NCT02382783

Brief Summary

The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

February 23, 2015

Last Update Submit

September 2, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisDisease ActivityFlareManagement of FlaresPfizer

Outcome Measures

Primary Outcomes (2)

  • Flare Occurrence

    The occurrence of flares over the follow-up time (flare rate). The Outcome Measures in Rheumatology(OMERACT-9) definition of flare will be applied to both groups to determine how many occurrences indicate worsening of disease activity, leading to initiation, change, or increase of therapy by RHCPs. This definition will allow for parallel comparisons of flare rates in both groups.

    Anticipated length of study is two years.

  • Flare-to-visit Time

    The flare-to-visit time will be compared between the two groups.

    Anticipated length of study is two years.

Secondary Outcomes (1)

  • Participant Satisfaction

    Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.

Study Arms (2)

FLARE Intervention Group

OTHER

In the FLARE Intervention Group, we ask that you participate in all of the following, over the course of two years: * Baseline Study Visit * Monthly: Complete FLARE Questionnaires, at home, and report results. The last question on this questionnaire will ask you if you feel you are having a flare of your disease. * FLARE Study Visit (if applicable): We will schedule you to be seen when/if you feel you are having a flare of your disease. * Follow-up Visits (minimum of every 6 months): These are done as the standard of care for your RA. * At one time-point, during your first return visit after the baseline visit you will have an examination by ultrasound * Patient Satisfaction Surveys at three time-points: Baseline, 1 year, 2 year Also, your rheumatology health care provider (RHCP) will be asked to participate in the study by completing three satisfaction surveys over the course of two years.

Other: FLARE Intervention Group

Standard of Care (SOC) Group

NO INTERVENTION

If you are randomized to the SOC Group, your care will not be any different than your usual care of rheumatoid arthritis (RA). You will be seen by a rheumatologist at a minimum of every six months, which is the standard of care for RA. Additionally (for research), we ask the following of you... * At one time-point, during your first return visit after the baseline visit you will have an examination by ultrasound * Patient Satisfaction Surveys at three time-points: Baseline, 1 year, 2 year Also, your rheumatology health care provider (RHCP) will be asked to participate in the study by completing three satisfaction surveys over the course of two years.

Interventions

FLARE Intervention GroupOTHER

Everything being completed in this group is also being completed in the Standard of Care (SOC) Group except for the following... The participants randomized to this group will be asked to complete FLARE Questionnaires on a monthly basis and will call us each month with their results. The last question on the questionnaire asks if the patient feels he/she is having a flare. If the patient says "yes" to this question, then the study coordinator will arrange for an appointment to be scheduled with a rheumatology health care provider at Mayo Clinic Rochester. The goal will be to have this appointment take place within seven days of the FLARE Questionnaire results being reported.

FLARE Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be ≥ 18 years of age.
  • Patient must have been seen by a rheumatology health care provider at least two times within the last 18 months at Mayo Clinic Rochester.
  • Patient must have rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
  • Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • Patient must be willing to return to Mayo Clinic Rochester for follow-up appointments and fill out questionnaires as outlined in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Bingham CO 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, Witter JP, Furst DE, Strand CV, Boers M, Alten RE. Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group). J Rheumatol. 2009 Oct;36(10):2335-41. doi: 10.3899/jrheum.090369. Epub 2009 Aug 14.

    PMID: 19684147BACKGROUND

  • Myasoedova E, Crowson CS, Giblon RE, McCarthy-Fruin K, Schaffer DE, Wright K, Matteson EL, Davis JM 3rd. Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial. Clin Rheumatol. 2019 Nov;38(11):3025-3032. doi: 10.1007/s10067-019-04664-5. Epub 2019 Jul 1.

    PMID: 31264032DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric L Matteson, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2015

First Posted

March 9, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2018

Study Completion

July 1, 2020

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

US(1)