RHEUMATOID ARTHRITIS,NOS MedDRA version: 17.1 Level: LLT Classification code 10039076 Term: Rheumatoid arthritis and other inflammatory polyarthropathies System Organ Class: 100000004859
Conditions
Interventions
Product Name: CLAZAKIZUMAB
Product Code: BMS-945429
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CLAZAKIZUMAB
Current Sponsor code: BMS-945429
Other descriptive name: anti-IL-6 mAb
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Inadequate response to methotrexate • Must have been taking methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization • ACR global function status class 1-3 • Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist • hsCRP >/= 0.8 mg/dL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 476 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 201
Exclusion criteria
Exclusion criteria: • Previously received or currently receiving concomitant biologic therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to methotrexate in the treatment of moderate to severe Rheumatoid Arthritis;Secondary Objective: ACR 50 ACR 70 Disease Activity Score-c Reactive Protein (DAS-CRP) Clinical Disease Activity Index Physical Function Magnetic Resonance Imaging (MRI) X-Ray Health Related Quality of Life outcomes Safety (number of adverse events);Primary end point(s): Proportion of subjects achieving an ACR 20 response rate;Timepoint(s) of evaluation of this end point: At 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of subjects with ACR 20 response - Proportion of subjects achieving ACR 50 response rate - Proportion of subjects achieving ACR 70 response rate - Mean change from baseline in disease activity as measured by DAS28- CRP - Proportion of subjects with remission by DAS28-CRP - Mean change from baseline in CDAI - Proportion of subjects with remission by CDAI - Mean change from baseline in SDAI - Proportion of subjects with remission by SDAI - Proportion of subjects with remission rate by Boolean definition - Mean change from baseline in HAQ disability Index - Mean change from baseline in SF-36 as measured by physical and mental components as well as 8 individual domain scores - Mean change from baseline in fatigue severity (VAS) - Mean change from baseline in WPAI as measured by 4 domain scores - Mean change from baseline in radiographic progression of synovitis, osteitis (bone marrow edema), bone erosion and cartilage loss (jointspace narrowing) (MRI) - Mean change from baseline in radiographic progression of joint damage as measured by modified Sharp/van der Heijide scores (X-ray) - Safety will be measured by adverse events, clinically significant changes in vital signs, physical exams and ECG, laboratory test abnormality and immunogenicity changes from baseline;Timepoint(s) of evaluation of this end point: - At week 24 - At weeks 12 and 24 - At weeks 12 and 24 - To weeks 12 and 24 - At weeks 12 and 24 - At weeks 12 and 24 - At weeks 12 and 24 - At weeks 12 and 24 - At weeks 12 and 24 - At weeks 12 and 24 - To weeks 12 and 24 - To weeks 12 and 24 - To weeks 12 and 24 - To weeks 12 and 24 - To week 12 - To week 24 - Over the double-blind period (48 weeks) | — |
Countries
Argentina, Belgium, Brazil, Canada, Czech Republic, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Peru, Russian Federation, South Africa, Spain, Taiwan, United States
Contacts
Public ContactEU Start Up Department
Bristol-Myers Squibb International Corporation
Outcome results
None listed