Clinical trial NCT01490450: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Psoriatic
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2011-12-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percent of Participants Achieving American College of Rheumatology Criteria 20% Response Rate (ACR20)
timeFrame: At 16 weeks
Secondary outcomes:
measure: Percent of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response Rate
timeFrame: Week 16 and Week 24
measure: Percent of Participants Achieving ACR50 and ACR70 Response Rate
timeFrame: Week 16 and Week 24
measure: Percent of Participants Achieving ACR20 Response Rate at Week 24
timeFrame: Week 24
measure: Percent of Participants Achieving a Health Assessment Questionnaire (HAQ) Response
timeFrame: Weeks 16 and Week 24
measure: Mean Change From Baseline at Week 16 in Short Form (36) [SF-36] Scores
timeFrame: Baseline and Week 16
measure: Mean Change From Baseline at Week 24 in SF-36 Scores
timeFrame: Baseline and Week 24
measure: Number of Participants With Anti-clazakizumab Antibodies
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates, Llc
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Jackson
country: United States
facility: Arthritis Associates Of Mississippi
state: Mississippi
city: Charlotte
country: United States
facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, P.C.
state: Pennsylvania
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Tucuman
country: Argentina
facility: Local Institution
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Maroochydore
country: Australia
facility: Local Institution
state: Queensland
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Shenton Park
country: Australia
facility: Local Institution
state: Western Australia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Rimouski
country: Canada
facility: Centre De Rhumatologie De L Est Du Quebec
state: Quebec
city: Trois-rivieres
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Pardubice
country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Bad Nauheim
country: Germany
facility: Local Institution
city: Erlangen
country: Germany
facility: Local Institution
city: Planegg
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Veszprem
country: Hungary
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Aguascalientes
city: Zapopan
country: Mexico
facility: Local Institution
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Bialystok
country: Poland
facility: Local Institution
city: Dabrowka
country: Poland
facility: Local Institution
city: Elblag
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: KWA ZULU Natal
city: Panorama, Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Pinelands, Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: A Coruna
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.