Clinical trial NCT02832297: Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
Official title: Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthritis, Rheumatoid
Lead sponsor: Crescendo Bioscience
Sponsor class: INDUSTRY
First posted: 2016-07-14
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in DAS28 at Month 6
timeFrame: Baseline to 6 months
measure: Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Percentage of subjects with ACR20 response at Month 6
timeFrame: Baseline to 6 months
measure: Change in HAQ-DI score at Month 6
timeFrame: Baseline to 6 months
measure: Percentage of subjects with radiographic non-progression at 12 months
timeFrame: Baseline to 12 months
measure: Total cost of RA-related treatment, in US dollars, at Month 6
timeFrame: Baseline to 6 months
measure: Total cost of RA-related treatment, in US dollars, at Month 12
timeFrame: Baseline to 12 months
Other outcomes:
measure: Percentage of subjects with low disease activity (DAS28 <3.2) at Month 6
timeFrame: Baseline to 6 months
measure: Percentage of subjects with low disease activity (DAS28 <3.2) at Month 12
timeFrame: Baseline to 12 months
measure: Percentage of subjects with EULAR response at Month 6
timeFrame: Baseline to 6 months
measure: Percentage of subjects with EULAR response at Month 12
timeFrame: Baseline to 12 months
measure: Percentage of subjects with ACR50 response at Month 6
timeFrame: Baseline to 6 months
measure: Percentage of subjects with ACR50 response at Month 12
timeFrame: Baseline to 12 months
measure: Change in mTSS at Month 12
timeFrame: Baseline to 12 months
measure: Change in HAQ-DI score at Month 12
timeFrame: Baseline to 12 months
measure: Percentage of subjects with SAE
timeFrame: Baseline to 12 months
measure: Change in work productivity as measured by the WPS-RA at Month 6
timeFrame: Baseline to 6 months
measure: Change in work productivity as measured by the WPS-RA at Month 12
timeFrame: Baseline to 12 months
measure: Change in health related QOL as measured by SF-36 at Month 6
timeFrame: Baseline to 6 months
measure: Change in health related QOL as measured by SF-36 at Month 12
timeFrame: Baseline to 12 months
measure: Change in health related QOL as measured by EQ-5D-5L at Month 6
timeFrame: Baseline to 6 months
measure: Change in health related QOL as measured by EQ-5D-5L at Month 12
timeFrame: Baseline to 12 months
measure: Percentage of subjects Incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained at Month 12
timeFrame: Baseline to 12 months
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama PC
state: Alabama
city: Chula Vista
country: United States
facility: Dana Copeland Redyy Rheumatology
state: California
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Danbury
country: United States
facility: Western Connecticut Health Network
state: Connecticut
city: Lewes
country: United States
facility: Delaware Arthritis
state: Delaware
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Clearwater
country: United States
facility: Robert W. Levin, MD
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research Associates of Florida
state: Florida
city: Tavares
country: United States
facility: Kenneth Stark, MD
state: Florida
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Baltimore
country: United States
facility: Rheumatology Associates of Baltimore
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lansing
country: United States
facility: June DO, PC
state: Michigan
city: Lansing
country: United States
facility: Beals institute PC
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology, P.C.
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Timothy Kelly, MD
state: Nevada
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Midland Park
country: United States
facility: Prospect Medical Offices Valley Medical Group
state: New Jersey
city: Summit
country: United States
facility: Overlook Medical Center Wound Healing Center
state: New Jersey
city: Smithtown
country: United States
facility: Rheumatology Associates of Long Island
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Statesville
country: United States
facility: Carolina Specialty Care
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research, LLC
state: Ohio
city: Wheelersburg
country: United States
facility: Southern Ohio Rheumatology
state: Ohio
city: Duncansville
country: United States
facility: Dr. Alan Kivitz
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Health Specialist
state: South Carolina
city: Memphis
country: United States
facility: University of Tennesee Health Science
state: Tennessee
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Nassau Bay
country: United States
facility: Accurate Clinical Research
state: Texas
city: San Marcos
country: United States
facility: Arthritis Clinic of Central Texas
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic of Northern VA, PC
state: Virginia
city: Burke
country: United States
facility: Arthritis & Rheumatic Disease
state: Virginia
city: Bothell
country: United States
facility: Western Washington Arthritis Clinic
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, P.L.L.C
state: Washington
city: Onalaska
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
Study officials:
References: