Rheumatoid ArthritisNCT01851278
Effectiveness Intraarticular Corticosteroid
A study testing Triamcinolone hexacetonide in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the small and large dose of corticosteroid used in intraarticular injection of wrist. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Triamcinolone hexacetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with overlap syndromes
- polyarticular synovitis
- diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de São Paulo
São Paulo, São Paulo, 04024002
Daniele F Pereira, doctor, 55 11 55764239, danisfreitas22@yahoo.com.br
Daniele F Pereira, doctor
About this study
Official title: Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose
The purpose of this study is to compare the small and large dose of corticosteroid used in intraarticular injection of wrist.
Read the 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%.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Triamcinolone hexacetonide
- Keywords
- injection, arthritis, corticosteroid
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone hexacetonideDrug
High dose means 40mg or 2ml of triamcinolone hexacetonide
Triamcinolone hexacetonideDrug
Low dose means 20mg or 1 ml of triamcinolone hexacetonide
| Study group | Role | What they receive |
|---|---|---|
| high dose | Active comparator | intraarticular wrist injection of 40mg, 2ml Receives: Drug: Triamcinolone hexacetonide |
| low dose | Active comparator | intraarticular wrist injection of 20mg, 1ml. Receives: Drug: Triamcinolone hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Measured: up to 12 weeks
Secondary outcomes (1)
chronic disease activity index (CDAI)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Daniele Freitas Pereira, Federal University of São Paulo
- Investigators
- Daniele F Pereira, MsC, Principal investigator, Universidade Federal de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01851278
- Sponsor's protocol ID
- IIA- 3131- AR
- Status last verified
- Apr 2013
- First submitted
- 12 Apr 2013
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19473560
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Tolerance Infiltration Intraarticular Corticosteroid According to Dose
- ClinicalTrials.gov ID
- NCT01851278
- Acronym / sponsor ID
- IIA- 3131- AR
- Conditions
- Rheumatoid Arthritis
- Keywords
- injection, arthritis, corticosteroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 10 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose | Active comparator | Drug: Triamcinolone hexacetonideintraarticular wrist injection of 40mg, 2ml |
| low dose | Active comparator | Drug: Triamcinolone hexacetonideintraarticular wrist injection of 20mg, 1ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients with overlap syndromes
- polyarticular synovitis
- diabetes mellitus or uncontrolled hypertension and those with suspected local or systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone hexacetonideHigh dose means 40mg or 2ml of triamcinolone hexacetonide | Drug | high dose |
| Triamcinolone hexacetonideLow dose means 20mg or 1 ml of triamcinolone hexacetonide | Drug | low dose |
Primary outcome
Visual analog scale (VAS)
Time frame: up to 12 weeks
1 secondary outcome
chronic disease activity index (CDAI)
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2013.
- Results publication: PubMed 19473560Konai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniele F Pereira, MsC principal investigator
Universidade Federal de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone hexacetonide in people with Rheumatoid Arthritis, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01851278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2013.