Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01490450
Registration number
NCT01490450
Ethics application status
Date submitted
14/11/2011
Date registered
13/12/2011
Date last updated
5/11/2021
Titles & IDs
Public 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
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2011-004016-29
Query!
Secondary ID [2]
0
0
IM133-004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - Placebo matching BMS-945429
Other interventions - BMS-945429
Other interventions - BMS-945429
Other interventions - BMS-945429
Placebo Comparator: PBO: Placebo matching BMS-945429 -
Experimental: BMS-945429 (25mg) -
Experimental: BMS-945429 (100mg) -
Experimental: BMS-945429 (200mg) -
Other interventions: Placebo matching BMS-945429
Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Other interventions: BMS-945429
Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Other interventions: BMS-945429
Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Other interventions: BMS-945429
Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
At 16 weeks
Query!
Secondary outcome [1]
0
0
Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 16 and Week 24
Query!
Secondary outcome [2]
0
0
Percent of Participants Achieving ACR50 and ACR70 Response Rate
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
Week 16 and Week 24
Query!
Secondary outcome [3]
0
0
Percent of Participants Achieving ACR20 Response Rate at Week 24
Query!
Assessment method [3]
0
0
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).
Query!
Timepoint [3]
0
0
Week 24
Query!
Secondary outcome [4]
0
0
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Weeks 16 and Week 24
Query!
Secondary outcome [5]
0
0
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline and Week 16
Query!
Secondary outcome [6]
0
0
Mean Change From Baseline at Week 24 in SF-36 Scores
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline and Week 24
Query!
Secondary outcome [7]
0
0
Number of Participants With Anti-clazakizumab Antibodies
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Up to 24 weeks
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Previously received or currently receiving concomitant biologic therapy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/06/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
165
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Cairns
Query!
Recruitment hospital [2]
0
0
Local Institution - Maroochydore
Query!
Recruitment hospital [3]
0
0
Local Institution - Woodville
Query!
Recruitment hospital [4]
0
0
Local Institution - Shenton Park
Query!
Recruitment postcode(s) [1]
0
0
4870 - Cairns
Query!
Recruitment postcode(s) [2]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [3]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [4]
0
0
6008 - Shenton Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Mississippi
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
North Carolina
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Oklahoma
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Pennsylvania
Query!
Country [9]
0
0
Argentina
Query!
State/province [9]
0
0
Buenos Aires
Query!
Country [10]
0
0
Argentina
Query!
State/province [10]
0
0
Tucuman
Query!
Country [11]
0
0
Canada
Query!
State/province [11]
0
0
Manitoba
Query!
Country [12]
0
0
Canada
Query!
State/province [12]
0
0
Quebec
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Pardubice
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Praha 2
Query!
Country [15]
0
0
Germany
Query!
State/province [15]
0
0
Bad Nauheim
Query!
Country [16]
0
0
Germany
Query!
State/province [16]
0
0
Erlangen
Query!
Country [17]
0
0
Germany
Query!
State/province [17]
0
0
Planegg
Query!
Country [18]
0
0
Hungary
Query!
State/province [18]
0
0
Budapest
Query!
Country [19]
0
0
Hungary
Query!
State/province [19]
0
0
Debrecen
Query!
Country [20]
0
0
Hungary
Query!
State/province [20]
0
0
Veszprem
Query!
Country [21]
0
0
Italy
Query!
State/province [21]
0
0
Firenze
Query!
Country [22]
0
0
Italy
Query!
State/province [22]
0
0
Napoli
Query!
Country [23]
0
0
Mexico
Query!
State/province [23]
0
0
Aguascalientes
Query!
Country [24]
0
0
Mexico
Query!
State/province [24]
0
0
Jalisco
Query!
Country [25]
0
0
Mexico
Query!
State/province [25]
0
0
Nuevo Leon
Query!
Country [26]
0
0
Poland
Query!
State/province [26]
0
0
Bialystok
Query!
Country [27]
0
0
Poland
Query!
State/province [27]
0
0
Dabrowka
Query!
Country [28]
0
0
Poland
Query!
State/province [28]
0
0
Elblag
Query!
Country [29]
0
0
Poland
Query!
State/province [29]
0
0
Poznan
Query!
Country [30]
0
0
Poland
Query!
State/province [30]
0
0
Warszawa
Query!
Country [31]
0
0
Russian Federation
Query!
State/province [31]
0
0
Moscow
Query!
Country [32]
0
0
Russian Federation
Query!
State/province [32]
0
0
Yaroslavl
Query!
Country [33]
0
0
South Africa
Query!
State/province [33]
0
0
Gauteng
Query!
Country [34]
0
0
South Africa
Query!
State/province [34]
0
0
KWA ZULU Natal
Query!
Country [35]
0
0
South Africa
Query!
State/province [35]
0
0
Western CAPE
Query!
Country [36]
0
0
South Africa
Query!
State/province [36]
0
0
Western Cape
Query!
Country [37]
0
0
Spain
Query!
State/province [37]
0
0
A Coruna
Query!
Country [38]
0
0
Spain
Query!
State/province [38]
0
0
Barcelona
Query!
Country [39]
0
0
Spain
Query!
State/province [39]
0
0
Sevilla
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
CSL Behring
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01490450
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01490450
Download to PDF