Back to resultsPsoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Primary Purpose
Arthritis, Psoriatic
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo matching BMS-945429
BMS-945429
BMS-945429
BMS-945429
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Psoriatic
Eligibility Criteria
Inclusion Criteria:
- Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
- Inadequate response to NSAID and/or non-biologic DMARD
- Minimum of 3 swollen and 3 tender joints
- Active psoriatic skin lesions over minimum 3% body surface area
- high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL
Exclusion Criteria:
- Previously received or currently receiving concomitant biologic therapy
Sites / Locations
- San Diego Arthritis Medical Clinic
- Denver Arthritis Clinic
- New England Research Associates, Llc
- Sarasota Arthritis Research Center
- Arthritis Associates Of Mississippi
- Box Arthritis And Rheumatology Of The Carolinas, Pllc
- Health Research Of Oklahoma
- East Penn Rheumatology Associates, P.C.
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Manitoba Clinic
- Local Institution
- Centre De Rhumatologie De L Est Du Quebec
- Centre De Recherche Musculo-Squelettique
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
PBO: Placebo matching BMS-945429
BMS-945429 (25mg)
BMS-945429 (100mg)
BMS-945429 (200mg)
Arm Description
Outcomes
Primary Outcome Measures
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
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 Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.
These grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.
PASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.
Percent of Participants Achieving ACR50 and ACR70 Response Rate
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 ACR20 Response Rate at Week 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 a Health Assessment Questionnaire (HAQ) Response
For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3).
Response is measured by a reduction of at least 0.3 unit from baseline in HAQ index.
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
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 at Week 24 in SF-36 Scores
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.
Number of Participants With Anti-clazakizumab Antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01490450
Brief Title
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
Official Title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging, Multi-Center Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection in Adults With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic Disease modifying anti-rheumatic drugs (DMARDs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PBO: Placebo matching BMS-945429
Arm Type
Placebo Comparator
Arm Title
BMS-945429 (25mg)
Arm Type
Experimental
Arm Title
BMS-945429 (100mg)
Arm Type
Experimental
Arm Title
BMS-945429 (200mg)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo matching BMS-945429
Intervention Description
Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Primary Outcome Measure Information:
Title
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
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 16 weeks
Secondary Outcome Measure Information:
Title
Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
Description
To calculate the PASI score, the psoriasis plaques found on each body region are graded for their combined redness, thickness, and scaliness. The severity of the plaques in each region is graded on a 0 to 4 scale, with 0 meaning no involvement and 4 meaning severe involvement. Next, the amount of surface area on each body region that is covered by the plaques is calculated. The total surface area affected by psoriasis is graded from 0 to 6, with 0 meaning no involvement and 6 meaning greater than 90 percent of the region covered in plaques.
These grades are then fed into an equation to determine the patient's PASI score. The PASI score then is used as a clinical assessment of the patient's psoriasis involvement. A person free of psoriasis has a score of 0 and the score could be as high as 72.
PASI 75 means that the person's PASI score dropped by 75 percent as a result of the psoriasis treatment.
Time Frame
Week 16 and Week 24
Title
Percent of Participants Achieving ACR50 and ACR70 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
Week 16 and Week 24
Title
Percent of Participants Achieving ACR20 Response Rate at Week 24
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
Week 24
Title
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
Description
For each item, there is a four-level difficulty scale that is scored from 0 to 3, representing normal (no difficulty) (0), some difficulty (1), much difficulty (2), and unable to do (3). There are 20 questions in eight categories of functioning - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The highest component score in each category determines the score for the category, unless aids or devices are required. Dependence on equipment or physical assistance increases a lower score to the level of 2 to more accurately represent underlying disability. The eight category scores are averaged into an overall HAQ score on a scale from zero (no disability) to three (completely disabled). The scale is not truly continuous but has 25 possible values (i.e., 0, 0.125, 0.250, 0.375 … 3).
Response is measured by a reduction of at least 0.3 unit from baseline in HAQ index.
Time Frame
Weeks 16 and Week 24
Title
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
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 and Week 16
Title
Mean Change From Baseline at Week 24 in SF-36 Scores
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 and Week 24
Title
Number of Participants With Anti-clazakizumab Antibodies
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must be on a stable background Methotrexate (MTX) therapy prior to Day1/Randomization. Subjects must have taken MTX for at least 3 months at a dose ≥ 15 mg/week to a maximum weekly dose of ≤ 25 mg/week, and be at a stable dose for 4 weeks prior to randomization (Day 1). Methotrexate dose ≥ 15 mg/week that was not efficacious and that was decreased due to toxicity as low as 10 mg/week is allowed
Inadequate response to NSAID and/or non-biologic DMARD
Minimum of 3 swollen and 3 tender joints
Active psoriatic skin lesions over minimum 3% body surface area
high sensitivity C-reactive protein (hsCRP) ≥ 0.3 mg/dL
Exclusion Criteria:
Previously received or currently receiving concomitant biologic therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
San Diego Arthritis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates, Llc
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Arthritis Associates Of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Box Arthritis And Rheumatology Of The Carolinas, Pllc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Health Research Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
East Penn Rheumatology Associates, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Local Institution
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Local Institution
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Local Institution
City
Shenton Park
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Manitoba Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre De Rhumatologie De L Est Du Quebec
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
Facility Name
Centre De Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Local Institution
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Local Institution
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Local Institution
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Mexico
State/Province
Aguascalientes
ZIP/Postal Code
20127
Country
Mexico
Facility Name
Local Institution
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45190
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Local Institution
City
Dabrowka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Local Institution
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60773
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
KWA ZULU Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Panorama, Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Pinelands, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
27059799
Citation
Mease PJ, Gottlieb AB, Berman A, Drescher E, Xing J, Wong R, Banerjee S. The Efficacy and Safety of Clazakizumab, an Anti-Interleukin-6 Monoclonal Antibody, in a Phase IIb Study of Adults With Active Psoriatic Arthritis. Arthritis Rheumatol. 2016 Sep;68(9):2163-73. doi: 10.1002/art.39700.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
We'll reach out to this number within 24 hrs