Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
intraarticular injection
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, glucocorticoid, intraarticular injection, arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid Arthritis diagnosed for more than 6 months
- 18 and 65 years
- Functional class II or III according to the ACR criteria
- VAS for knee pain higher than 5
- Use of stable doses of oral corticosteroid for the last 30 days
- Use of stable doses of DMARDs for the last 3 months
- Active synovitis at least in one knee for at least the 30 days
Exclusion Criteria:
- Non-controlled diabetes mellitus or hypertension
- Bacterial infection of any site
- Blood coagulation disorders
- Skin lesion on the affected knee
- History of previous surgical procedure in the knee
- Use of intra-muscular glucocorticoid in the last 30 days
- Intra-articular injection in the last 3 months
- Knee injection in the last 6 months
Sites / Locations
- Rheumatology Division, Federal University of Sao Paulo
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
VAS for knee pain
Secondary Outcome Measures
side and adverse effects, safety
Full Information
NCT ID
NCT00506896
First Posted
July 20, 2007
Last Updated
July 20, 2007
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00506896
Brief Title
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients
Official Title
Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients: A Randomized Double-Blind Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of intra-articular glucocorticoid injection to its systemic use for treatment of knee synovitis in patients with Rheumatoid Arthritis
Detailed Description
A randomized double-blind controlled study was conducted including 60 patients with RA. Patients were randomized to receive either a single intra-articular knee injection with triamcinolone hexacetonide 60 mg and xylocaine chloride 2% (1 mL) associated to a single intramuscular injection of 1 mL of xylocaine chloride 2% (IAI group) or 1 mL of xylocaine chloride 2% by intra-articular injection and a intramuscular injection of triamcinolone acetonide 60 mg and xylocaine chloride 2% (1 mL) (IM group). Evaluations were performed at baseline and 1, 4, 8 and 12 weeks post-intervention. The following instruments were used: the ACR 20%, 50 and 70% improvement criteria; VAS for knee morning stiffness, pain and edema; knee circumference and goniometry; Likert's scale of improvement (IVAS); daily use of oral glucocorticoid and NSAIDs, blood pressure and adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, glucocorticoid, intraarticular injection, arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
intraarticular injection
Other Intervention Name(s)
Triancil®, Theracort®
Intervention Description
Triamcinolone hexacetonide 60mg(3ml)by intraarticular injection Triamcinolone acetonide 60mg (3ml)by intramuscular administration
Primary Outcome Measure Information:
Title
VAS for knee pain
Time Frame
12 weeks post intervention
Secondary Outcome Measure Information:
Title
side and adverse effects, safety
Time Frame
12 weeks post intervention
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:
Rheumatoid Arthritis diagnosed for more than 6 months
18 and 65 years
Functional class II or III according to the ACR criteria
VAS for knee pain higher than 5
Use of stable doses of oral corticosteroid for the last 30 days
Use of stable doses of DMARDs for the last 3 months
Active synovitis at least in one knee for at least the 30 days
Exclusion Criteria:
Non-controlled diabetes mellitus or hypertension
Bacterial infection of any site
Blood coagulation disorders
Skin lesion on the affected knee
History of previous surgical procedure in the knee
Use of intra-muscular glucocorticoid in the last 30 days
Intra-articular injection in the last 3 months
Knee injection in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique S Konai, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rita V Furtado, MD, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marla F Santos, MD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamil Natour, MD, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Rheumatology Division, Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
12. IPD Sharing Statement
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Links:
URL
http://www.unifesp.br
Description
Federal University of Sao Paulo
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Monoarticular Corticosteroid Injection Versus Systemic Administration in the Treatment of Rheumatoid Arthritis Patients
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