Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care

Last updated: July 27, 2018
Sponsor: Crescendo Bioscience
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT02832297
088-CL-01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects will be eligible to participate in the study if they meet all the followingcriteria:

  1. Willing and able to sign an ICF

  2. Age 18 to 80 years at enrollment

  3. Meets the 2010 ACR/EULAR criteria and/or 1987 criteria for RA, as determined by aboard-certified rheumatologist ≥3 months prior to enrollment

  4. 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. Ahistory of therapy with split dose oral MTX or parenteral MTX is acceptable only ifthe weekly MTX dose was always ≤20 mg/week during the 3 months prior to enrollment.

  5. CDAI >10 as assessed by the Investigator at screening

  6. At least 3 swollen joints (SJC ≥3) and 3 tender joints (TJC ≥3) out of 28 joints asassessed by the Investigator at screening

  7. Must be eligible for treatment intensification with non-biologic and biologic DMARDs

  8. Documented evidence of seropositivity (RF and/or anti-CCP antibodies). Seronegativesubjects are allowed if erosive disease attributable to RA is documented on X-rays.

Exclusion

Exclusion Criteria: Subjects will be ineligible to participate in the study if they meet any of the followingcriteria:

  1. Use of a non-biologic DMARD other than MTX within 3 months prior to enrollment

  2. MTX administered SQ or as an oral split dose at >20 mg/week any time during the 3months prior to enrollment

  3. Two or more DMARDs used in combination (i.e., concomitantly), including but notlimited to: MTX, HCQ, SSZ, LEF, cyclosporine, azathioprine, gold or penicillamine anytime prior to enrollment

  4. Biologic DMARD or JAKi use any time prior to enrollment

  5. Any contraindication to use of MTX, HCQ, LEF or biologic DMARDs

  6. Opiate use during the 2 weeks prior to enrollment

  7. Oral corticosteroids during the month prior to enrollment at a dosage >10 mg/dayprednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (orequivalent)

  8. MTX intolerance prior to enrollment that limits its use

  9. Inflammatory joint disease (other than RA) or any other systemic autoimmune disorder. (Osteoarthritis is not a basis for exclusion.)

  10. Primary or secondary immunodeficiency

  11. Active infection (excluding fungal infection of nail beds); or acute or chronicinfection requiring hospitalization or treatment with parenteral systemic antibioticswithin one month of enrollment or treatment with oral antibiotics within 2 weeks ofenrollment

  12. IA, intravenous or IM corticosteroids during the month prior to enrollment

  13. Initiation or non-stable dosing of NSAIDs within 2 weeks prior to enrollment

  14. Vectra DA testing within 3 months prior to enrollment

  15. Live vaccine within 90 days of enrollment

  16. Active substance abuse or psychiatric illness likely to interfere with protocolconduct

  17. History of severe allergic or anaphylactic reaction to any monoclonal antibody therapy

  18. Known infection with HIV (HIV testing will not be a requirement for trial entry); apast or current history of hepatitis B virus or hepatitis C virus infection

  19. History of malignancy within the past five years or any evidence of persistentmalignancy, 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

  20. Pregnancy or inadequate contraception in women of childbearing potential

  21. Breast feeding or lactating

  22. Medical, psychiatric, cognitive or other conditions that, in the opinion of theInvestigator, may compromise the ability of the subject to understand the studyinformation, to give informed consent, to comply with the trial protocol, or tocomplete the study

  23. Presently enrolled in another clinical trial

  24. Vectra DA score at screening that is outside the applicable range as required forsubject enrollment Note: Screening for TB is not required for subjects participating in the study. If anInvestigator is considering a subject for treatment with a biologic DMARD in the study,guidelines for TB screening need to be followed.

Study Design

Total Participants: 318
Study Start date:
June 01, 2016
Estimated Completion Date:
August 31, 2022

Study 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.

Connect with a study center

  • Rheumatology Associates of North Alabama PC

    Huntsville, Alabama 35801-4414
    United States

    Active - Recruiting

  • Dana Copeland Redyy Rheumatology

    Chula Vista, California 91910
    United States

    Active - Recruiting

  • Medvin Clinical Research

    Covina, California 91723
    United States

    Active - Recruiting

  • Western Connecticut Health Network

    Danbury, Connecticut 06810
    United States

    Active - Recruiting

  • Delaware Arthritis

    Lewes, Delaware 19958
    United States

    Active - Recruiting

  • Howard University

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • Howard University

    Washington, D.C., District of Columbia 20060
    United States

    Site Not Available

  • Robert W. Levin, MD

    Clearwater, Florida 33765
    United States

    Active - Recruiting

  • Arthritis Research Associates of Florida

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Kenneth Stark, MD

    Tavares, Florida 32778
    United States

    Active - Recruiting

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Active - Recruiting

  • Rheumatology Associates of Baltimore

    Baltimore, Maryland 21286
    United States

    Site Not Available

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland 20902
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Beals institute PC

    Lansing, Michigan 48917
    United States

    Active - Recruiting

  • June DO, PC

    Lansing, Michigan 48910
    United States

    Active - Recruiting

  • Shores Rheumatology, P.C.

    Saint Clair Shores, Michigan 48081
    United States

    Active - Recruiting

  • Shores Rheumatology, P.C.

    St. Clair Shores, Michigan 48081
    United States

    Site Not Available

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • Timothy Kelly, MD

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Summit Medical Group

    Berkeley Heights, New Jersey 07922
    United States

    Active - Recruiting

  • Prospect Medical Offices Valley Medical Group

    Midland Park, New Jersey 07432
    United States

    Active - Recruiting

  • Overlook Medical Center Wound Healing Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Overlook Medical Center Wound Healing Center

    Summitt, New Jersey 07901
    United States

    Site Not Available

  • Rheumatology Associates of Long Island

    Smithtown, New York 11787
    United States

    Active - Recruiting

  • PMG Research of Salisbury

    Salisbury, North Carolina 28144
    United States

    Active - Recruiting

  • Carolina Specialty Care

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • PMG Research of Wilmington

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • Paramount Medical Research, LLC

    Middleburg Heights, Ohio 44130
    United States

    Active - Recruiting

  • Southern Ohio Rheumatology

    Wheelersburg, Ohio 45694
    United States

    Active - Recruiting

  • Dr. Alan Kivitz

    Duncansville, Pennsylvania 16635-1018
    United States

    Active - Recruiting

  • Clinical Research Center of Reading, LLC

    Wyomissing, Pennsylvania 19610
    United States

    Active - Recruiting

  • Carolina Health Specialist

    Myrtle Beach, South Carolina 29572
    United States

    Active - Recruiting

  • University of Tennesee Health Science

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • Southwest Rheumatology Research LLC

    Mesquite, Texas 75150
    United States

    Active - Recruiting

  • Accurate Clinical Research

    Nassau Bay, Texas 77058
    United States

    Active - Recruiting

  • Arthritis Clinic of Central Texas

    San Marcos, Texas 78666
    United States

    Active - Recruiting

  • Arthritis Clinic of Northern VA, PC

    Arlington, Virginia 22205
    United States

    Active - Recruiting

  • Arthritis & Rheumatic Disease

    Burke, Virginia 22015
    United States

    Active - Recruiting

  • Western Washington Arthritis Clinic

    Bothell, Washington 98021
    United States

    Active - Recruiting

  • The Polyclinic

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Arthritis Northwest, P.L.L.C

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Gundersen Clinic, Ltd.

    Onalaska, Wisconsin 54650
    United States

    Active - Recruiting

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