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CompletedNCT00116714Updated May 6, 2011

Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

An observational study in Rheumatoid Arthritis, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-06.

Sponsored by Amgen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,968
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Rheumatoid Arthritis

Keywords

  • rheumatoid arthritis
  • RA
  • DMARD
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 4,968 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,968 participants (actual)

Groups and cohorts

  • Observation

    Drug: DMARD

Interventions

  • DrugDMARD

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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20952478 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00116714
Lead sponsor
Amgen
Collaborators
Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Jul 1, 2005
Start date
Oct 2001
Primary completion
Dec 2007
Completion
Oct 2008
Last update
May 6, 2011

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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