NCT00056602

Brief Summary

This study will explore how patients with rheumatoid arthritis evaluate, or rate, symptom improvements. Physicians generally evaluate patients health and treatment benefits based on laboratory measures, such as the number of tender or swollen joints, duration of morning stiffness, grip strength, pain severity and others. Less attention is given to whether these treatment results are meaningful to patients. This study will examine how much of an improvement in pain, stiffness, function, and other symptoms is needed before patients consider the change an important improvement. Patients 18 years of age or older who were diagnosed with rheumatoid arthritis after age 16 and who have active arthritis (6 or more tender joints) may be eligible for this study. Of particular interest are patients beginning treatment with prednisone, methotrexate, leflunomide, infliximab, or etanercept, although patients receiving any type of treatment may be included. Participants will be evaluated twice at the NIH Clinical Center, once at the start of the study and again at either 1 month or 4 months later, depending on the individual s treatment regimen. Permission will also be requested to review patients medical records for results of previous blood tests and x-rays. At each NIH visit, patients will undergo the following tests and procedures:

  • Medical history and physical examination, including evaluation of joint swelling and tenderness;
  • Questionnaires about rheumatoid arthritis symptoms;
  • Computer-based exercise to assess preferences for various state-of-health choices;
  • Grip strength test;
  • Walking test on level ground, with or without the use of a cane or walker;
  • Blood test to measure inflammation. At the second visit, in addition to the above procedures, participants will complete a questionnaire to rate the importance of changes, if any, in pain, morning stiffness, fatigue, joint swelling, functioning, worry, depression, and overall impressions, since the first visit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2003

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

March 18, 2003

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 19, 2003

Completed
Same day until next milestone

First Posted

Study publicly available on registry

March 19, 2003

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

15 years

First QC Date

March 19, 2003

Last Update Submit

January 3, 2020

Conditions

Rheumatoid Arthritis

Keywords

UtilityHealth StatusPreferencesResponse CriteriaTreatmentRheumatoid ArthritisRA

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be recruited by physician referral and self-referral.
  • A diagnosis of RA;
  • Age 18 years or older;
  • Onset of arthritis after the age of 16 years;
  • Active arthritis, as evidenced by six or more tender joints

You may not qualify if:

  • Inability to provide informed consent.
  • Children will necessarily be excluded from this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Paulus HE, Egger MJ, Ward JR, Williams HJ. Analysis of improvement in individual rheumatoid arthritis patients treated with disease-modifying antirheumatic drugs, based on the findings in patients treated with placebo. The Cooperative Systematic Studies of Rheumatic Diseases Group. Arthritis Rheum. 1990 Apr;33(4):477-84. doi: 10.1002/art.1780330403.

    PMID: 2109613BACKGROUND

  • van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum. 1996 Jan;39(1):34-40. doi: 10.1002/art.1780390105.

    PMID: 8546736BACKGROUND

  • Ward MM. Response criteria and criteria for clinically important improvement: separate and equal? Arthritis Rheum. 2001 Aug;44(8):1728-9. doi: 10.1002/1529-0131(200108)44:83.0.CO;2-J. No abstract available.

    PMID: 11508421BACKGROUND

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

  • Michael M Ward, M.D.

    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2003

First Posted

March 19, 2003

Study Start

March 18, 2003

Primary Completion

March 1, 2018

Study Completion

December 23, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

US(1)