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

Status unconfirmed · Not applicable

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID: NCT02832297
Run by: Crescendo Bioscience
People needed: 318
Starts: 2016-06-01
Expected to finish: 2022-08-01
Last updated by the study team: 2018-07-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Gundersen Clinic, Ltd. — Onalaska, Wisconsin, United States (enrolling)
Dana Copeland Redyy Rheumatology — Chula Vista, California, United States (enrolling)
Medvin Clinical Research — Covina, California, United States (enrolling)
Western Connecticut Health Network — Danbury, Connecticut, United States (enrolling)
Delaware Arthritis — Lewes, Delaware, United States (enrolling)
Western Washington Arthritis Clinic — Bothell, Washington, United States (enrolling)
The Polyclinic — Seattle, Washington, United States (enrolling)
Arthritis Northwest, P.L.L.C — Spokane, Washington, United States (enrolling)
Rheumatology Associates of North Alabama PC — Huntsville, Alabama, United States (enrolling)
Robert W. Levin, MD — Clearwater, Florida, United States (enrolling)
Arthritis Research Associates of Florida — Palm Harbor, Florida, United States (enrolling)
Kenneth Stark, MD — Tavares, Florida, United States (enrolling)
Graves Gilbert Clinic — Bowling Green, Kentucky, United States (enrolling)
The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States (enrolling)
University of Michigan — Ann Arbor, Michigan, United States (enrolling)
June DO, PC — Lansing, Michigan, United States (enrolling)
Beals institute PC — Lansing, Michigan, United States (enrolling)
Shores Rheumatology, P.C. — Saint Clair Shores, Michigan, United States (enrolling)
North Mississippi Medical Center — Tupelo, Mississippi, United States (enrolling)
Summit Medical Group — Berkeley Heights, New Jersey, United States (enrolling)
Prospect Medical Offices Valley Medical Group — Midland Park, New Jersey, United States (enrolling)
Overlook Medical Center Wound Healing Center — Summit, New Jersey, United States (enrolling)
Rheumatology Associates of Long Island — Smithtown, New York, United States (enrolling)
PMG Research of Salisbury — Salisbury, North Carolina, United States (enrolling)
Carolina Specialty Care — Statesville, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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