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

NCT02832297 | Unknown

• 1 other identifier: 088-CL-01
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 40

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Percentage of subjects with ACR20 response at Month 6

  Baseline to 6 months

• Change in HAQ-DI score at Month 6

  Baseline to 6 months

• Percentage of subjects with radiographic non-progression at 12 months

  Baseline to 12 months

• Total cost of RA-related treatment, in US dollars, at Month 6

  Baseline to 6 months

• Total cost of RA-related treatment, in US dollars, at Month 12

  Baseline to 12 months

Other Outcomes (16)

• Percentage of subjects with low disease activity (DAS28 <3.2) at Month 6

  Baseline to 6 months

• Percentage of subjects with low disease activity (DAS28 <3.2) at Month 12

  Baseline to 12 months

• Percentage of subjects with EULAR response at Month 6

  Baseline to 6 months

Study Arms (2)

Vectra DA (Arm A)

OTHER

Treatment intensification with non-biologic DMARDS guided by Vectra DA

Other: Vectra DA

Usual care (Arm B)

OTHER

Treatment intensification by usual care without using Vectra DA

Other: Usual Care

Interventions

Vectra DA OTHER

Vectra DA (Arm A)

Usual Care OTHER

Usual care (Arm B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Crescendo Bioscience: lead

Study Sites (40)

Rheumatology Associates of North Alabama PC

Huntsville, Alabama, 35801-4414, United States

RECRUITING

Dana Copeland Redyy Rheumatology

Chula Vista, California, 91910, United States

RECRUITING

Medvin Clinical Research

Covina, California, 91723, United States

RECRUITING

Western Connecticut Health Network

Danbury, Connecticut, 06810, United States

RECRUITING

Delaware Arthritis

Lewes, Delaware, 19958, United States

RECRUITING

Howard University

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

NOT YET RECRUITING

Robert W. Levin, MD

Clearwater, Florida, 33765, United States

RECRUITING

Arthritis Research Associates of Florida

Palm Harbor, Florida, 34684, United States

RECRUITING

Kenneth Stark, MD

Tavares, Florida, 32778, United States

RECRUITING

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

RECRUITING

Rheumatology Associates of Baltimore

Baltimore, Maryland, 21286, United States

WITHDRAWN

The Center for Rheumatology and Bone Research

Wheaton, Maryland, 20902, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

June DO, PC

Lansing, Michigan, 48910, United States

RECRUITING

Beals institute PC

Lansing, Michigan, 48917, United States

RECRUITING

Shores Rheumatology, P.C.

Saint Clair Shores, Michigan, 48081, United States

RECRUITING

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

RECRUITING

Timothy Kelly, MD

Las Vegas, Nevada, 89128, United States

WITHDRAWN

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

RECRUITING

Prospect Medical Offices Valley Medical Group

Midland Park, New Jersey, 07432, United States

RECRUITING

Overlook Medical Center Wound Healing Center

Summit, New Jersey, 07901, United States

RECRUITING

Rheumatology Associates of Long Island

Smithtown, New York, 11787, United States

RECRUITING

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

RECRUITING

Carolina Specialty Care

Statesville, North Carolina, 28625, United States

RECRUITING

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

RECRUITING

Paramount Medical Research, LLC

Middleburg Heights, Ohio, 44130, United States

RECRUITING

Southern Ohio Rheumatology

Wheelersburg, Ohio, 45694, United States

RECRUITING

Dr. Alan Kivitz

Duncansville, Pennsylvania, 16635-1018, United States

RECRUITING

Clinical Research Center of Reading, LLC

Wyomissing, Pennsylvania, 19610, United States

RECRUITING

Carolina Health Specialist

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

University of Tennesee Health Science

Memphis, Tennessee, 38104, United States

NOT YET RECRUITING

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

RECRUITING

Accurate Clinical Research

Nassau Bay, Texas, 77058, United States

RECRUITING

Arthritis Clinic of Central Texas

San Marcos, Texas, 78666, United States

RECRUITING

Arthritis Clinic of Northern VA, PC

Arlington, Virginia, 22205, United States

RECRUITING

Arthritis & Rheumatic Disease

Burke, Virginia, 22015, United States

RECRUITING

Western Washington Arthritis Clinic

Bothell, Washington, 98021, United States

RECRUITING

The Polyclinic

Seattle, Washington, 98104, United States

RECRUITING

Arthritis Northwest, P.L.L.C

Spokane, Washington, 99204, United States

RECRUITING

Gundersen Clinic, Ltd.

Onalaska, Wisconsin, 54650, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

David Chernoff, MD

CONTACT

650-351-3056; dchernoff@crescendobio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 14, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 30, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (40)