Effectiveness Intraarticular Corticosteroid

Rheumatoid Arthritis Clinical Trial

Official title:

Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01851278
• Other study ID #: IIA- 3131- AR
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2013
• Last updated: May 9, 2013
• Start date: April 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2013
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Triamcinolone hexacetonide
High dose means 40mg or 2ml of triamcinolone hexacetonide
• Triamcinolone hexacetonide
Low dose means 20mg or 1 ml of triamcinolone hexacetonide

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines: Guidelines for the management of rheumatoid arthritis. Arthitis Rheum 2002;46:328-46. Thiele K et al. Current use of glucocorticoids in patients with rheumatoid arthritis in

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)		up to 12 weeks	Yes
Secondary	chronic disease activity index (CDAI)		up to 12 weeks	Yes