NCT02813083

Brief Summary

This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

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

Study Start

First participant enrolled

August 1, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

12.1 years

First QC Date

June 22, 2016

Last Update Submit

April 4, 2024

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • DAS28-ESR

    6 months

Study Arms (1)

Rheumatoid Arthritis

Rheumatoid arthritis patients

Other: No intervention (observational)

Interventions

No intervention (observational)OTHER

No intervention (observational)

Rheumatoid Arthritis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators will enroll 155 rheumatoid arthritis patients from the University of Minnesota Rheumatology clinics.

You may qualify if:

  • Diagnosis of rheumatoid arthritis

You may not qualify if:

  • Use of rituximab immediately prior to visit
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Department of Medicine

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel Mueller, M.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

August 1, 2011

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)