Rheumatoid ArthritisPhase 2NCT00555230
Effects of HMG-coA Reductase Inhibitor on Rheumatoid Arthritis
A Phase 2 study testing Rosuvastatin in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is: 1. To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls. 2. To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness. 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, 18 years of age or older
- Clinical diagnosis of RA with a duration of at least 6 month
- Prednisolone < =10 mg/day
- NSAID or DMARD
- Informed consent
Who cannot join
- Little or no ability for self-care
- Type 1 diabetes mellitus
- Uncontrolled hypertension(> 160/95 mmHg)
- Total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
- History of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
- Current treatment with ACE inhibitor, angiotensin II receptor blockers or beta-blockers, lipid lowering drug, or contra-indication to statins
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- Current treatment of oral contraceptives, estrogen and progestin was allowed but patient not willing to stop during study
- Current treatment with antioxidant therapy (Vitamin C or multivitamin)
- Received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening
- Clinically significant renal disease(serum creatinine level ≥ 270 µmol/L) or aspartate aminotransferase(AST), alanine aminotransferase ALT), or creatine kinase (CK)≥ 2 X ULN
- Female of childbearing potential, unwilling to use adequate contraception during the study
- Current or recent (within the past 3 months) pregnancy and cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
The purpose of this study is:
- To evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
- To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
- To ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and pulse wave velocity (PWV).
Read the detailed description
150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. Controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the IMT and PWV assessments.
Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Secondary outcomes:
- Prevalence of premature atherosclerosis in RA patients compared to healthy controls in terms of the presence of plague and PWV.
- Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).
- Relation among PWV, ABI and AI in RA patients, and clinical significance of their combination.
- Determine which segment's PWV has a better relation with RA disease activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rosuvastatin, Placebo
- Keywords
- HMG-CoA reductase inhibitors, Crestor, Rosuvastatin
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called crestor
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
PlaceboDrug
Also called crestor
5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rosuvastatin Receives: Drug: Rosuvastatin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Measured: baseline,week24,week52
Secondary outcomes (1)
physical examination,blood pressure,pulse rate,and body weight measurements at each visit.Liver function and CK are performed at baseline,week 12,24 and 52.Correlation between clinical parameters,inflammatory markers and atherosclerosis.
Measured: baseline,week0,week3,week8,week12,week24,week36,week52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Edmund Kwok Ming Li, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555230
- Sponsor's protocol ID
- RA-2007-004
- Status last verified
- Dec 2008
- First submitted
- 7 Nov 2007
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HMG-coA Reductase Inhibitor on Progression of Carotid Intima-Media Thickness and Arterial Stiffness in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00555230
- Acronym / sponsor ID
- RA-2007-004
- Conditions
- Rheumatoid Arthritis
- Keywords
- HMG-CoA reductase inhibitors, Crestor, Rosuvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 8 Nov 2007 (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 evaluate the prevalence of preclinical atherosclerosis in Chinese patients with RA compared to healthy controls.
- To determine those clinical and biological measures that best predict the presence of plaque and increased arterial stiffness.
- To ascertain the efficacy and safety of rosuvastatin in the prevention of atherosclerosis in patients with RA measured by carotid intima-media thickness (IMT) and pulse wave velocity (PWV).
Detailed description
150 consecutive RA patients followed at the Rheumatology clinic of the Prince of Wales Hospital will be recruited for this double-blind, randomized, placebo-control trial. Patients were matched to 150 controls on the basis of age (within 5 years), sex, body mass index (+/-5Kg) and ethnicity for the cross sectional study on the prevalence of subclinical atherosclerosis. Controls were healthy individuals recruited from the same community who underwent similar imaging protocols of the IMT and PWV assessments.
Primary outcome is the improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Secondary outcomes:
- Prevalence of premature atherosclerosis in RA patients compared to healthy controls in terms of the presence of plague and PWV.
- Correlation between clinical parameters, inflammatory markers (CRP/hsCRP, TNF-alpha and IL-6) and atherosclerosis (evaluated by IMT, the presence of plaque and PWV).
- Relation among PWV, ABI and AI in RA patients, and clinical significance of their combination.
- Determine which segment's PWV has a better relation with RA disease activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RosuvastatinRosuvastatin |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women, 18 years of age or older
- Clinical diagnosis of RA with a duration of at least 6 month
- Prednisolone < =10 mg/day
- NSAID or DMARD
- Informed consent
Key exclusion criteria (12 listed)
- Little or no ability for self-care
- Type 1 diabetes mellitus
- Uncontrolled hypertension(> 160/95 mmHg)
- Total cholesterol > 240 mg/dl, current or recent (within the past 3 months)
- History of coronary bypass grafting, myocardial infraction within 28days, left ventricular dysfunction (ejection fraction < 40%), significant valvular heart disease
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 |
|---|---|---|
| RosuvastatinAlso: crestor5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks | Drug | 1 |
| PlaceboAlso: crestor5mg daily for 4 weeks then step up to 10mg or matching placebo for 52 weeks | Drug | 2 |
Primary outcome
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV.
Time frame: baseline,week24,week52
1 secondary outcome
physical examination,blood pressure,pulse rate,and body weight measurements at each visit.Liver function and CK are performed at baseline,week 12,24 and 52.Correlation between clinical parameters,inflammatory markers and atherosclerosis.
Time frame: baseline,week0,week3,week8,week12,week24,week36,week52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2011.
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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.
Edmund Kwok Ming Li, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin in people with Rheumatoid Arthritis, run by Chinese University of Hong Kong at 1 site in China.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 27 Jan 2011. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of atherosclerosis by Rosuvastatin therapy, evaluated by IMT and PWV. (time frame: baseline,week24,week52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2011.