Effectiveness Intraarticular Corticosteroid | NCT01851278

Studies
Effectiveness Intraarticular Corticosteroid

NCT01851278

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

May 10, 2013Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

Triamcinolone hexacetonide
Triamcinolone hexacetonide

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Oct 2013Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

Apr 12, 2013

First Submission Date that Met QC Criteria

May 9, 2013

First Posted Date

May 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2013

Last Update Posted Date

May 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Daniele Freitas Pereira, Principal Investigator, Federal University of São PauloPrincipal Investigator

Lead Sponsor

Federal University of São PauloOTHER

Collaborators

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Background / Objectives: The optimal dose of corticosteroid to be used in intraarticular injection is not well established. The objective of this study is to compare the effectiveness and tolerance in the medium-term between small and large dose of triamcinolone hexacetonide (TH) used in intraarticular injection (IAI) of medium size joint of patients with rheumatoid arthritis (RA). Materials/Methods: A controlled, randomized, prospective, double-blind study will be realized in patients with RA. It will be evaluated 60 wrists joints (representing medium size joints) from the outpatient clinics at the Rheumatology Division UNIFESP, Brazil. Inclusion criteria were: 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. Patients with overlap syndromes, polyarticular synovitis, diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection were excluded. Patients will be randomized (Clapboard randomization) in two groups of 30 patients each: group 1 (high dose) is injected with 40mg (2ml) of TH and group 2 (small dose) was injected 20mg (1ml). Only one joint is injected by patient (IAI blindly). Evaluation will be conducted by a blinded observer at five times: baseline (T0), one week (T1), four (T4), eight (T8) and twelve (T12) weeks and the following assessment instruments were used: visual analogue scale for pain and swollen (VAS 0-10cm); wrist goniometry; chronic disease activity index (CDAI). Side effects and related events were reported in a medical questionnaire. The level of statistical significance was 5%.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Triamcinolone hexacetonide	Drug	High dose means 40mg or 2ml of triamcinolone hexacetonide	high dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale (VAS)		up to 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
chronic disease activity index (CDAI)		up to 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniele F Pereira, MsC	Universidade Federal de São Paulo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal de São Paulo	Recruiting	São Paulo	São Paulo	04024002	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19473560	Result	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.

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases