NCT00006333

Brief Summary

This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients. Additional imaging using sensitive MRI methods will be obtained in some patients. The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status. Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
697

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2000

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

October 3, 2000

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2000

Completed
20.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

20.4 years

First QC Date

October 4, 2000

Last Update Submit

March 11, 2021

Conditions

Keywords

Pathogenesis

Outcome Measures

Primary Outcomes (1)

  • Determine patterns of arthritis

    Evaluate natural history and disease trajectories in rheumatoid arthritis

    End of the study

Secondary Outcomes (8)

  • Confirmatory Studies In RA and related diseases

    End of the study

  • Co-culture experiments using synovial tissue and surgical cartilage specimens

    End of the study

  • MRI Imaging in RA and related diseases

    End of the study

  • Collection of DNA in RA and related diseases

    End of the study

  • Evaluation of early disability in RA and related diseases

    End of the study

  • +3 more secondary outcomes

Study Arms (1)

Subjects with known or suspected arthritis

Subjects with known or suspected arthritis will be evaluated longitudinally

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with known or suspected arthritis

You may qualify if:

  • No age limits.
  • History of inflammatory synovitis of at least one or more swollen joints.
  • Patient's ability and willingness to give informed consent or in the pediatric patients, the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.

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 Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • James D Katz, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2000

First Posted

October 5, 2000

Study Start

October 3, 2000

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations