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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Treatment: Other - Placebo matching BMS-945429
Treatment: Other - BMS-945429
Treatment: Other - BMS-945429
Treatment: Other - BMS-945429

Placebo comparator: PBO: Placebo matching BMS-945429 -

Experimental: BMS-945429 (25mg) -

Experimental: BMS-945429 (100mg) -

Experimental: BMS-945429 (200mg) -


Treatment: Other: Placebo matching BMS-945429
Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Treatment: Other: BMS-945429
Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Treatment: Other: BMS-945429
Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label

Treatment: Other: 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
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
Timepoint [1] 0 0
At 16 weeks
Secondary outcome [1] 0 0
Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
Timepoint [1] 0 0
Week 16 and Week 24
Secondary outcome [2] 0 0
Percent of Participants Achieving ACR50 and ACR70 Response Rate
Timepoint [2] 0 0
Week 16 and Week 24
Secondary outcome [3] 0 0
Percent of Participants Achieving ACR20 Response Rate at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
Timepoint [4] 0 0
Weeks 16 and Week 24
Secondary outcome [5] 0 0
Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
Mean Change From Baseline at Week 24 in SF-36 Scores
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Number of Participants With Anti-clazakizumab Antibodies
Timepoint [7] 0 0
Up to 24 weeks

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
Sex
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
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
165
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
South Africa
State/province [36] 0 0
Western Cape
Country [37] 0 0
Spain
State/province [37] 0 0
A Coruna
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CSL Behring
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/study/NCT01490450
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01490450