NCT00116714

Brief Summary

The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
4,968

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2001

Longer than P75 for all trials

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

October 1, 2001

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 6, 2011

Status Verified

May 1, 2011

Enrollment Period

6.2 years

First QC Date

June 30, 2005

Last Update Submit

May 5, 2011

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisRADMARD

Study Arms (1)

Observation

Drug: DMARD

Interventions

DMARDDRUG

All subjects were required to initiate, add or change DMARD therapy at study entry.

Observation

Eligibility Criteria

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

Subjects with RA according to ACR criteria, and who are starting, adding or changing DMARD therapy, including biologics.

You may qualify if:

  • Fulfillment of the 1987 American Rheumatism Association criteria for RA
  • Currently requiring a new DMARD (change or addition)

You may not qualify if:

  • Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol
  • Nursing or pregnant women
  • Patients with active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.

    PMID: 20952478DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Antirheumatic Agents

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 1, 2005

Study Start

October 1, 2001

Primary Completion

December 1, 2007

Study Completion

October 1, 2008

Last Updated

May 6, 2011

Record last verified: 2011-05