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Effectiveness Intraarticular Corticosteroid

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

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%.

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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


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851278


Locations
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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
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Principal Investigator: Daniele F Pereira, MsC Universidade Federal de São Paulo
Publications of Results:
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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    Key Record Dates
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:
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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