Clinical trial NCT02015520: Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
Official title: A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 143
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 primary purpose of this study is to identify an appropriate dose of study medication.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American Rheumatism association (ARA) \[1987\] or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) \[2010\]) at least 16 weeks prior to screening
* ACR global functional status class of 1 to 3
* Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors
* All subjects must have been receiving treatment with a minimum dose of 15 mg per week of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is permitted, if it is at a dose approved for the treatment of RA and the dose has been stable for at least 28 days prior to screening
* Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at baseline (Day 1)
* Elevated High-sensitivity (hs) CRP and/or ESR

Exclusion Criteria:

* Active serious infection
* History of or active tuberculosis (TB)
* Elevated liver function tests (LFTs)

Primary outcomes:
measure: Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: American College of Rheumatology (ACR) 20/50/70 Response Rates
timeFrame: At week 12
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
timeFrame: Baseline and week 12
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
timeFrame: Baseline and week 12
measure: Boolean Remission at Week 12
timeFrame: At week 12
measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline and Week 12
measure: Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6
timeFrame: At week 12
measure: Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6
timeFrame: At week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Hot Springs
country: United States
facility: Mercy Clinic Hot Springs Communities
state: Arkansas
city: Long Beach
country: United States
facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Center For Rheumatology
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Charlotte
country: United States
facility: Joint And Muscle Medical Care And Research Institute (Jmmcri)
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, Pa
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, Llc
state: Ohio
city: Oklahoma City
country: United States
facility: Arthritis & Rheumatology Center Of Oklahoma Pllc
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Charleston
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Knoxville
country: United States
facility: Rheumatology Consultants Pllc
state: Tennessee
city: Nashville
country: United States
facility: Center For Inflammatory Disease
state: Tennessee
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Quilmes
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Tucuman
country: Argentina
facility: Local Institution
city: Hamilton
country: Canada
facility: Cividino Medicine Professional Corporation
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Rheumatology
state: Ontario
city: Saskatoon
country: Canada
facility: Dr. Latha Naik Medical Professional Corporation
state: Saskatchewan
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Poitiers
country: France
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: Catanzaro
country: Italy
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kato-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Nagano-shi
country: Japan
facility: Local Institution
state: Nagano
city: Sasebo-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Toshima-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Nishimura
country: Japan
facility: Local Institution
state: Wakayama
city: Tijuana
country: Mexico
facility: Local Institution
state: Baja California
city: Leon
country: Mexico
facility: Local Institution
state: Guanajuato
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Guadalajara
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Stellenbosch
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: