Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 8/1/2018 |
Start Date: | June 2016 |
End Date: | August 2022 |
Contact: | David Chernoff, MD |
Email: | dchernoff@crescendobio.com |
Phone: | 650-351-3056 |
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.
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.
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.
(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.
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.
We found this trial at
40
sites
1340 Wonder World Drive
San Marcos, Texas 78666
San Marcos, Texas 78666
Principal Investigator: Alissa Hassan, MD
Phone: 608-848-8900
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500 S State St
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Elena Schiopu, MD
Phone: 734-647-8173
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Arlington, Virginia 22205
Principal Investigator: Phillip Kempf, MD
Phone: 703-525-3069
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Berkeley Heights, New Jersey 07922
Principal Investigator: Lauren Kennish, MD
Phone: 908-277-8747
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1909 214th Street Southeast
Bothell, Washington 98021
Bothell, Washington 98021
Principal Investigator: Jeff Peterson, MD
Phone: 425-248-2635
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Bowling Green, Kentucky 42101
Principal Investigator: Asad Fraser, MD
Phone: 270-393-2786
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Burke, Virginia 22015
Principal Investigator: Neil Stahl, MD
Phone: 703-425-4435
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Chula Vista, California 91910
Principal Investigator: Dana Reddy, MD
Phone: 619-427-1721
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Clearwater, Florida 33765
Principal Investigator: Robert Levin, MD
Phone: 727-734-6631
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Covina, California 91723
Principal Investigator: Samy Metyas, MD
Phone: 626-869-5730
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24 Hospital Avenue
Danbury, Connecticut 06810
Danbury, Connecticut 06810
Principal Investigator: Michael Spiegel, MD
Phone: 203-794-5610
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1125 Old Route 220 North
Duncansville, Pennsylvania 16635
Duncansville, Pennsylvania 16635
Principal Investigator: Alan Kivitz, MD
Phone: 814-693-0300
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Huntsville, Alabama 35801
Principal Investigator: William J Shergy, MD
Phone: 256-704-7098
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Lansing, Michigan 48917
Principal Investigator: Patricia Cagnoli, MD
Phone: 517-886-5466
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Memphis, Tennessee 38104
Principal Investigator: Syed Hasan Raza, MD
Phone: 901-516-2212
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Mesquite, Texas 75150
Principal Investigator: Atul Singhal, MD
Phone: 972-288-2600
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Middleburg Heights, Ohio 44130
Principal Investigator: Isam Diab, MD
Phone: 440-826-0742
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Midland Park, New Jersey 07432
Principal Investigator: Evan Leibowitz, MD
Phone: 201-444-4530
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Myrtle Beach, South Carolina 29572
Principal Investigator: Douglas Conaway, MD
Phone: 843-497-5929
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Nassau Bay, Texas 77058
Principal Investigator: Prashanth Sunkureddi, MD
Phone: 281-240-1045
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Onalaska, Wisconsin 54650
Principal Investigator: Carol Danning, MD
Phone: 608-775-7008
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Palm Harbor, Florida 34684
Principal Investigator: Anthony Sebba, MD
Phone: 727-210-2555
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
Saint Clair Shores, Michigan 48081
Principal Investigator: Amar Majjihoo, MD
Phone: 586-777-7577
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Seattle, Washington 98122
Principal Investigator: Anthony Krajcer, MD
Phone: 206-860-5433
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Smithtown, New York 11787
Principal Investigator: Peter Rumore, MD
Phone: 631-360-7778
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Spokane, Washington 99204
Principal Investigator: Howard Kenney, MD
Phone: 509-462-2808
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Statesville, North Carolina 28625
Principal Investigator: Bob Wodecki, MD
Phone: 704-872-8711
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Summit, New Jersey 07901
Principal Investigator: Elliott Rosenstein, MD
Phone: 908-522-6156
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Tavares, Florida 32778
Principal Investigator: Kenneth Stark, MD
Phone: 352-343-7735
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Tupelo, Mississippi 38801
Principal Investigator: Charles King, MD
Phone: 662-377-5131
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Washington, District of Columbia 20060
Principal Investigator: Mercedes Quinones, MD
Phone: 202-865-3326
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Wheaton, Maryland 20902
Principal Investigator: Paul DeMarco, MD
Phone: 301-942-7833
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Wheelersburg, Ohio 45694
Principal Investigator: Rajesh Kataria, MD
Phone: 740-355-8562
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1907 Tradd Ct
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
(910) 799-5500
Principal Investigator: Ronald George, MD
Phone: 910-815-6108
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Wyomissing, Pennsylvania 19610
Principal Investigator: Robert Griffin, MD
Phone: 610-375-2466
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