Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Other: Vectra DAOther: Usual Care
- Registration Number
- NCT02832297
- Lead Sponsor
- Crescendo Bioscience
- Brief Summary
In this 12-month multi-center prospective, site-randomized, two-arm trial, approximately 318 biologic-naïve subjects with RA who are candidates for treatment intensification due to inadequate response to MTX monotherapy will be enrolled at up to 60 study sites.
- Detailed Description
To determine whether a strategy of Vectra DA guided care (Arm A), compared with usual care (Arm B), achieves non-inferior clinical outcomes while reducing the cost of treatment in patients with active RA and an inadequate response to MTX monotherapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 318
Subjects will be eligible to participate in the study if they meet all the following criteria:
- Willing and able to sign an ICF
- Age 18 to 80 years at enrollment
- Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by a board-certified rheumatologist ≥3 months prior to enrollment
- Received uninterrupted treatment with weekly MTX begun ≥3 months prior to enrollment, at a stable dose of ≥15 mg per week for at least 4 weeks prior to enrollment. A history of therapy with split dose oral MTX or parenteral MTX is acceptable only if the weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.
- CDAI >10 as assessed by the Investigator at screening
- At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints as assessed by the Investigator at screening
- Must be eligible for treatment intensification with non-biologic and biologic DMARDs
- Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegative subjects are allowed if erosive disease attributable to RA is documented on X-rays.
Subjects will be ineligible to participate in the study if they meet any of the following criteria:
- Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment
- MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3 months prior to enrollment
- Two or more DMARDs used in combination (i.e., concomitantly), including but not limited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine any time prior to enrollment
- Biologic DMARD or JAKi use any time prior to enrollment
- Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs
- Opiate use during the 2 weeks prior to enrollment
- Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
- MTX intolerance prior to enrollment that limits its use
- Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)
- Primary or secondary immunodeficiency
- Active infection (excluding fungal infection of nail beds); or acute or chronic infection requiring hospitalization or treatment with parenteral systemic antibiotics within one month of enrollment or treatment with oral antibiotics within 2 weeks of enrollment
- IA, intravenous or IM corticosteroids during the month prior to enrollment
- Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment
- Vectra DA testing within 3 months prior to enrollment
- Live vaccine within 90 days of enrollment
- Active substance abuse or psychiatric illness likely to interfere with protocol conduct
- History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy
- Known infection with HIV (HIV testing will not be a requirement for trial entry); a past or current history of hepatitis B virus or hepatitis C virus infection
- History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure
- Pregnancy or inadequate contraception in women of childbearing potential
- Breast feeding or lactating
- Medical, psychiatric, cognitive or other conditions that, in the opinion of the Investigator, may compromise the ability of the subject to understand the study information, to give informed consent, to comply with the trial protocol, or to complete the study
- Presently enrolled in another clinical trial
- Vectra DA score at screening that is outside the applicable range as required for subject enrollment
Note: Screening for TB is not required for subjects participating in the study. If an Investigator is considering a subject for treatment with a biologic DMARD in the study, guidelines for TB screening need to be followed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vectra DA (Arm A) Vectra DA Treatment intensification with non-biologic DMARDS guided by Vectra DA Usual care (Arm B) Usual Care Treatment intensification by usual care without using Vectra DA
- Primary Outcome Measures
Name Time Method Change in DAS28 at Month 6 Baseline to 6 months Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6 Baseline to 6 months
- Secondary Outcome Measures
Name Time Method Percentage of subjects with ACR20 response at Month 6 Baseline to 6 months Total cost of RA-related treatment, in US dollars, at Month 6 Baseline to 6 months Change in HAQ-DI score at Month 6 Baseline to 6 months Total cost of RA-related treatment, in US dollars, at Month 12 Baseline to 12 months Percentage of subjects with radiographic non-progression at 12 months Baseline to 12 months Radiographic non-progression will be defined as change in modified total Sharp score (ΔmTSS) ≤0.5 units from baseline to Month 12
Trial Locations
- Locations (40)
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Accurate Clinical Research
🇺🇸Nassau Bay, Texas, United States
Clinical Research Center of Reading, LLC
🇺🇸Wyomissing, Pennsylvania, United States
Carolina Health Specialist
🇺🇸Myrtle Beach, South Carolina, United States
Timothy Kelly, MD
🇺🇸Las Vegas, Nevada, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
Arthritis Clinic of Northern VA, PC
🇺🇸Arlington, Virginia, United States
Rheumatology Associates of North Alabama PC
🇺🇸Huntsville, Alabama, United States
Dana Copeland Redyy Rheumatology
🇺🇸Chula Vista, California, United States
Medvin Clinical Research
🇺🇸Covina, California, United States
Western Connecticut Health Network
🇺🇸Danbury, Connecticut, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Robert W. Levin, MD
🇺🇸Clearwater, Florida, United States
Arthritis Research Associates of Florida
🇺🇸Palm Harbor, Florida, United States
Kenneth Stark, MD
🇺🇸Tavares, Florida, United States
Graves Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Rheumatology Associates of Baltimore
🇺🇸Baltimore, Maryland, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Beals institute PC
🇺🇸Lansing, Michigan, United States
Prospect Medical Offices Valley Medical Group
🇺🇸Midland Park, New Jersey, United States
Overlook Medical Center Wound Healing Center
🇺🇸Summit, New Jersey, United States
Carolina Specialty Care
🇺🇸Statesville, North Carolina, United States
Rheumatology Associates of Long Island
🇺🇸Smithtown, New York, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Paramount Medical Research, LLC
🇺🇸Middleburg Heights, Ohio, United States
Southern Ohio Rheumatology
🇺🇸Wheelersburg, Ohio, United States
Dr. Alan Kivitz
🇺🇸Duncansville, Pennsylvania, United States
University of Tennesee Health Science
🇺🇸Memphis, Tennessee, United States
Arthritis Clinic of Central Texas
🇺🇸San Marcos, Texas, United States
Arthritis & Rheumatic Disease
🇺🇸Burke, Virginia, United States
Western Washington Arthritis Clinic
🇺🇸Bothell, Washington, United States
The Polyclinic
🇺🇸Seattle, Washington, United States
Arthritis Northwest, P.L.L.C
🇺🇸Spokane, Washington, United States
Gundersen Clinic, Ltd.
🇺🇸Onalaska, Wisconsin, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
June DO, PC
🇺🇸Lansing, Michigan, United States
Delaware Arthritis
🇺🇸Lewes, Delaware, United States
Shores Rheumatology, P.C.
🇺🇸Saint Clair Shores, Michigan, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Southwest Rheumatology Research LLC
🇺🇸Mesquite, Texas, United States