Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Sponsor
CSL Behring (Industry)
Overall Status
Completed
CT.gov ID
NCT01373151
Collaborator
(none)
418
100
7
48
4.2
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
418 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.
Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Sep 1, 2012
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Arm 1 BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo |
Drug: BMS-945429 Placebo
Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Experimental: Arm 2 BMS-945429 + Methotrexate + Adalimumab Placebo |
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Experimental: Arm 3 BMS-945429 + Methotrexate + Adalimumab Placebo |
Biological: BMS-945429
Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Experimental: Arm 4 BMS-945429 + Methotrexate + Adalimumab Placebo |
Biological: BMS-945429
Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Experimental: Arm 5 BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo |
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate Placebo
Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Experimental: Arm 6 BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo |
Biological: BMS-945429
Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate Placebo
Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
|
| Active Comparator: Arm 7 Adalimumab + Methotrexate |
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab
Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
|
Outcome Measures
Primary Outcome Measures
- Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate [At 12 Weeks]
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Secondary Outcome Measures
- Percent of Participants With ACR 20 Response [At 24 weeks]
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
- Percent of Participants Achieving ACR 50 Response Rate [At weeks 12 and 24]
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
- Percent of Participants Achieving ACR 70 Response Rate [At weeks 12 and 24]
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
- Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) [Baseline, weeks 12 and 24]
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
- Percent of Participants With Remission by DAS28-CRP [At weeks 12 and 24]
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
- Mean Change From Baseline in Clinical Disease Activity Index (CDAI) [Baseline, weeks 12 and 24]
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
- Percent of Participants With Remission by CDAI [At weeks 12 and 24]
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
- Mean Change From Baseline in Simplified Disease Activity Index (SDAI) [Baseline, weeks 12 and 24]
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
- Percent of Participants With Remission by SDAI [At weeks 12 and 24]
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
- Percent of Participants With Remission Rate by Boolean Definition [At weeks 12 and 24]
Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
- Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index [Baseline, weeks 12 and 24]
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
- Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components [Baseline, weeks 12 and 24]
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
- Mean Change From Baseline in Fatigue Severity (VAS) Score [Baseline, weeks 12 and 24]
A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores [Baseline, weeks 12 and 24]
The WPAI yeilds four types of scores: Absenteeism (work time missed) Presenteesism (impairment at work / reduced on-the-job effectiveness) Work productivty loss (overall work impairment / absenteeism plus presenteeism) Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.
- Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing) [Baseline and week 12]
- Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score [Baseline and week 24]
The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Inadequate response to Methotrexate
-
Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
-
American College of Rheumatology (ACR) global function status class 1-3
-
Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
-
High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL
Exclusion Criteria:
- Previously received or currently receiving concomitant biologic therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Valley Arthritis Center, Ltd. | Peoria | Arizona | United States | 85381 |
| 2 | San Diego Arthritis Medical Clinic | San Diego | California | United States | 92108 |
| 3 | New England Research Associates, Llc | Trumbull | Connecticut | United States | 06611 |
| 4 | Quincy Medical Group | Quincy | Illinois | United States | 62301 |
| 5 | Rockford Orthopedic Associates, Llc. | Rockford | Illinois | United States | 61107 |
| 6 | Clinical Pharmacology Study Group | Worcester | Massachusetts | United States | 01605 |
| 7 | Arthritis Associates Of Mississippi | Jackson | Mississippi | United States | 39202 |
| 8 | Physician Research Collaboration, Llc | Lincoln | Nebraska | United States | 68516 |
| 9 | Box Arthritis And Rheumatology Of The Carolinas, Pllc | Charlotte | North Carolina | United States | 28210 |
| 10 | Health Research Of Oklahoma | Oklahoma City | Oklahoma | United States | 73103 |
| 11 | East Penn Rheumatology Associates, P.C. | Bethlehem | Pennsylvania | United States | 18015 |
| 12 | Altoona Center For Clinical Research | Duncansville | Pennsylvania | United States | 16635 |
| 13 | Seattle Rheumatology Associates | Seattle | Washington | United States | 98104 |
| 14 | Local Institution | Capital Federal | Buenos Aires | Argentina | 1015 |
| 15 | Local Institution | Capital Federal | Buenos Aires | Argentina | 1425 |
| 16 | Local Institution | Capital Federal | Buenos Aires | Argentina | 1428 |
| 17 | Local Institution | Capital Federal | Buenos Aires | Argentina | 1431 |
| 18 | Local Institution | Rosario | Santa FE | Argentina | 2000 |
| 19 | Local Institution | San Miguel De Tucuman | Tucuman | Argentina | 4000 |
| 20 | Local Institution | Cordoba | Argentina | 5000 | |
| 21 | Local Institution | San Juan | Argentina | 5400 | |
| 22 | Local Institution | Bruxelles | Belgium | 1200 | |
| 23 | Local Institution | Hasselt | Belgium | 3500 | |
| 24 | Local Institution | Goiania | Goias | Brazil | 74110 |
| 25 | Local Institution | Juiz De Fora | Minas Gerais | Brazil | 36010 |
| 26 | Local Institution | Curitiba | Parana | Brazil | 80060 |
| 27 | Local Institution | Curitiba | Parana | Brazil | 80440 |
| 28 | Local Institution | Porto Alegre | Rio Grande Do Sul | Brazil | 91610 |
| 29 | Local Institution | Sao Paulo | Brazil | 04032 | |
| 30 | Local Institution | Sao Paulo | Brazil | 04266 | |
| 31 | Local Institution | Montreal | Quebec | Canada | H2L 1S6 |
| 32 | Centre De Recherche Musculo-Squelettique | Trois-rivieres | Quebec | Canada | G8Z 1Y2 |
| 33 | Local Institution | Quebec | Canada | G1W 4R4 | |
| 34 | Local Institution | Praha 2 | Czechia | 128 50 | |
| 35 | Local Institution | Praha 4 | Czechia | 140 59 | |
| 36 | Local Institution | Bordeaux Cedex | France | 33076 | |
| 37 | Local Institution | Chambray Les Tours | France | 37170 | |
| 38 | Local Institution | Strasbourg Cedex | France | 67098 | |
| 39 | Local Institution | Berlin | Germany | 14059 | |
| 40 | Local Institution | Koeln | Germany | 50931 | |
| 41 | Local Institution | Leipzig | Germany | 04103 | |
| 42 | Local Institution | Wuerzburg | Germany | 97080 | |
| 43 | Local Institution | Budapest | Hungary | 1027 | |
| 44 | Local Institution | Debrecen | Hungary | 4012 | |
| 45 | Local Institution | Gyula | Hungary | 5700 | |
| 46 | Local Institution | Veszprem | Hungary | 8200 | |
| 47 | Local Institution | Napoli | Italy | 80131 | |
| 48 | Local Institution | Padova | Italy | 35128 | |
| 49 | Local Institution | Reggio Emilia | Italy | 42100 | |
| 50 | Local Institution | Chiba-shi | Chiba | Japan | 2608712 |
| 51 | Local Institution | Kitakyushu-shi | Fukuoka | Japan | 8078555 |
| 52 | Local Institution | Higashi-hiroshima-shi | Hiroshima | Japan | 7390002 |
| 53 | Local Institution | Kato-shi | Hyogo | Japan | 6731462 |
| 54 | Local Institution | Miyazaki-shi | Miyazaki | Japan | 8800122 |
| 55 | Local Institution | Nagano-shi | Nagano | Japan | 3808582 |
| 56 | Local Institution | Nagasaki-shi | Nagasaki | Japan | 8528501 |
| 57 | Local Institution | Sasebo-shi | Nagasaki | Japan | 8571195 |
| 58 | Local Institution | Tomigusuku-shi | Okinawa | Japan | 9010243 |
| 59 | Local Institution | Osaka-shi | Osaka | Japan | 5458586 |
| 60 | Local Institution | Shizuoka-shi | Shizuoka | Japan | 4208623 |
| 61 | Local Institution | Bunkyo-ku | Tokyo | Japan | 1138519 |
| 62 | Local Institution | Shinjuku-Ku | Tokyo | Japan | 1608582 |
| 63 | Local Institution | Toshima-ku | Tokyo | Japan | 1708476 |
| 64 | Local Institution | Daegu | Korea, Republic of | 705-718 | |
| 65 | Local Institution | Seoul | Korea, Republic of | 133-792 | |
| 66 | Local Institution | Seoul | Korea, Republic of | 137-701 | |
| 67 | Local Institution | Mexico City | Distrito Federal | Mexico | 11850 |
| 68 | Local Institution | Guadalajara | Jalisco | Mexico | 42650 |
| 69 | Local Institution | Guadalajara | Jalisco | Mexico | 45040 |
| 70 | Local Institution | Morelia | Michioacan | Mexico | 58270 |
| 71 | Local Institution | Monterrey | Nuevo Leon | Mexico | 64020 |
| 72 | Local Institution | Culiacan | Sinaloa | Mexico | 80230 |
| 73 | Local Institution | San Luis Potosi | Mexico | 78213 | |
| 74 | Local Institution | Amsterdam | Netherlands | 1056 AB | |
| 75 | Local Institution | Katowice | Poland | 40-748 | |
| 76 | Local Institution | Krakow | Poland | 31-531 | |
| 77 | Local Institution | Poznan | Poland | 60773 | |
| 78 | Local Institution | Warszawa | Poland | 01-868 | |
| 79 | Local Institution | Warszawa | Poland | 02-118 | |
| 80 | Local Institution | Ekaterinburg | Russian Federation | 620102 | |
| 81 | Local Institution | Kazan | Russian Federation | 420064 | |
| 82 | Local Institution | Moscow | Russian Federation | 115522 | |
| 83 | Local Institution | Novosibirsk | Russian Federation | 630005 | |
| 84 | Local Institution | St. Petersburg | Russian Federation | 191014 | |
| 85 | Local Institution | Yaroslavl | Russian Federation | 150003 | |
| 86 | Local Institution | Pretoria | Gauteng | South Africa | 0083 |
| 87 | Local Institution | Pretoria | Gauteng | South Africa | 0132 |
| 88 | Local Institution | Durban | KWA ZULU Natal | South Africa | 4001 |
| 89 | Local Institution | Panorama | Western CAPE | South Africa | 7500 |
| 90 | Local Institution | Pinelands, Cape Town | Western Cape | South Africa | 7405 |
| 91 | Local Institution | Tygerberg | Western CAPE | South Africa | 7505 |
| 92 | Local Institution | A Coruna | Spain | 15006 | |
| 93 | Local Institution | Madrid | Spain | 28040 | |
| 94 | Local Institution | Santander | Spain | 39008 | |
| 95 | Local Institution | Santiago De Compostela | Spain | 15706 | |
| 96 | Local Institution | Sevilla | Spain | 41071 | |
| 97 | Local Institution | Changhua | Taiwan | 500 | |
| 98 | Local Institution | Kaohsiung | Taiwan | 833 | |
| 99 | Local Institution | Taichung | Taiwan | 404 | |
| 100 | Local Institution | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- CSL Behring
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
CSL Behring
ClinicalTrials.gov Identifier:
NCT01373151
Other Study ID Numbers:
- IM133-001
- 2010-023956-99
First Posted:
Jun 14, 2011
Last Update Posted:
Dec 6, 2021
Last Verified:
Nov 1, 2021
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Period Title: Period 1 | |||||||
| STARTED | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| COMPLETED | 56 | 59 | 56 | 59 | 54 | 56 | 59 |
| NOT COMPLETED | 5 | 0 | 4 | 1 | 5 | 4 | 0 |
| Period Title: Period 1 | |||||||
| STARTED | 56 | 58 | 56 | 59 | 54 | 55 | 59 |
| COMPLETED | 47 | 57 | 52 | 54 | 52 | 55 | 54 |
| NOT COMPLETED | 9 | 1 | 4 | 5 | 2 | 0 | 5 |
Baseline Characteristics
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks | Total of all reporting groups |
| Overall Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 | 418 |
| Age (Count of Participants) | ||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
54
88.5%
|
56
94.9%
|
47
78.3%
|
52
86.7%
|
51
86.4%
|
55
91.7%
|
51
86.4%
|
366
87.6%
|
| >=65 years |
7
11.5%
|
3
5.1%
|
13
21.7%
|
8
13.3%
|
8
13.6%
|
5
8.3%
|
8
13.6%
|
52
12.4%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
51.4
(11.03)
|
47.4
(10.97)
|
55.0
(12.21)
|
49.9
(13.95)
|
50.0
(12.53)
|
46.4
(11.91)
|
52.8
(11.41)
|
50.4
(12.26)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
46
75.4%
|
46
78%
|
52
86.7%
|
53
88.3%
|
49
83.1%
|
49
81.7%
|
48
81.4%
|
343
82.1%
|
| Male |
15
24.6%
|
13
22%
|
8
13.3%
|
7
11.7%
|
10
16.9%
|
11
18.3%
|
11
18.6%
|
75
17.9%
|
Outcome Measures
| Title | Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate |
|---|---|
| Description | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). |
| Time Frame | At 12 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| Number [percentage of participants] |
39.3
64.4%
|
76.3
129.3%
|
55.0
91.7%
|
73.3
122.2%
|
61.0
103.4%
|
60.0
100%
|
76.3
129.3%
|
| Title | Percent of Participants With ACR 20 Response |
|---|---|
| Description | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). |
| Time Frame | At 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| Number [percentage of participants] |
37.7
61.8%
|
81.4
138%
|
58.3
97.2%
|
65.0
108.3%
|
57.6
97.6%
|
66.7
111.2%
|
66.1
112%
|
| Title | Percent of Participants Achieving ACR 50 Response Rate |
|---|---|
| Description | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| 12 weeks |
21.3
34.9%
|
49.2
83.4%
|
26.7
44.5%
|
43.3
72.2%
|
28.8
48.8%
|
26.7
44.5%
|
30.5
51.7%
|
| 24 weeks |
16.4
26.9%
|
47.5
80.5%
|
36.7
61.2%
|
46.7
77.8%
|
33.9
57.5%
|
43.3
72.2%
|
47.5
80.5%
|
| Title | Percent of Participants Achieving ACR 70 Response Rate |
|---|---|
| Description | The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP). |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| 12 weeks |
8.2
13.4%
|
18.6
31.5%
|
13.3
22.2%
|
26.7
44.5%
|
11.9
20.2%
|
13.3
22.2%
|
11.9
20.2%
|
| 24 weeks |
6.6
10.8%
|
27.1
45.9%
|
16.7
27.8%
|
40.0
66.7%
|
25.4
43.1%
|
30.0
50%
|
18.6
31.5%
|
| Title | Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP) |
|---|---|
| Description | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| 12 weeks |
-1.15
(0.1652)
|
-2.65
(0.1610)
|
-2.29
(0.1603)
|
-2.68
(0.1597)
|
-2.34
(0.1665)
|
-2.52
(0.1610)
|
-2.04
(0.1647)
|
| 24 weeks |
-1.69
(0.1825)
|
-3.01
(0.1684)
|
-2.60
(0.1719)
|
-3.06
(0.1713)
|
-2.55
(0.1769)
|
-2.95
(0.1706)
|
-2.52
(0.1769)
|
| Title | Percent of Participants With Remission by DAS28-CRP |
|---|---|
| Description | DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission. |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
1.6
2.6%
|
35.6
60.3%
|
21.7
36.2%
|
35.0
58.3%
|
25.4
43.1%
|
26.7
44.5%
|
20.3
34.4%
|
| week 24 |
11.5
18.9%
|
49.2
83.4%
|
25.0
41.7%
|
40.0
66.7%
|
35.6
60.3%
|
41.7
69.5%
|
23.7
40.2%
|
| Title | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) |
|---|---|
| Description | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated participants (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
-14.5
(1.727)
|
-22.7
(1.686)
|
-17.7
(1.687)
|
-23.1
(1.701)
|
-19.8
(1.738)
|
-21.0
(1.697)
|
-22.4
(1.702)
|
| week 24 |
-20.3
(1.703)
|
-26.1
(1.587)
|
-22.0
(1.613)
|
-26.9
(1.622)
|
-21.7
(1.643)
|
-25.6
(1.606)
|
-26.2
(1.631)
|
| Title | Percent of Participants With Remission by CDAI |
|---|---|
| Description | CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
3.3
5.4%
|
11.9
20.2%
|
8.3
13.8%
|
8.3
13.8%
|
3.4
5.8%
|
3.3
5.5%
|
8.5
14.4%
|
| week 24 |
1.6
2.6%
|
15.3
25.9%
|
6.7
11.2%
|
21.7
36.2%
|
6.8
11.5%
|
20.0
33.3%
|
8.5
14.4%
|
| Title | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) |
|---|---|
| Description | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
-14.5
(1.794)
|
-24.9
(1.749)
|
-20.4
(1.745)
|
-25.3
(1.734)
|
-22.2
(1.811)
|
-23.3
(1.747)
|
-23.2
(1.785)
|
| week 24 |
-20.6
(1.812)
|
-28.4
(1.670)
|
-24.5
(1.704)
|
-29.1
(1.698)
|
-23.5
(1.755)
|
-27.6
(1.691)
|
-27.6
(1.752)
|
| Title | Percent of Participants With Remission by SDAI |
|---|---|
| Description | SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
1.6
2.6%
|
11.9
20.2%
|
8.3
13.8%
|
8.3
13.8%
|
6.8
11.5%
|
5.0
8.3%
|
10.2
17.3%
|
| week 24 |
4.9
8%
|
18.6
31.5%
|
6.7
11.2%
|
20.
33.3%
|
6.8
11.5%
|
23.3
38.8%
|
8.5
14.4%
|
| Title | Percent of Participants With Remission Rate by Boolean Definition |
|---|---|
| Description | Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale) |
| Time Frame | At weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
3.3
5.4%
|
8.5
14.4%
|
6.7
11.2%
|
10.
16.7%
|
1.7
2.9%
|
5.0
8.3%
|
5.1
8.6%
|
| week 24 |
1.6
2.6%
|
10.2
17.3%
|
5.0
8.3%
|
13.3
22.2%
|
5.1
8.6%
|
18.3
30.5%
|
10.2
17.3%
|
| Title | Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index |
|---|---|
| Description | Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22. |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
-0.44
(0.0827)
|
-0.66
(0.0801)
|
-0.47
(0.0807)
|
-0.70
(0.0811)
|
-0.51
(0.0834)
|
-0.60
(0.0807)
|
-0.60
(0.0819)
|
| week 24 |
-0.62
(0.0861)
|
-0.68
(0.0806)
|
-0.64
(0.0823)
|
-0.79
(0.0823)
|
-0.60
(0.0840)
|
-0.71
(0.0811)
|
-0.66
(0.0833)
|
| Title | Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components |
|---|---|
| Description | The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status. |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| Mental component (week 12) |
5.3
(1.274)
|
5.9
(1.240)
|
4.5
(1.251)
|
7.3
(1.244)
|
4.0
(1.283)
|
5.7
(1.230)
|
6.4
(1.250)
|
| Mental component (week 24) |
6.0
(1.327)
|
6.4
(1.208)
|
6.6
(1.247)
|
7.5
(1.247)
|
5.3
(1.271)
|
8.0
(1.219)
|
7.1
(1.246)
|
| Physical component (week 12) |
4.0
(1.030)
|
7.5
(0.999)
|
7.3
(1.010)
|
9.5
(1.002)
|
6.8
(1.028)
|
7.3
(0.994)
|
8.4
(1.006)
|
| Physical component (week 24) |
6.2
(1.149)
|
8.6
(1.045)
|
9.4
(1.080)
|
10.9
(1.076)
|
7.7
(1.094)
|
8.2
(1.057)
|
8.2
(1.077)
|
| Title | Mean Change From Baseline in Fatigue Severity (VAS) Score |
|---|---|
| Description | A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
-14.3
(3.146)
|
-20.8
(3.060)
|
-19.4
(3.077)
|
-27.4
(3.077)
|
-21.7
(3.180)
|
-18.6
(3.056)
|
-26.3
(3.080)
|
| week 24 |
-12.9
(3.306)
|
-23.9
(3.052)
|
-22.3
(3.131)
|
-31.3
(3.103)
|
-17.7
(3.184)
|
-23.4
(3.056)
|
-27.0
(3.134)
|
| Title | Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores |
|---|---|
| Description | The WPAI yeilds four types of scores: Absenteeism (work time missed) Presenteesism (impairment at work / reduced on-the-job effectiveness) Work productivty loss (overall work impairment / absenteeism plus presenteeism) Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity. |
| Time Frame | Baseline, weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| week 12 |
-9.6
(3.273)
|
-2.2
(3.443)
|
-8.7
(3.673)
|
-12.0
(3.081)
|
-13.7
(3.285)
|
-10.0
(3.575)
|
-11.7
(6.281)
|
| week 24 |
-10.7
(4.033)
|
-1.8
(3.893)
|
-17.1
(4.200)
|
-12.1
(3.448)
|
-5.9
(3.788)
|
-12.6
(3.938)
|
-4.7
(6.379)
|
| Title | Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing) |
|---|---|
| Description | |
| Time Frame | Baseline and week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 61 | 59 | 60 | 60 | 59 | 60 | 59 |
| Erosion |
1.3
(0.352)
|
0.4
(0.341)
|
1.1
(0.356)
|
0.3
(0.334)
|
1.0
(0.369)
|
-0.2
(0.341)
|
-0.5
(0.348)
|
| Edema |
0.2
(1.009)
|
-6.4
(0.993)
|
-2.6
(1.015)
|
-4.7
(0.998)
|
-4.6
(1.036)
|
-5.1
(0.993)
|
-3.1
(1.008)
|
| Synovitis |
-0.5
(0.436)
|
-2.5
(0.427)
|
-1.4
(0.440)
|
-2.2
(0.426)
|
-2.9
(0.447)
|
-2.5
(0.427)
|
-2.9
(0.435)
|
| Narrowing |
0.1
(0.133)
|
-0.1
(0.130)
|
0.2
(0.135)
|
-0.1
(0.126)
|
0.1
(0.139)
|
0.0
(0.129)
|
-0.2
(0.132)
|
| Title | Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score |
|---|---|
| Description | The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage. |
| Time Frame | Baseline and week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized and treated subjects (participants with missing values at each timepoint were not included) |
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks |
| Measure Participants | 44 | 59 | 54 | 54 | 53 | 53 | 54 |
| Mean (Standard Error) [score on a scale] |
1.8
(0.353)
|
0.3
(0.320)
|
0.0
(0.327)
|
0.1
(0.324)
|
0.1
(0.330)
|
0.1
(0.336)
|
0.1
(0.333)
|
Adverse Events
| Time Frame | Up to 48 weeks per participant | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||
| Arm/Group Title | Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX | |||||||
| Arm/Group Description | BMS-945429 (Clazakizumab)Placebo/BMS-945429+Methotrexate+Adalimumab Placebo BMS-945429 Placebo: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo BMS-945429: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks Methotrexate Placebo: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only Methotrexate: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only Adalimumab Placebo: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks | Adalimumab(ADA) + Methotrexate Methotrexate: Tablets, Oral, 15 mg, Weekly, 48 weeks Adalimumab: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks | |||||||
All Cause Mortality |
||||||||||||||
| Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX | ||||||||
| 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 | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX | ||||||||
| 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 | 2/61 (3.3%) | 5/59 (8.5%) | 5/60 (8.3%) | 5/60 (8.3%) | 8/59 (13.6%) | 5/60 (8.3%) | 3/59 (5.1%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Neutropenia | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Cardiac disorders | ||||||||||||||
| Acute coronary syndrome | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Atrial fibrillation | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Coronary artery disease | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Mitral valve incompetence | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Eye disorders | ||||||||||||||
| Cataract | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Abdominal wall haematoma | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Diarrhoea | 1/61 (1.6%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Hepatobiliary disorders | ||||||||||||||
| Cholelithiasis | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Infections and infestations | ||||||||||||||
| Appendicitis | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 2/60 (3.3%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Cellulitis | 0/61 (0%) | 2/59 (3.4%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Pneumonia | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 1/59 (1.7%) | |||||||
| Pulmonary tuberculosis | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Atypical pneumonia | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Bursitis infective | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Herpes zoster | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 1/59 (1.7%) | |||||||
| Infective tenosynovitis | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Influenza | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Pneumocystis jiroveci pneumonia | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Sepsis | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Urinary tract infection | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Traumatic haematoma | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Overdose | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/60 (0%) | 3/59 (5.1%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Foot fracture | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Humerus fracture | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Medication error | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Investigations | ||||||||||||||
| Alanine aminotransferase increased | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Aspartate aminotransferase increased | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 1/61 (1.6%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Psychiatric disorders | ||||||||||||||
| Depression | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 1/59 (1.7%) | |||||||
| Suicide attempt | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Renal and urinary disorders | ||||||||||||||
| Tubulointerstitial nephritis | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 1/59 (1.7%) | |||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Interstitial lung disease | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Lung disorder | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Deep vein thrombosis | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Hypertension | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/59 (0%) | |||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo+MTX | Clazakizumab(25)+MTX | Clazakizumab(100) | Clazakizumab(100)+MTX | Clazakizumab(200) | Clazakizumab(200)+MTX | ADA+MTX | ||||||||
| 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 | 24/61 (39.3%) | 43/59 (72.9%) | 43/60 (71.7%) | 51/60 (85%) | 43/59 (72.9%) | 50/60 (83.3%) | 35/59 (59.3%) | |||||||
| Blood and lymphatic system disorders | ||||||||||||||
| Neutropenia | 0/61 (0%) | 2/59 (3.4%) | 4/60 (6.7%) | 2/60 (3.3%) | 4/59 (6.8%) | 1/60 (1.7%) | 2/59 (3.4%) | |||||||
| Leukopenia | 1/61 (1.6%) | 0/59 (0%) | 3/60 (5%) | 2/60 (3.3%) | 4/59 (6.8%) | 3/60 (5%) | 0/59 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Diarrhoea | 1/61 (1.6%) | 3/59 (5.1%) | 1/60 (1.7%) | 3/60 (5%) | 2/59 (3.4%) | 3/60 (5%) | 6/59 (10.2%) | |||||||
| Nausea | 1/61 (1.6%) | 3/59 (5.1%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 2/60 (3.3%) | 3/59 (5.1%) | |||||||
| Dyspepsia | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 1/60 (1.7%) | 1/59 (1.7%) | 0/60 (0%) | 3/59 (5.1%) | |||||||
| General disorders | ||||||||||||||
| Injection site reaction | 0/61 (0%) | 8/59 (13.6%) | 9/60 (15%) | 11/60 (18.3%) | 14/59 (23.7%) | 9/60 (15%) | 1/59 (1.7%) | |||||||
| Ejection site erythema | 0/61 (0%) | 2/59 (3.4%) | 8/60 (13.3%) | 15/60 (25%) | 10/59 (16.9%) | 9/60 (15%) | 2/59 (3.4%) | |||||||
| Injection site rash | 0/61 (0%) | 1/59 (1.7%) | 8/60 (13.3%) | 8/60 (13.3%) | 2/59 (3.4%) | 8/60 (13.3%) | 0/59 (0%) | |||||||
| Injection site dermatitis | 0/61 (0%) | 4/59 (6.8%) | 3/60 (5%) | 4/60 (6.7%) | 4/59 (6.8%) | 7/60 (11.7%) | 0/59 (0%) | |||||||
| Asthenia | 2/61 (3.3%) | 1/59 (1.7%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 3/60 (5%) | 1/59 (1.7%) | |||||||
| Injection site hypersensitivity | 0/61 (0%) | 0/59 (0%) | 3/60 (5%) | 2/60 (3.3%) | 2/59 (3.4%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Injection site papule | 0/61 (0%) | 1/59 (1.7%) | 2/60 (3.3%) | 0/60 (0%) | 1/59 (1.7%) | 3/60 (5%) | 0/59 (0%) | |||||||
| Injection site pruritis | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 4/60 (6.7%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Injection site macule | 0/61 (0%) | 0/59 (0%) | 1/60 (1.7%) | 0/60 (0%) | 1/59 (1.7%) | 3/60 (5%) | 0/59 (0%) | |||||||
| Injection site pain | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 1/60 (1.7%) | 3/59 (5.1%) | |||||||
| Infections and infestations | ||||||||||||||
| Nasopharyngitis | 4/61 (6.6%) | 2/59 (3.4%) | 3/60 (5%) | 4/60 (6.7%) | 3/59 (5.1%) | 7/60 (11.7%) | 2/59 (3.4%) | |||||||
| Upper respiraory tract infection | 7/61 (11.5%) | 5/59 (8.5%) | 1/60 (1.7%) | 3/60 (5%) | 7/59 (11.9%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Pharyngitis | 5/61 (8.2%) | 2/59 (3.4%) | 3/60 (5%) | 3/60 (5%) | 3/59 (5.1%) | 3/60 (5%) | 3/59 (5.1%) | |||||||
| Urinary tract infection | 4/61 (6.6%) | 5/59 (8.5%) | 1/60 (1.7%) | 2/60 (3.3%) | 2/59 (3.4%) | 5/60 (8.3%) | 1/59 (1.7%) | |||||||
| Bronchitis | 0/61 (0%) | 1/59 (1.7%) | 2/60 (3.3%) | 0/60 (0%) | 2/59 (3.4%) | 2/60 (3.3%) | 3/59 (5.1%) | |||||||
| Herpes zoster | 0/61 (0%) | 1/59 (1.7%) | 1/60 (1.7%) | 1/60 (1.7%) | 3/59 (5.1%) | 0/60 (0%) | 3/59 (5.1%) | |||||||
| Injury, poisoning and procedural complications | ||||||||||||||
| Arthropod bite | 0/61 (0%) | 0/59 (0%) | 3/60 (5%) | 1/60 (1.7%) | 0/59 (0%) | 1/60 (1.7%) | 0/59 (0%) | |||||||
| Overdose | 0/61 (0%) | 1/59 (1.7%) | 0/60 (0%) | 0/60 (0%) | 3/59 (5.1%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Investigations | ||||||||||||||
| Alanine aminotransferase increased | 2/61 (3.3%) | 11/59 (18.6%) | 2/60 (3.3%) | 13/60 (21.7%) | 1/59 (1.7%) | 18/60 (30%) | 3/59 (5.1%) | |||||||
| Aspartate aminotransferase increased | 0/61 (0%) | 8/59 (13.6%) | 0/60 (0%) | 14/60 (23.3%) | 0/59 (0%) | 12/60 (20%) | 2/59 (3.4%) | |||||||
| Gamma-glutamyltransferease increased | 1/61 (1.6%) | 0/59 (0%) | 2/60 (3.3%) | 4/60 (6.7%) | 0/59 (0%) | 2/60 (3.3%) | 2/59 (3.4%) | |||||||
| Metabolism and nutrition disorders | ||||||||||||||
| Hypercholesterolaemia | 2/61 (3.3%) | 7/59 (11.9%) | 7/60 (11.7%) | 5/60 (8.3%) | 5/59 (8.5%) | 9/60 (15%) | 2/59 (3.4%) | |||||||
| Dyslipidaemia | 1/61 (1.6%) | 7/59 (11.9%) | 4/60 (6.7%) | 2/60 (3.3%) | 2/59 (3.4%) | 4/60 (6.7%) | 1/59 (1.7%) | |||||||
| Hypertriglyceridaemia | 2/61 (3.3%) | 1/59 (1.7%) | 1/60 (1.7%) | 2/60 (3.3%) | 1/59 (1.7%) | 1/60 (1.7%) | 3/59 (5.1%) | |||||||
| Hyperlipidaemia | 0/61 (0%) | 3/59 (5.1%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 1/60 (1.7%) | 2/59 (3.4%) | |||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Muscle spasms | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 1/60 (1.7%) | 0/59 (0%) | 1/60 (1.7%) | 4/59 (6.8%) | |||||||
| Nervous system disorders | ||||||||||||||
| Headache | 5/61 (8.2%) | 2/59 (3.4%) | 0/60 (0%) | 0/60 (0%) | 1/59 (1.7%) | 2/60 (3.3%) | 1/59 (1.7%) | |||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Dermatitis allergic | 0/61 (0%) | 0/59 (0%) | 3/60 (5%) | 0/60 (0%) | 0/59 (0%) | 0/60 (0%) | 0/59 (0%) | |||||||
| Skin lesion | 0/61 (0%) | 0/59 (0%) | 0/60 (0%) | 0/60 (0%) | 0/59 (0%) | 3/60 (5%) | 0/59 (0%) | |||||||
| Vascular disorders | ||||||||||||||
| Hypertension | 1/61 (1.6%) | 0/59 (0%) | 1/60 (1.7%) | 4/60 (6.7%) | 6/59 (10.2%) | 2/60 (3.3%) | 2/59 (3.4%) | |||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | CSL Behring |
| Phone | 610-878-4000 |
| clinicaltrials@cslbehring.com |
Responsible Party:
CSL Behring
ClinicalTrials.gov Identifier:
NCT01373151
Other Study ID Numbers:
- IM133-001
- 2010-023956-99
First Posted:
Jun 14, 2011
Last Update Posted:
Dec 6, 2021
Last Verified:
Nov 1, 2021