain | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Dizziness | 1/19 (5.3%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 3/30 (10%) | 1/26 (3.8%) | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Headache | 1/19 (5.3%) | 1/18 (5.6%) | 0/17 (0%) | 1/16 (6.3%) | 2/30 (6.7%) | 1/26 (3.8%) | 2/30 (6.7%) | 1/30 (3.3%) | 1/30 (3.3%) | 2/31 (6.5%) | ||||||||||
| Migraine | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Sciatica | 0/19 (0%) | 1/18 (5.6%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Psychiatric disorders | ||||||||||||||||||||
| Anxiety | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 1/30 (3.3%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Upper Respiratory Tract Inflammation | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 1/30 (3.3%) | 2/26 (7.7%) | 0/30 (0%) | 1/30 (3.3%) | 1/30 (3.3%) | 0/31 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Dry Skin | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Rash | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Urticaria | 0/19 (0%) | 0/18 (0%) | 1/17 (5.9%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 1/31 (3.2%) | ||||||||||
| Vascular disorders | ||||||||||||||||||||
| Haematoma | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 0/30 (0%) | 0/26 (0%) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
| Hypertension | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 1/16 (6.3%) | 2/30 (6.7%) | 0/26 (0%) | 2/30 (6.7%) | 0/30 (0%) | 0/30 (0%) | 3/31 (9.7%) | ||||||||||
| Thrombophlebitis | 0/19 (0%) | 0/18 (0%) | 0/17 (0%) | 0/16 (0%) | 0/30 (0%) | 0/26 (0%) | 2/30 (6.7%) | 0/30 (0%) | 0/30 (0%) | 0/31 (0%) | ||||||||||
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 | |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00718718
Other Study ID Numbers:
- CR015214
- C1377T04
- 2007-006603-20
First Posted:
Jul 21, 2008
Last Update Posted:
Jan 23, 2018
Last Verified:
Dec 1, 2017