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

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ClinicalTrials.gov Identifier: NCT02832297
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Crescendo Bioscience

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Other: Vectra DA Other: Usual Care Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Outcomes Study: Vectra® DA Guided Care Compared to Usual Care
Actual Study Start Date : June 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

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



Primary Outcome Measures :
  1. Change in DAS28 at Month 6 [ Time Frame: Baseline to 6 months ]
  2. Percentage of subjects using any biologic DMARD or JAK inhibitor to Month 6 [ Time Frame: Baseline to 6 months ]

Secondary Outcome Measures :
  1. Percentage of subjects with ACR20 response at Month 6 [ Time Frame: Baseline to 6 months ]
  2. Change in HAQ-DI score at Month 6 [ Time Frame: Baseline to 6 months ]
  3. Percentage of subjects with radiographic non-progression at 12 months [ Time Frame: Baseline to 12 months ]
    Radiographic non-progression will be defined as change in modified total Sharp score (ΔmTSS) ≤0.5 units from baseline to Month 12

  4. Total cost of RA-related treatment, in US dollars, at Month 6 [ Time Frame: Baseline to 6 months ]
  5. Total cost of RA-related treatment, in US dollars, at Month 12 [ Time Frame: Baseline to 12 months ]

Other Outcome Measures:
  1. Percentage of subjects with low disease activity (DAS28 <3.2) at Month 6 [ Time Frame: Baseline to 6 months ]
  2. Percentage of subjects with low disease activity (DAS28 <3.2) at Month 12 [ Time Frame: Baseline to 12 months ]
  3. Percentage of subjects with EULAR response at Month 6 [ Time Frame: Baseline to 6 months ]
  4. Percentage of subjects with EULAR response at Month 12 [ Time Frame: Baseline to 12 months ]
  5. Percentage of subjects with ACR50 response at Month 6 [ Time Frame: Baseline to 6 months ]
  6. Percentage of subjects with ACR50 response at Month 12 [ Time Frame: Baseline to 12 months ]
  7. Change in mTSS at Month 12 [ Time Frame: Baseline to 12 months ]
  8. Change in HAQ-DI score at Month 12 [ Time Frame: Baseline to 12 months ]
  9. Percentage of subjects with SAE [ Time Frame: Baseline to 12 months ]
  10. Change in work productivity as measured by the WPS-RA at Month 6 [ Time Frame: Baseline to 6 months ]
  11. Change in work productivity as measured by the WPS-RA at Month 12 [ Time Frame: Baseline to 12 months ]
  12. Change in health related QOL as measured by SF-36 at Month 6 [ Time Frame: Baseline to 6 months ]
  13. Change in health related QOL as measured by SF-36 at Month 12 [ Time Frame: Baseline to 12 months ]
  14. Change in health related QOL as measured by EQ-5D-5L at Month 6 [ Time Frame: Baseline to 6 months ]
  15. Change in health related QOL as measured by EQ-5D-5L at Month 12 [ Time Frame: Baseline to 12 months ]
  16. Percentage of subjects Incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained at Month 12 [ Time Frame: Baseline to 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832297


Contacts
Contact: David Chernoff, MD 650-351-3056 dchernoff@crescendobio.com

  Show 40 Study Locations
Sponsors and Collaborators
Crescendo Bioscience

Responsible Party: Crescendo Bioscience
ClinicalTrials.gov Identifier: NCT02832297     History of Changes
Other Study ID Numbers: 088-CL-01
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases