NCT00346411

Brief Summary

This research is being done to help us learn about how different factors related to treatment affect rheumatoid arthritis (RA). This is not a treatment study. We will follow the patient for one year as he or she receives usual treatment from his or her rheumatologist. Up to 360 adults with RA may join this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

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

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2011

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

6.3 years

First QC Date

June 28, 2006

Last Update Submit

October 3, 2017

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritismoodadherencemedication

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals diagnosed with rheumatoid arthritis and receiving treatment for this condition from a rheumatologist

You may qualify if:

  • Males and females age 19 or older
  • Current active, adult-onset rheumatoid arthritis who meet American College of Rheumatology (ACR) criteria for RA and have: (ACR functional class I-III), defined as:
  • or more swollen or tender joints and
  • Morning stiffness of 45min or longer
  • OR judged by their rheumatologist to have active disease
  • No evidence of other inflammatory diseases (e.g., Crohn's, IBS)
  • Functional class I, II or III

You may not qualify if:

  • Individuals with significant cardiovascular disease (CHF, stroke, MI)
  • Unwilling to have medications monitored and/or comply with protocol
  • Not fluent in English
  • Planning to move from area within next year or change health insurance (which would preclude ongoing care by a Johns Hopkins rheumatologist)
  • Enrolled in study evaluating efficacy of new or existing RA medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Susan Bartlett, PhD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

  • Cynthia S Rand, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

September 1, 2005

Primary Completion

December 12, 2011

Study Completion

December 12, 2011

Last Updated

October 5, 2017

Record last verified: 2017-10

Locations

US(1)