A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous (SC) Tocilizumab (TCZ) With MTX
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01855789
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (\</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score \</=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 718
- Body weight </=150 kg
- Active moderate to severe rheumatoid arthritis (DAS28 >/=4.4) according to the revised 1987 ACR criteria at screening and baseline (prior to treatment on Day 1)
- Currently receiving oral MTX for at least 24 weeks and on a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1), with the following exception: a stable dose of at least 10 mg/week is allowed for participants with a body weight <50 kg or calculated glomerular filtration rate (or creatinine clearance) <60 milliliters per minute (mL/min)
- History of parenteral (SC or intramuscular [IM]) MTX is allowed, but not within 6 weeks prior to treatment (Day 1). Participants must not have a documented, clinically significant intolerance to oral MTX and must be receiving oral MTX at a dose of 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- Participants who have received one prior anti-tumor necrosis factor (TNF) must have discontinued etanercept, infliximab, certolizumab, adalimumab, or golimumab for at least 6 months prior to screening
- Oral corticosteroids must have been </=10 mg/day prednisone (or equivalent) and stable for at least 25 out of 28 days prior to treatment (Day 1)
- Participants receiving treatment on an outpatient basis
- Documented medical history of significant intolerance to oral MTX >/=15 mg/week
- Participants receiving other (non-MTX) disease modifying anti-rheumatic drugs (DMARDs) within 8 weeks of screening
- Previous treatment with abatacept, rituximab, tofacitinib, or anakinra
- Treatment with parenteral corticosteroids within 4 weeks prior to treatment
- Previous treatment with cell-depleting therapies or alkylating agents
- Previous treatment with TCZ
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Non-rheumatic active autoimmune diseases (for example, inflammatory bowel diseases, psoriasis, multiple sclerosis)
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Functional Class IV according to the revised (1987) ACR criteria for rheumatoid arthritis
- History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Evidence of significant uncontrolled concomitant diseases; uncontrolled disease states where flares are commonly treated with oral or parenteral corticosteroids
- Active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening
- Active tuberculosis requiring treatment within the previous 3 years
- History of or currently active primary or secondary immunodeficiency
- Pregnant or breast-feeding women
- Positive for hepatitis B or hepatitis C infection
- For potential MRI substudy participants: the presence of any metal-containing device or object in the body
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Randomized Participants (TCZ + MTX) Tocilizumab (TCZ) All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score \</=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52. Randomized Participants (TCZ + MTX) Tocilizumab (TCZ) Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52. Non-Randomized Participants (TCZ + MTX) Methotrexate (MTX) All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score \</=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52. Randomized Participants (TCZ + MTX) Methotrexate (MTX) Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52. Randomized Participants (TCZ + PBO) Tocilizumab (TCZ) Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52. Randomized Participants (TCZ + PBO) Placebo (PBO) Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.
- Primary Outcome Measures
Name Time Method Change From Week 24 in Disease Activity Score Based on 28 Joints (DAS28) Score at Week 40 Week 24, Week 40 The DAS28 was derived from assessments of erythrocyte sedimentation rate (ESR) measured in millimeters per hour (mm/h), tender joint count on 28 joints (TJC28), swollen joint count on 28 joints (SJC28), and Patient's Global Assessment of disease activity according to 100--millimeter (mm) Visual Analog Scale (VAS). DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity. The change from Week 24 to Week 40 was averaged among all participants, where negative changes indicated an improvement in disease activity.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving 70% Improvement in American College of Rheumatology (ACR70) Response Weeks 24, 40, and 52 The ACR70 response at any time was defined as \>/=70% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 70% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Percentage of Participants With DAS28 Score </=3.2 (Low DAS28) Week 40, Week 52 The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28-ESR score could range from 0 to 10, where higher score represented higher disease activity.
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology (ACR20) Response Weeks 24, 40, and 52 The ACR20 response at any time was defined as \>/=20% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 20% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via a Health Assessment Questionnaire-Disability Index (HAQ-DI), and 5) Acute phase reactant (ESR in mm/h or C-Reactive Protein \[CRP\] in milligrams per deciliter \[mg/dL\]).
Change From Week 24 in Bone Erosion Score at Week 40 for Participants in the Magnetic Resonance Imaging (MRI) Substudy Weeks 24, Week 40 Bones from the wrist regions (carpal bones, distal radius, distal ulna, and metacarpal bases) and the metacarpophalangeal (MCP) joints (metacarpal heads and phalangeal bases) were assessed for erosion via MRI and scored separately based on the proportion of eroded bone compared to the 'assessed bone volume' judged from all available images. Scoring ranged from 0 (no erosion) to 10 (91-100%). Results were summed, resulting in scores from 0 to 80 for the wrist region, 0 to 150 for the MCP joints, and 0 to 230 on aggregate. A negative value for change from Week 24 in bone erosion score indicated an improvement.
Percentage of Participants Achieving 50% Improvement in American College of Rheumatology (ACR50) Response Weeks 24, 40, and 52 The ACR50 response at any time was defined as \>/=50% improvement compared to baseline in TJC (assessed on 68 joints) and SJC (assessed on 66 joints); and 50% improvement compared to baseline in 3 of the following 5 criteria, respectively: 1) Patient's global assessment of disease activity according to 100-mm VAS, 2) Physician's global assessment of disease activity according to 100-mm VAS, 3) participant's global assessment of pain according to 100-mm VAS, 4) Participant's assessment of functional ability via HAQ-DI, and 5) Acute phase reactant (ESR in mm/h or CRP in mg/dL).
Percentage of Participants With >/=1.2 Points Increase (Worsening) From Week 24 in DAS28 Score at Week 40 and 52 Week 24, 40, and 52 The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28- score could range from 0 to 10, where higher score represented higher disease activity.
Mean TCZ Serum Concentration Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60) Percentage of Participants With DAS28 Score <2.6 (DAS28 Remission) Week 40, Week 52 The DAS28 was derived from assessments of ESR measured in mm/h, TJC28, SJC28, and Patient's global assessment of disease activity according to 100-mm VAS. DAS28 score was calculated as \[0.56 × square root of TJC\] + \[0.28 × square root of SJC\] + \[0.70 × natural log (ESR)\] + \[0.014 × VAS\]. DAS28 score could range from 0 to 10, where higher score represented higher disease activity.
Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to TCZ Baseline, Post-baseline (assessed at Weeks 12, 24, 36, 52 and at follow up [Week 60]) Percentage of participants with positive results for ATA against TCZ at Baseline and at any of the post-baseline assessment time-points was reported. Participants positive at any post-baseline time points were participants who had no positivity at baseline for the same assay.
Mean Soluble Interleukin-6 (IL-6) Receptor Concentration Baseline, Weeks 12, 24, 36, 52 and follow up (Week 60)
Trial Locations
- Locations (154)
Phase Iii Clinical Research
🇺🇸Fall River, Massachusetts, United States
Fort Smith Rheumatology, PC
🇺🇸Fort Smith, Arkansas, United States
Joao Nascimento
🇺🇸Bridgeport, Connecticut, United States
Precision Research Organization
🇺🇸Miami Lakes, Florida, United States
Columbus Arthritis Center
🇺🇸Columbus, Ohio, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
New England Medical Center; Dept. of Medicine, Div. of Rheumatology
🇺🇸Boston, Massachusetts, United States
CHI St. Vincent Medical Group Hot Springs
🇺🇸Hot Springs, Arkansas, United States
CV Mehta MD Medical Corp
🇺🇸Hemet, California, United States
Arthritis & Osteoporosis Center Pc
🇺🇸Hamden, Connecticut, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Nisus Research/Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States
Advanced Rheumatology, PC
🇺🇸Lansing, Michigan, United States
St. Luke's Hospital Association of Duluth
🇺🇸Duluth, Minnesota, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
St. Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
Arthritis and Osteoporosis Associates of New Mexico
🇺🇸Las Cruces, New Mexico, United States
The Center for Rheumatology
🇺🇸Albany, New York, United States
Atlantic Coast Rheumatology
🇺🇸Toms River, New Jersey, United States
St. Jude Hospital Yorba Linda DBA St. Joseph
🇺🇸Fullerton, California, United States
Ocean Rheumatology
🇺🇸Toms River, New Jersey, United States
Manhattan Medical Reserach
🇺🇸New York, New York, United States
Shores Rheumatology
🇺🇸Saint Clair Shores, Michigan, United States
Clinical Pharmacology Study Group
🇺🇸Worcester, Massachusetts, United States
Clayton Medical Research
🇺🇸Saint Louis, Missouri, United States
Clinical Research Center of Ct/Ny
🇺🇸Danbury, Connecticut, United States
Manhasset Rheumatology
🇺🇸Manhasset, New York, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Amarillo Center For Clinical Research
🇺🇸Amarillo, Texas, United States
Rheumatology Research Group
🇺🇸Lebanon, New Hampshire, United States
Arthritis & Osteoporosis Center
🇺🇸Brooklyn, New York, United States
Buffalo Rheumatology Associates
🇺🇸Orchard Park, New York, United States
St. Alexius Medical Center; Arthritis Clinic
🇺🇸Bismarck, North Dakota, United States
Odyssey Research Services; Main Medical Building
🇺🇸Bismarck, North Dakota, United States
Ramesh Gupta - PP
🇺🇸Memphis, Tennessee, United States
Arthritis Associates
🇺🇸Erie, Pennsylvania, United States
Arthritis and Osteoporosis Associates
🇺🇸Manalapan, New Jersey, United States
Arthritis Care & Diagnostic Center
🇺🇸Dallas, Texas, United States
Advanced Rheumatology & Arthritis Research Center
🇺🇸Wexford, Pennsylvania, United States
Office of Premier Chatpar Md
🇺🇸Plainview, New York, United States
Paramount Medical Research
🇺🇸Middleburg Heights, Ohio, United States
Clinical Research Center of Reading
🇺🇸Wyomissing, Pennsylvania, United States
Crystal Arthritis Center, Inc.
🇺🇸Akron, Ohio, United States
Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
Adriana Pop-Moody MD Clinic PA
🇺🇸Corpus Christi, Texas, United States
Ohio State University; Rheumatology; Immun/Rheum
🇺🇸Columbus, Ohio, United States
Arthritis & Osteoporosis Clinic
🇺🇸Waco, Texas, United States
C Michael Neuwelt MD Inc
🇺🇸San Leandro, California, United States
Suncoast Research Group LLC
🇺🇸Miami, Florida, United States
South Coast Research Center, Inc.
🇺🇸Miami, Florida, United States
Indiana Uni Medical Center
🇺🇸Indianapolis, Indiana, United States
Diagnostic Rheumatology & Research
🇺🇸Indianapolis, Indiana, United States
G. T. Kelly, MD
🇺🇸Las Vegas, Nevada, United States
Triangle Orthopaedics Associates, P.A.
🇺🇸Durham, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
🇺🇸Cincinnati, Ohio, United States
Rheumatic Disease Clin Res Ctr
🇺🇸Houston, Texas, United States
IntraFusion Researh Network
🇺🇸Houston, Texas, United States
Accurate Clinical Research
🇺🇸Houston, Texas, United States
NextGen Clinical Research Inc
🇺🇸San Antonio, Texas, United States
Arthiritis & Osteoporosis Centre of South Texas
🇺🇸San Antonio, Texas, United States
Uni Of Alabama,Birmingham; Medicine - Rheumatology
🇺🇸Birmingham, Alabama, United States
Lynn Health Science Inst.
🇺🇸Oklahoma City, Oklahoma, United States
Arthritis and Rheumatology; Center of Oklahoma PLLC
🇺🇸Oklahoma City, Oklahoma, United States
Health Research of Oklahoma, Llc
🇺🇸Oklahoma City, Oklahoma, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
McIlwain Medical Group
🇺🇸Tampa, Florida, United States
Burnette & Silverfield, MDS
🇺🇸Tampa, Florida, United States
Cape Fear Arthritis Care
🇺🇸Leland, North Carolina, United States
Emkey Arthritis & Osteoporosis
🇺🇸Wyomissing, Pennsylvania, United States
Pinnacle Research Group; Llc, Central
🇺🇸Anniston, Alabama, United States
Clnical & Translational Reseach Center for Alabama, PC
🇺🇸Tuscaloosa, Alabama, United States
Arizona Arthritis & Rheumatology Associates, P.C.
🇺🇸Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, Pllc
🇺🇸Mesa, Arizona, United States
Rheumatology Associates of North Alabama
🇺🇸Huntsville, Alabama, United States
Valley Arthritis Care
🇺🇸Phoenix, Arizona, United States
Arizona Arthritis and Rheuma
🇺🇸Mesa, Arizona, United States
Advanced Arthritis Care & Research
🇺🇸Scottsdale, Arizona, United States
Little Rock Diagnostic Clinic
🇺🇸Little Rock, Arkansas, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Medvin Clinical Research
🇺🇸Whittier, California, United States
San Diego Arthritis Med Clnc
🇺🇸San Diego, California, United States
NRC Research Institute
🇺🇸Orange, California, United States
Valerius Medical Group
🇺🇸Los Alamitos, California, United States
Inland Rheumatology; Clinical Trials, Inc.
🇺🇸Upland, California, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
New England Research Associates
🇺🇸Trumbull, Connecticut, United States
Arthritis & Rheumatism; Disease Specialities
🇺🇸Aventura, Florida, United States
Rheumatolgy Consultants of Deleware
🇺🇸Lewes, Delaware, United States
Javed Rheumatology Associates, Inc.
🇺🇸Newark, Delaware, United States
Robert Levin, Md; Research Dept
🇺🇸Dunedin, Florida, United States
Arthritis Rsrch of Florida, Inc.
🇺🇸Palm Harbor, Florida, United States
Jeffrey Alper M.D Research
🇺🇸Naples, Florida, United States
Arthritis Center Palm Harbor
🇺🇸Palm Harbor, Florida, United States
West Broward Rheumatology Associates, Inc.
🇺🇸Tamarac, Florida, United States
Pinellas Medical Research - Allegry & Rheumatology Associates, LLC
🇺🇸Saint Petersburg, Florida, United States
Sarasota Arthritis Res Center
🇺🇸Sarasota, Florida, United States
Advanced Clinical Research of Orlando, Inc.
🇺🇸Winter Garden, Florida, United States
North Georgia Rheumatology
🇺🇸Duluth, Georgia, United States
Arthritis Center of North Georgia
🇺🇸Gainesville, Georgia, United States
North Georgia Rheumatology Group, PC
🇺🇸Lawrenceville, Georgia, United States
Institute of Arthritis Research
🇺🇸Idaho Falls, Idaho, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Kansas City Internal Medicine
🇺🇸Overland Park, Kansas, United States
Klein & Associates, M.D., P.A.
🇺🇸Hagerstown, Maryland, United States
Arthritis & Diabetes Clinic, Inc
🇺🇸Monroe, Louisiana, United States
Mansfield Medical Center
🇺🇸Mansfield, Massachusetts, United States
Reliant Medical Group, Inc; Rheumatology
🇺🇸Worcester, Massachusetts, United States
Fiechtner Research Inc
🇺🇸Lansing, Michigan, United States
Arthritis and Osteoporosis; Treatment and Research Center
🇺🇸Flowood, Mississippi, United States
Jackson Arthritis Clinic
🇺🇸Flowood, Mississippi, United States
David S Rosenberg
🇺🇸Florissant, Missouri, United States
Arthritis Consultants
🇺🇸Saint Louis, Missouri, United States
Nashua Rheumatology - Foundation Medical Partners
🇺🇸Nashua, New Hampshire, United States
Arthritis Rheumatic & Back Disease Associates
🇺🇸Voorhees, New Jersey, United States
Cooper Cancer Institute
🇺🇸Voorhees, New Jersey, United States
Rheumatology Associates of Long Island
🇺🇸Smithtown, New York, United States
Arthritis Health Associates
🇺🇸Syracuse, New York, United States
Carolina Bone & Joint P.A.
🇺🇸Charlotte, North Carolina, United States
Asheville Arthritis & Osteoporosis Center, PA
🇺🇸Asheville, North Carolina, United States
Medication Management
🇺🇸Greensboro, North Carolina, United States
PMG Research of Hickory LLC
🇺🇸Hickory, North Carolina, United States
Shanahan Rheumatology & Immunology, PLLC
🇺🇸Raleigh, North Carolina, United States
STAT Research Inc
🇺🇸Dayton, Ohio, United States
Clinical Research Source, Inc.
🇺🇸Toledo, Ohio, United States
Arthritis Care Center Oklahoma
🇺🇸Ardmore, Oklahoma, United States
Oklahoma Center For Arthritis Therapy & Research
🇺🇸Tulsa, Oklahoma, United States
Healthcare Research Consultants
🇺🇸Tulsa, Oklahoma, United States
Columbia Arthritis Center (Partnership Practice)
🇺🇸Columbia, South Carolina, United States
Piedmont Arthritis Clinic
🇺🇸Greenville, South Carolina, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Diagnostic Group
🇺🇸Beaumont, Texas, United States
AOCBV
🇺🇸College Station, Texas, United States
Houston Inst. For Clinical Research
🇺🇸Houston, Texas, United States
Metroplex Clinical Research
🇺🇸Dallas, Texas, United States
Southwest Rheumatology
🇺🇸Mesquite, Texas, United States
Accurate Clinical Management
🇺🇸San Antonio, Texas, United States
Arthritis Clinic Of Central Texas
🇺🇸San Marcos, Texas, United States
Crossroads Clinical Research, LLC
🇺🇸Victoria, Texas, United States
South Puget Sound Clinical Research
🇺🇸Olympia, Washington, United States
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
Rheumatic Disease Center
🇺🇸Glendale, Wisconsin, United States
Arthritis Northwest, Spokane
🇺🇸Spokane, Washington, United States
Mountain State Clinical Research
🇺🇸Clarksburg, West Virginia, United States
Lakeshore Orthopedics
🇺🇸Manitowoc, Wisconsin, United States
Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
🇺🇸Onalaska, Wisconsin, United States
Rheumatology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Arthritis and Rheumatology Clinic
🇺🇸Orlando, Florida, United States
Clinical Research Consultants,LLC
🇺🇸Kansas City, Missouri, United States
Low Country Rheumatology, PA
🇺🇸Charleston, South Carolina, United States
Bluegrass Comm Research, Inc.
🇺🇸Lexington, Kentucky, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Austin Regional Clinic
🇺🇸Austin, Texas, United States
Lovelace Scientific Resources Inc.
🇺🇸Austin, Texas, United States