Arthritis, RheumatoidPhase 2NCT00379990
A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.
A Phase 2 study testing GW274150 and Prednisolone in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- GW274150 and Prednisolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2006to Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
- Female subjects who are not capable of becoming pregnant
- Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness
- Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment
- Patients receiving methotrexate must be on stable folate supplements
- Must have been on stable doses for 2 weeks prior to screening if using COX inhibitors
- Signed consent form
- The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Who cannot join
- The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
- The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
- The subject received their final dose of infliximab or adalimumab within 3 months of enrollment
- The subject received their final dose of etanercept or anakinra within 1 month of enrollment
- The subject has received another investigational drug within 30 days
- The subject drinks more than 28 units (male) or 21 units (female) of alcohol in a week
Show all 11Show fewer
- History of liver or renal disease in the 6 months prior to screening
- The subject has a history of drug or other allergy
- Subject is positive for Hepatitis B and C or HIV virus
- The subject has positive pregnancy test
- The subject has positive test for drugs of abuse
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.
This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- GW274150, Prednisolone, Placebo
- Keywords
- iNOS, Exhaled NO, Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW274150Drug
60 mg /day
PrednisoloneDrug
7.5 mg/day
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| GW274150 60 mg once daily for 28 days | Experimental | 60 mg GW274150 taken once daily for 28 days Receives: Drug: GW274150 |
| Prednisolone 7.5 mg once daily for 28 days | Active comparator | 7.5 mg prednisolone taken once daily for 28 days Receives: Drug: Prednisolone |
| Placebo once daily for 28 days | Placebo comparator | Placebo taken once daily for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment of synovial vascularity
Power Doppler ultrasonographic measurement of synovial vascularity
Measured: Day 1, Day 15 and Day 28
Secondary outcomes (7)
Synovial thickness
High frequency ultrasound measurement of synovial thickness
Measured: Day 1, 15 and 28
Safety: ECG
12-lead ECG meaurements
Measured: Day 1, 15 and 28
Safety: Vital Signs
Blood pressure and heart rate
Measured: Day 1, 15 and 28
Safety: Laboratory
Laboratory assessments including liver function tests, amylase and lipase
Measured: Day 1, 8, 15, 22, 28 and Follow Up
Pharmacokinetics: Cmax
Maximum plasma concentration of GW274150
Measured: Day 15 and Day 28
Pharmacokinetics: Trough
Trough plasma concentration of GW274150
Measured: Days 8,15 and Day 28
Tolerability
Adverse events
Measured: Day 1 to Day 28 and Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
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 Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379990
- Sponsor's protocol ID
- RA4104917
- Status last verified
- Jun 2012
- First submitted
- 21 Sep 2006
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Seymour M, Petavy F, Chiesa F, Perry H, Lukey PT, Binks M, Donatien PD, Freidin AJ, Eckersley RJ, McClinton C, Heath K, Prodanovic S, Radunovic G, Pilipovic N, Damjanov N, Taylor PC. Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):254-61. Epub 2012 Apr 13.
PubMed 22409880
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics and Effect on Synovial Thickness and Vascularity of 28 Days Repeat Dosing of GW274150 or 7.5mg Prednisolone in RA Subjects.
- ClinicalTrials.gov ID
- NCT00379990
- Acronym / sponsor ID
- RA4104917
- Conditions
- Arthritis, Rheumatoid
- Keywords
- iNOS, Exhaled NO, Rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Sep 2006 (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.
This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GW274150 60 mg once daily for 28 days | Experimental | Drug: GW27415060 mg GW274150 taken once daily for 28 days |
| Prednisolone 7.5 mg once daily for 28 days | Active comparator | Drug: Prednisolone7.5 mg prednisolone taken once daily for 28 days |
| Placebo once daily for 28 days | Placebo comparator | Other: PlaceboPlacebo taken once daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
- Female subjects who are not capable of becoming pregnant
- Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness
- Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment
- Patients receiving methotrexate must be on stable folate supplements
Key exclusion criteria (11 listed)
- The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
- The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
- The subject received their final dose of infliximab or adalimumab within 3 months of enrollment
- The subject received their final dose of etanercept or anakinra within 1 month of enrollment
- The subject has received another investigational drug within 30 days
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 |
|---|---|---|
| GW27415060 mg /day | Drug | GW274150 60 mg once daily for 28 days |
| Prednisolone7.5 mg/day | Drug | Prednisolone 7.5 mg once daily for 28 days |
| PlaceboPlacebo | Other | Placebo once daily for 28 days |
Primary outcome
Measurment of synovial vascularity
Time frame: Day 1, Day 15 and Day 28
Power Doppler ultrasonographic measurement of synovial vascularity
7 secondary outcomes
Synovial thickness
Time frame: Day 1, 15 and 28
Safety: ECG
Time frame: Day 1, 15 and 28
Safety: Vital Signs
Time frame: Day 1, 15 and 28
Safety: Laboratory
Time frame: Day 1, 8, 15, 22, 28 and Follow Up
Pharmacokinetics: Cmax
Time frame: Day 15 and Day 28
Pharmacokinetics: Trough
Time frame: Days 8,15 and Day 28
Tolerability
Time frame: Day 1 to Day 28 and Follow Up
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 2 Jul 2012.
- Derived from this study: PubMed 22409880Seymour M, Petavy F, Chiesa F, Perry H, Lukey PT, Binks M, Donatien PD, Freidin AJ, Eckersley RJ, McClinton C, Heath K, Prodanovic S, Radunovic G, Pilipovic N, Damjanov N, Taylor PC. Ultrasonographic measures of synovitis in an early phase clinical trial: a double-blind, randomised, placebo and comparator controlled phase IIa trial of GW274150 (a selective inducible nitric oxide synthase inhibitor) in rheumatoid arthritis. Clin Exp Rheumatol. 2012 Mar-Apr;30(2):254-61. Epub 2012 Apr 13.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW274150 and Prednisolone in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in 2 countries.
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 8 inclusion and 11 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 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Serbia, United Kingdom. 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?
Measurment of synovial vascularity (time frame: Day 1, Day 15 and Day 28). 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 NCT00379990, 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 2 Jul 2012.