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

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.

Study Overview

• Status: Unknown
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Other: Usual Care; Other: Vectra DA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 318
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801-4414
      • Recruiting
      • Rheumatology Associates of North Alabama PC
      • Contact: Phone Number: 256-704-7098
      • Principal Investigator: William J Shergy, MD
  • California
    • Chula Vista, California, United States, 91910
      • Recruiting
      • Dana Copeland Redyy Rheumatology
      • Principal Investigator: Dana Reddy, MD
      • Contact: Phone Number: 619-427-1721
    • Covina, California, United States, 91723
      • Recruiting
      • Medvin Clinical Research
      • Contact: Phone Number: 626-869-5730
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Recruiting
      • Western Connecticut Health Network
      • Contact: Phone Number: 203-794-5610
      • Principal Investigator: Michael Spiegel, MD
  • Delaware
    • Lewes, Delaware, United States, 19958
      • Recruiting
      • Delaware Arthritis
      • Contact: Phone Number: 302-644-2633
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Not yet recruiting
      • Howard University
      • Contact: Phone Number: 202-865-3326
      • Principal Investigator: Mercedes Quinones, MD
  • Florida
    • Clearwater, Florida, United States, 33765
      • Recruiting
      • Robert W. Levin, MD
      • Principal Investigator: Robert Levin, MD
      • Contact: Phone Number: 727-734-6631
    • Palm Harbor, Florida, United States, 34684
      • Recruiting
      • Arthritis Research Associates of Florida
      • Contact: Phone Number: 727-210-2555
      • Principal Investigator: Anthony Sebba, MD
    • Tavares, Florida, United States, 32778
      • Recruiting
      • Kenneth Stark, MD
      • Contact: Phone Number: 352-343-7735
      • Principal Investigator: Kenneth Stark, MD
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Recruiting
      • Graves Gilbert Clinic
      • Contact: Phone Number: 270-393-2786
      • Principal Investigator: Asad Fraser, MD
  • Maryland
    • Baltimore, Maryland, United States, 21286
      • Withdrawn
      • Rheumatology Associates of Baltimore
    • Wheaton, Maryland, United States, 20902
      • Recruiting
      • The Center for Rheumatology and Bone Research
      • Contact: Phone Number: 301-942-7833
      • Principal Investigator: Paul DeMarco, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Phone Number: 734-647-8173
      • Principal Investigator: Elena Schiopu, MD
    • Lansing, Michigan, United States, 48910
      • Recruiting
      • June DO, PC
      • Contact: Phone Number: 517-272-9727
    • Lansing, Michigan, United States, 48917
      • Recruiting
      • Beals Institute PC
      • Contact: Phone Number: 517-886-5466
      • Principal Investigator: Patricia Cagnoli, MD
    • Saint Clair Shores, Michigan, United States, 48081
      • Recruiting
      • Shores Rheumatology, P.C.
      • Contact: Phone Number: 586-777-7577
      • Principal Investigator: Amar Majjihoo, MD
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • North Mississippi Medical Center
      • Principal Investigator: Charles King, MD
      • Contact: Phone Number: 662-377-5131
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Withdrawn
      • Timothy Kelly, MD
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Recruiting
      • Summit Medical Group
      • Contact: Phone Number: 908-277-8747
      • Principal Investigator: Lauren Kennish, MD
    • Midland Park, New Jersey, United States, 07432
      • Recruiting
      • Prospect Medical Offices Valley Medical Group
      • Contact: Phone Number: 201-444-4530
      • Principal Investigator: Evan Leibowitz, MD
    • Summit, New Jersey, United States, 07901
      • Recruiting
      • Overlook Medical Center Wound Healing Center
      • Contact: Phone Number: 908-522-6156
      • Principal Investigator: Elliott Rosenstein, MD
  • New York
    • Smithtown, New York, United States, 11787
      • Recruiting
      • Rheumatology Associates of Long Island
      • Contact: Phone Number: 631-360-7778
      • Principal Investigator: Peter Rumore, MD
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Recruiting
      • PMG Research of Salisbury
    • Statesville, North Carolina, United States, 28625
      • Recruiting
      • Carolina Specialty Care
      • Contact: Phone Number: 704-872-8711
      • Principal Investigator: Bob Wodecki, MD
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • PMG Research of Wilmington
      • Contact: Phone Number: 910-815-6108
      • Principal Investigator: Ronald George, MD
  • Ohio
    • Middleburg Heights, Ohio, United States, 44130
      • Recruiting
      • Paramount Medical Research, LLC
      • Principal Investigator: Isam Diab, MD
    • Wheelersburg, Ohio, United States, 45694
      • Recruiting
      • Southern Ohio Rheumatology
      • Contact: Phone Number: 740-355-8562
      • Principal Investigator: Rajesh Kataria, MD
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635-1018
      • Recruiting
      • Dr. Alan Kivitz
      • Principal Investigator: Alan Kivitz, MD
      • Contact: Phone Number: 814-693-0300; Email: altoonaresearch@gmail.com
    • Wyomissing, Pennsylvania, United States, 19610
      • Recruiting
      • Clinical Research Center of Reading, LLC
      • Contact: Phone Number: 610-375-2466
      • Principal Investigator: Robert Griffin, MD
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Recruiting
      • Carolina Health Specialist
      • Contact: Phone Number: 843-497-5929
      • Principal Investigator: Douglas Conaway, MD
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Not yet recruiting
      • University of Tennesee Health Science
      • Contact: Phone Number: 901-516-2212
      • Principal Investigator: Syed Hasan Raza, MD
  • Texas
    • Mesquite, Texas, United States, 75150
      • Recruiting
      • Southwest Rheumatology Research LLC
      • Contact: Phone Number: 972-288-2600
    • Nassau Bay, Texas, United States, 77058
      • Recruiting
      • Accurate Clinical Research
      • Principal Investigator: Prashanth Sunkureddi, MD
    • San Marcos, Texas, United States, 78666
      • Recruiting
      • Arthritis Clinic of Central Texas
      • Principal Investigator: Alissa Hassan, MD
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Recruiting
      • Arthritis Clinic of Northern VA, PC
      • Contact: Phone Number: 703-525-3069
      • Principal Investigator: Phillip Kempf, MD
    • Burke, Virginia, United States, 22015
      • Recruiting
      • Arthritis & Rheumatic Disease
      • Contact: Phone Number: 703-425-4435
      • Principal Investigator: Neil Stahl, MD
  • Washington
    • Bothell, Washington, United States, 98021
      • Recruiting
      • Western Washington Arthritis Clinic
    • Seattle, Washington, United States, 98104
      • Recruiting
      • The Polyclinic
      • Contact: Phone Number: 206-860-5433
      • Principal Investigator: Anthony Krajcer, MD
    • Spokane, Washington, United States, 99204
      • Recruiting
      • Arthritis Northwest, P.L.L.C
      • Principal Investigator: Howard Kenney, MD
      • Contact: Phone Number: 509-462-2808
  • Wisconsin
    • Onalaska, Wisconsin, United States, 54650
      • Recruiting
      • Gundersen Clinic, Ltd.
      • Contact: Phone Number: 608-775-7008
      • Principal Investigator: Carol Danning, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects will be eligible to participate in the study if they meet all the following criteria:

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 a board-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. 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.
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 as assessed 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). Seronegative subjects are allowed if erosive disease attributable to RA is documented on X-rays.

Exclusion Criteria:

Subjects will be ineligible to participate in the study if they meet any of the following criteria:

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 3 months prior to enrollment
3. 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
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/day prednisone (or equivalent) or at a non-stable dose ≤10 mg/day prednisone (or equivalent)
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 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
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 protocol conduct
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); a past 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 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
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 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
23. Presently enrolled in another clinical trial
24. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vectra DA (Arm A); Treatment intensification with non-biologic DMARDS guided by Vectra DA	Other: Vectra DA
Other: Usual care (Arm B); Treatment intensification by usual care without using Vectra DA	Other: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Outcome Measure	Time Frame
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
Percentage of subjects with EULAR response at Month 12	Baseline to 12 months
Percentage of subjects with ACR50 response at Month 6	Baseline to 6 months
Percentage of subjects with ACR50 response at Month 12	Baseline to 12 months
Change in mTSS at Month 12	Baseline to 12 months
Change in HAQ-DI score at Month 12	Baseline to 12 months
Percentage of subjects with SAE	Baseline to 12 months
Change in work productivity as measured by the WPS-RA at Month 6	Baseline to 6 months
Change in work productivity as measured by the WPS-RA at Month 12	Baseline to 12 months
Change in health related QOL as measured by SF-36 at Month 6	Baseline to 6 months
Change in health related QOL as measured by SF-36 at Month 12	Baseline to 12 months
Change in health related QOL as measured by EQ-5D-5L at Month 6	Baseline to 6 months
Change in health related QOL as measured by EQ-5D-5L at Month 12	Baseline to 12 months
Percentage of subjects Incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained at Month 12	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Crescendo Bioscience

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 088-CL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES