Effectiveness Intraarticular Corticosteroid

• ClinicalTrials.gov Identifier: NCT01851278
• Recruitment Status: Unknown
• First Posted: May 10, 2013
• Last Update Posted: May 10, 2013
• Sponsor: Federal University of São Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): Daniele Freitas Pereira, Federal University of São Paulo

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Triamcinolone hexacetonide	Not Applicable

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%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose
• Study Start Date: April 2013
• Estimated Primary Completion Date: October 2013
• Estimated Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: high dose; intraarticular wrist injection of 40mg, 2ml	Drug: Triamcinolone hexacetonide; High dose means 40mg or 2ml of triamcinolone hexacetonide
Active Comparator: low dose; intraarticular wrist injection of 20mg, 1ml.	Drug: Triamcinolone hexacetonide; Low dose means 20mg or 1 ml of triamcinolone hexacetonide

Outcome Measures

Primary Outcome Measures :

1. Visual analog scale (VAS) [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :

1. chronic disease activity index (CDAI) [ Time Frame: up to 12 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

Universidade Federal de São Paulo; Recruiting

São Paulo, SP, Brazil, 04024002

Contact: Daniele F Pereira, doctor 55 11 55764239 danisfreitas22@yahoo.com.br

Principal Investigator: Daniele F Pereira, doctor

Sponsors and Collaborators

Federal University of São Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Daniele F Pereira, MsC; Universidade Federal de São Paulo

More Information

Publications of Results:

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.

• Responsible Party: Daniele Freitas Pereira, Principal Investigator, Federal University of São Paulo
• ClinicalTrials.gov Identifier: NCT01851278
• Other Study ID Numbers: IIA- 3131- AR
• First Posted: May 10, 2013
• Last Update Posted: May 10, 2013
• Last Verified: April 2013

Keywords provided by Daniele Freitas Pereira, Federal University of São Paulo:

injection; arthritis; corticosteroid

Additional relevant MeSH terms:

Arthritis; Joint Diseases; Musculoskeletal Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action