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Arthritis, RheumatoidNCT02832297

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

A study testing Vectra DA in people with Arthritis, Rheumatoid, run by Crescendo Bioscience at 40 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
Vectra DA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
40 sitesUnited States
Study dates
Jun 2016to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 26Show fewer
  • 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.

Trial locations and contacts

40 sites in 1 country.

David Chernoff, MD contact

650-351-3056

dchernoff@crescendobio.com

40 sites in 1 country

United States40 sites, 38 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    734-647-8173

    Elena Schiopu, MD

    Recruiting

  • Arthritis Clinic of Northern VA, PC

    Arlington, Virginia, 22205

    703-525-3069

    Phillip Kempf, MD

    Recruiting

  • Rheumatology Associates of Baltimore

    Baltimore, Maryland, 21286

    Withdrawn

  • Summit Medical Group

    Berkeley Heights, New Jersey, 07922

    908-277-8747

    Lauren Kennish, MD

    Recruiting

  • Western Washington Arthritis Clinic

    Bothell, Washington, 98021

    425-248-2635

    Jeff Peterson, MD

    Recruiting

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

    270-393-2786

    Asad Fraser, MD

    Recruiting

  • Arthritis & Rheumatic Disease

    Burke, Virginia, 22015

    703-425-4435

    Neil Stahl, MD

    Recruiting

  • Dana Copeland Redyy Rheumatology

    Chula Vista, California, 91910

    619-427-1721

    Dana Reddy, MD

    Recruiting

  • Robert W. Levin, MD

    Clearwater, Florida, 33765

    727-734-6631

    Robert Levin, MD

    Recruiting

  • Medvin Clinical Research

    Covina, California, 91723

    626-869-5730

    Samy Metyas, MD

    Recruiting

  • Western Connecticut Health Network

    Danbury, Connecticut, 06810

    203-794-5610

    Michael Spiegel, MD

    Recruiting

  • Dr. Alan Kivitz

    Duncansville, Pennsylvania, 16635-1018

    814-693-0300, altoonaresearch@gmail.com

    Alan Kivitz, MD

    Recruiting

  • Rheumatology Associates of North Alabama PC

    Huntsville, Alabama, 35801-4414

    256-704-7098

    William J Shergy, MD

    Recruiting

  • June DO, PC

    Lansing, Michigan, 48910

    517-272-9727

    Joshua June, DO

    Recruiting

  • Beals institute PC

    Lansing, Michigan, 48917

    517-886-5466

    Patricia Cagnoli, MD

    Recruiting

  • Timothy Kelly, MD

    Las Vegas, Nevada, 89128

    Withdrawn

  • Delaware Arthritis

    Lewes, Delaware, 19958

    302-644-2633

    Jose Pando, MD

    Recruiting

  • University of Tennesee Health Science

    Memphis, Tennessee, 38104

    901-516-2212

    Syed Hasan Raza, MD

    Not yet recruiting

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150

    972-288-2600

    Atul Singhal, MD

    Recruiting

  • Paramount Medical Research, LLC

    Middleburg Heights, Ohio, 44130

    440-826-0742

    Isam Diab, MD

    Recruiting

  • Prospect Medical Offices Valley Medical Group

    Midland Park, New Jersey, 07432

    201-444-4530

    Evan Leibowitz, MD

    Recruiting

  • Carolina Health Specialist

    Myrtle Beach, South Carolina, 29572

    843-497-5929

    Douglas Conaway, MD

    Recruiting

  • Accurate Clinical Research

    Nassau Bay, Texas, 77058

    281-240-1045

    Prashanth Sunkureddi, MD

    Recruiting

  • Gundersen Clinic, Ltd.

    Onalaska, Wisconsin, 54650

    608-775-7008

    Carol Danning, MD

    Recruiting

  • Arthritis Research Associates of Florida

    Palm Harbor, Florida, 34684

    727-210-2555

    Anthony Sebba, MD

    Recruiting

  • Shores Rheumatology, P.C.

    Saint Clair Shores, Michigan, 48081

    586-777-7577

    Amar Majjihoo, MD

    Recruiting

  • PMG Research of Salisbury

    Salisbury, North Carolina, 28144

    Rakesh Patel, MD

    Recruiting

  • Arthritis Clinic of Central Texas

    San Marcos, Texas, 78666

    608-848-8900

    Alissa Hassan, MD

    Recruiting

  • The Polyclinic

    Seattle, Washington, 98104

    206-860-5433

    Anthony Krajcer, MD

    Recruiting

  • Rheumatology Associates of Long Island

    Smithtown, New York, 11787

    631-360-7778

    Peter Rumore, MD

    Recruiting

  • Arthritis Northwest, P.L.L.C

    Spokane, Washington, 99204

    509-462-2808

    Howard Kenney, MD

    Recruiting

  • Carolina Specialty Care

    Statesville, North Carolina, 28625

    704-872-8711

    Bob Wodecki, MD

    Recruiting

  • Overlook Medical Center Wound Healing Center

    Summit, New Jersey, 07901

    908-522-6156

    Elliott Rosenstein, MD

    Recruiting

  • Kenneth Stark, MD

    Tavares, Florida, 32778

    352-343-7735

    Kenneth Stark, MD

    Recruiting

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

    662-377-5131

    Charles King, MD

    Recruiting

  • Howard University

    Washington D.C., District of Columbia, 20060

    202-865-3326

    Mercedes Quinones, MD

    Not yet recruiting

  • The Center for Rheumatology and Bone Research

    Wheaton, Maryland, 20902

    301-942-7833

    Paul DeMarco, MD

    Recruiting

  • Southern Ohio Rheumatology

    Wheelersburg, Ohio, 45694

    740-355-8562

    Rajesh Kataria, MD

    Recruiting

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

    910-815-6108

    Ronald George, MD

    Recruiting

  • Clinical Research Center of Reading, LLC

    Wyomissing, Pennsylvania, 19610

    610-375-2466

    Robert Griffin, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Vectra DA, Usual Care
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vectra DAOther

  • Usual CareOther

Study groups in NCT02832297
Study groupRoleWhat they receive
Vectra DA (Arm A)OtherTreatment intensification with non-biologic DMARDS guided by Vectra DA
Receives: Other: Vectra DA
Usual care (Arm B)OtherTreatment intensification by usual care without using Vectra DA
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in DAS28 at Month 6

    Measured: Baseline to 6 months

  2. Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6

    Measured: Baseline to 6 months

Secondary outcomes (5)

  1. Percentage of subjects with ACR20 response at Month 6

    Measured: Baseline to 6 months

  2. Change in HAQ-DI score at Month 6

    Measured: Baseline to 6 months

  3. Percentage of subjects with radiographic non-progression at 12 months

    Radiographic non-progression will be defined as change in modified total Sharp score (ΔmTSS) ≤0.5 units from baseline to Month 12

    Measured: Baseline to 12 months

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

    Measured: Baseline to 6 months

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

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionAug 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832297
Sponsor's protocol ID
088-CL-01
Status last verified
Jul 2017
First submitted
7 Jul 2016
Last updated
30 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Vectra DA in people with Arthritis, Rheumatoid, run by Crescendo Bioscience at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact David Chernoff, MD (650-351-3056, dchernoff@crescendobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in DAS28 at Month 6 (time frame: Baseline to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02832297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.

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