NCT01639287

Brief Summary

There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings. A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

July 10, 2012

Last Update Submit

July 11, 2012

Conditions

- Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Sonographic power Doppler

    baseline

Secondary Outcomes (1)

  • Sonographic Gray Scale

    baseline

Study Arms (2)

Painless

Painless synovitis group(called "cold" synovitis)

Painful

Painful synovitis group

Eligibility Criteria

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

Federal University of São Paulo ambulatory (Unifesp) and basic helth unit

You may qualify if:

  • longstanding rheumatoid arthritis
  • chronically painless synovitis in the hands or painful

You may not qualify if:

  • uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
  • change of basic drug in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023900, Brazil

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniele F Pereira, Dr

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele F Pereira

CONTACT

+55 11 96088607danisfreits22@yahoo.com.br

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Principal Investigator

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

BR(1)