NCT01851278

Brief Summary

The purpose of this study is to compare the small and large dose of corticosteroid used in intraarticular injection of wrist.

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 not_applicable rheumatoid-arthritis

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable rheumatoid-arthritis

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

April 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 10, 2013

Status Verified

April 1, 2013

Enrollment Period

6 months

First QC Date

April 12, 2013

Last Update Submit

May 9, 2013

Conditions

Rheumatoid Arthritis

Keywords

injectionarthritiscorticosteroid

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale (VAS)

    up to 12 weeks

Secondary Outcomes (1)

  • chronic disease activity index (CDAI)

    up to 12 weeks

Study Arms (2)

high dose

ACTIVE COMPARATOR

intraarticular wrist injection of 40mg, 2ml

Drug: Triamcinolone hexacetonide

low dose

ACTIVE COMPARATOR

intraarticular wrist injection of 20mg, 1ml.

Drug: Triamcinolone hexacetonide

Interventions

Triamcinolone hexacetonideDRUG

High dose means 40mg or 2ml of triamcinolone hexacetonide

high dose

Eligibility Criteria

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

You may qualify if:

  • patients with established RA
  • age between 18 and 65 years
  • disease modifying anti-rheumatic drugs (DMARDs) stable for at least 3 months
  • synovitis in wrist with pain visual analogic scale (VAS) between 4 and 8cm

You may not qualify if:

  • patients with overlap syndromes
  • polyarticular synovitis
  • diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04024002, Brazil

RECRUITING

Related Publications (1)

  • Konai MS, Vilar Furtado RN, Dos Santos MF, Natour J. Monoarticular corticosteroid injection versus systemic administration in the treatment of rheumatoid arthritis patients: a randomized double-blind controlled study. Clin Exp Rheumatol. 2009 Mar-Apr;27(2):214-21.

    PMID: 19473560RESULT

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

triamcinolone hexacetonide

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniele F Pereira, MsC

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2013

First Posted

May 10, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

May 10, 2013

Record last verified: 2013-04

Locations

BR(1)