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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832297
• Other study ID #: 088-CL-01
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2022

Study information

• Verified date: July 2017
• Source: Crescendo Bioscience
• Contact: David Chernoff, MD
• Phone: 650-351-3056
• Email: dchernoff[@]crescendobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid

Intervention

Other:
• Vectra DA

• Usual Care

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Arthritis Clinic of Northern VA, PC	Arlington	Virginia
United States	Rheumatology Associates of Baltimore	Baltimore	Maryland
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Western Washington Arthritis Clinic	Bothell	Washington
United States	Graves Gilbert Clinic	Bowling Green	Kentucky
United States	Arthritis & Rheumatic Disease	Burke	Virginia
United States	Dana Copeland Redyy Rheumatology	Chula Vista	California
United States	Robert W. Levin, MD	Clearwater	Florida
United States	Medvin Clinical Research	Covina	California
United States	Western Connecticut Health Network	Danbury	Connecticut
United States	Dr. Alan Kivitz	Duncansville	Pennsylvania
United States	Rheumatology Associates of North Alabama PC	Huntsville	Alabama
United States	Beals institute PC	Lansing	Michigan
United States	June DO, PC	Lansing	Michigan
United States	Timothy Kelly, MD	Las Vegas	Nevada
United States	Delaware Arthritis	Lewes	Delaware
United States	University of Tennesee Health Science	Memphis	Tennessee
United States	Southwest Rheumatology Research LLC	Mesquite	Texas
United States	Paramount Medical Research, LLC	Middleburg Heights	Ohio
United States	Prospect Medical Offices Valley Medical Group	Midland Park	New Jersey
United States	Carolina Health Specialist	Myrtle Beach	South Carolina
United States	Accurate Clinical Research	Nassau Bay	Texas
United States	Gundersen Clinic, Ltd.	Onalaska	Wisconsin
United States	Arthritis Research Associates of Florida	Palm Harbor	Florida
United States	Shores Rheumatology, P.C.	Saint Clair Shores	Michigan
United States	PMG Research of Salisbury	Salisbury	North Carolina
United States	Arthritis Clinic of Central Texas	San Marcos	Texas
United States	The Polyclinic	Seattle	Washington
United States	Rheumatology Associates of Long Island	Smithtown	New York
United States	Arthritis Northwest, P.L.L.C	Spokane	Washington
United States	Carolina Specialty Care	Statesville	North Carolina
United States	Overlook Medical Center Wound Healing Center	Summit	New Jersey
United States	Kenneth Stark, MD	Tavares	Florida
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Howard University	Washington	District of Columbia
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Southern Ohio Rheumatology	Wheelersburg	Ohio
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Clinical Research Center of Reading, LLC	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Crescendo Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of subjects with low disease activity (DAS28 <3.2) at Month 6		Baseline to 6 months
Other	Percentage of subjects with low disease activity (DAS28 <3.2) at Month 12		Baseline to 12 months
Other	Percentage of subjects with EULAR response at Month 6		Baseline to 6 months
Other	Percentage of subjects with EULAR response at Month 12		Baseline to 12 months
Other	Percentage of subjects with ACR50 response at Month 6		Baseline to 6 months
Other	Percentage of subjects with ACR50 response at Month 12		Baseline to 12 months
Other	Change in mTSS at Month 12		Baseline to 12 months
Other	Change in HAQ-DI score at Month 12		Baseline to 12 months
Other	Percentage of subjects with SAE		Baseline to 12 months
Other	Change in work productivity as measured by the WPS-RA at Month 6		Baseline to 6 months
Other	Change in work productivity as measured by the WPS-RA at Month 12		Baseline to 12 months
Other	Change in health related QOL as measured by SF-36 at Month 6		Baseline to 6 months
Other	Change in health related QOL as measured by SF-36 at Month 12		Baseline to 12 months
Other	Change in health related QOL as measured by EQ-5D-5L at Month 6		Baseline to 6 months
Other	Change in health related QOL as measured by EQ-5D-5L at Month 12		Baseline to 12 months
Other	Percentage of subjects Incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained at Month 12		Baseline to 12 months
Primary	Change in DAS28 at Month 6		Baseline to 6 months
Primary	Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6		Baseline to 6 months
Secondary	Percentage of subjects with ACR20 response at Month 6		Baseline to 6 months
Secondary	Change in HAQ-DI score at Month 6		Baseline to 6 months
Secondary	Percentage of subjects with radiographic non-progression at 12 months	Radiographic non-progression will be defined as change in modified total Sharp score (?mTSS) =0.5 units from baseline to Month 12	Baseline to 12 months
Secondary	Total cost of RA-related treatment, in US dollars, at Month 6		Baseline to 6 months
Secondary	Total cost of RA-related treatment, in US dollars, at Month 12		Baseline to 12 months