Effectiveness Intraarticular Corticosteroid
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Triamcinolone hexacetonide
Triamcinolone hexacetonide
Sponsored by

About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring injection, arthritis, corticosteroid
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
Sites / Locations
- Universidade Federal de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high dose
low dose
Arm Description
intraarticular wrist injection of 40mg, 2ml
intraarticular wrist injection of 20mg, 1ml.
Outcomes
Primary Outcome Measures
Visual analog scale (VAS)
Secondary Outcome Measures
chronic disease activity index (CDAI)
Full Information
NCT ID
NCT01851278
First Posted
April 12, 2013
Last Updated
May 9, 2013
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01851278
Brief Title
Effectiveness Intraarticular Corticosteroid
Official Title
Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
injection, arthritis, corticosteroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high dose
Arm Type
Active Comparator
Arm Description
intraarticular wrist injection of 40mg, 2ml
Arm Title
low dose
Arm Type
Active Comparator
Arm Description
intraarticular wrist injection of 20mg, 1ml.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone hexacetonide
Intervention Description
High dose means 40mg or 2ml of triamcinolone hexacetonide
Intervention Type
Drug
Intervention Name(s)
Triamcinolone hexacetonide
Intervention Description
Low dose means 20mg or 1 ml of triamcinolone hexacetonide
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
chronic disease activity index (CDAI)
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele F Pereira, MsC
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele F Pereira, doctor
Phone
55 11 55764239
Email
danisfreitas22@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Daniele F Pereira, doctor
12. IPD Sharing Statement
Citations:
PubMed Identifier
19473560
Citation
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.
Results Reference
result
Learn more about this trial
Effectiveness Intraarticular Corticosteroid
We'll reach out to this number within 24 hrs