Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01490450




Trial ID
NCT01490450
Ethics application status
Date submitted
14/11/2011
Date registered
9/12/2011
Date last updated
13/09/2017

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
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
Secondary ID [1] 0 0
2011-004016-29
Secondary ID [2] 0 0
IM133-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Psoriatic 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
American College of Rheumatology criteria (ACR20) - 20% ACR response
Timepoint [1] 0 0
At 16 weeks
Secondary outcome [1] 0 0
Proportion of subjects achieving Psoriasis Area Severity Index (PASI) 75 response rate
Timepoint [1] 0 0
Week 16 and Week 24
Secondary outcome [2] 0 0
Proportion of subjects achieving ACR50 and ACR70 response rate - 50% and 70 % ACR response
Timepoint [2] 0 0
Week 16 and Week 24
Secondary outcome [3] 0 0
Proportion of subjects achieving ACR20 response rate
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Proportion of subjects achieving a Health Assessment Questionnaire (HAQ) response - As measured by a reduction of at least 0.3 unit from baseline in HAQ index
Timepoint [4] 0 0
Weeks 16 and Week 24
Secondary outcome [5] 0 0
Short Form (36) [SF-36] changes from baseline
Timepoint [5] 0 0
Baseline (Day 1) and Week 16
Secondary outcome [6] 0 0
Short Form (36) [SF-36] changes from baseline
Timepoint [6] 0 0
Baseline (Day 1) and Week 24
Secondary outcome [7] 0 0
Safety and tolerability as measured by adverse events (AEs), vital signs, physical examinations and safety lab values
Timepoint [7] 0 0
24 Weeks (during double-blind period)
Secondary outcome [8] 0 0
Immunogenicity as measured by anti-BMS-945429 antibodies levels in serum
Timepoint [8] 0 0
24 Weeks (during double-blind period)

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previously received or currently receiving concomitant biologic therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Local Institution - Cairns
Recruitment hospital [2] 0 0
Local Institution - Maroochydore
Recruitment hospital [3] 0 0
Local Institution - Woodville
Recruitment hospital [4] 0 0
Local Institution - Shenton Park
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
5011 - Woodville
Recruitment postcode(s) [4] 0 0
6008 - Shenton Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Mississippi
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Oklahoma
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Tucuman
Country [11] 0 0
Canada
State/province [11] 0 0
Manitoba
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Czechia
State/province [13] 0 0
Pardubice
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 2
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Nauheim
Country [16] 0 0
Germany
State/province [16] 0 0
Erlangen
Country [17] 0 0
Germany
State/province [17] 0 0
Planegg
Country [18] 0 0
Hungary
State/province [18] 0 0
Budapest
Country [19] 0 0
Hungary
State/province [19] 0 0
Debrecen
Country [20] 0 0
Hungary
State/province [20] 0 0
Veszprem
Country [21] 0 0
Italy
State/province [21] 0 0
Firenze
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Mexico
State/province [23] 0 0
Aguascalientes
Country [24] 0 0
Mexico
State/province [24] 0 0
Jalisco
Country [25] 0 0
Mexico
State/province [25] 0 0
Nuevo Leon
Country [26] 0 0
Poland
State/province [26] 0 0
Bialystok
Country [27] 0 0
Poland
State/province [27] 0 0
Dabrowka
Country [28] 0 0
Poland
State/province [28] 0 0
Elblag
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Poland
State/province [30] 0 0
Warszawa
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Moscow
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Yaroslavl
Country [33] 0 0
South Africa
State/province [33] 0 0
Gauteng
Country [34] 0 0
South Africa
State/province [34] 0 0
Kwa Zulu Natal
Country [35] 0 0
South Africa
State/province [35] 0 0
Western Cape
Country [36] 0 0
Spain
State/province [36] 0 0
A Coruna
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vitaeris INC
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01490450
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries