Arthritis, RheumatoidPhase 2NCT00370435
Study Of 90mg Of GW274150 In Subjects Over 50 Years, Who Have Rheumatoid Arthritis (RA)
A Phase 2 study testing GW274150 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA) population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and elderly population have not yet been determined. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- GW274150
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2005to Sep 2005
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No clinically significant disease as determined by history, physical examination and screening investigations.
- RA subjects on methotrexate (7.5mg - 25mg per week)
- Body weight >50 kg for males and >45 kg for females, who are not morbidly obese
- Diagnosis of RA
- Active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness
- Stable doses of DMARDs (Disease-modifying anti-rheumatic drugs, which must include methotrexate and can also include but is not restricted to sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrolment
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- Must be on stable folate supplements
- Subjects using NSAIDs or Cox-2 inhibitors must have been on stable doses for 2 weeks prior to screening
- LFT functions (ALT, AST, ALP) = 1.5 x ULN at screening and which have been stable on at least 2 occasions in the 7 months prior to screening
- Must provide signed and dated written informed consent prior to admission to the study
- Ability to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening
- Pregnant or nursing women
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the subject unfit for the study
- Taking >10mg/day oral glucocorticoids
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- Currently receiving anti-rheumatic biological therapy
- Received their final dose of infliximab or adalimumab within 3 months of enrollment
- Received their final dose of etanercept or anakinra within 1 month of enrollment
- Has received an investigational drug or participated in any other NCE research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to enrol.ment
- Regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female.
- Has a screening QTc value of >430msec (males) or >450msec (females), PR interval outside the range 120 to 200msec or an ECG that is not suitable for QT measurements
- History of liver or renal disease in the 6 months prior to screening
- Current renal insufficiency (subject must have an estimated creatinine clearance less than50mL/min as estimated from the serum creatinine using the Cockroft-Gault formula
- Has donated a unit of blood within the previous month or intends to donate in the month after completing the study
- Has a history or drug or other allergy, which in the opinion of the physician responsible, contraindicates their participation
- History of, or risk factors for, HIV, Hepatitis B and Hepatitis C
- History of drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects.
This is a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA) population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and elderly population have not yet been determined. Therefore this study is designed to ensure that 90mg GW274150 will be safe and well-tolerated in this adult and elderly RA patient population on methotrexate. The assessments will include pharmacokinetics (PK), liver function tests and creatinine clearance.
This study will provide confidence that a single 90mg dose of GW274150 results in exposure in RA subjects similar to that expected from healthy volunteers and asthmatics.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- GW274150
- Keywords
- rheumatoid arthritis, safety, GW274150, pharmacokinetics, tolerability
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver function and creatinine clearance after single 90mg dose of GW274150
Secondary outcomes (1)
clinical laboratory tests assessment of adverse events ECGs vital signs and Pharmacokinetic data of elderly population
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT00370435
- Sponsor's protocol ID
- 104916
- Status last verified
- May 2017
- First submitted
- 17 Aug 2006
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of 90mg of GW274150 in Adult and Elderly RA Subjects.
- ClinicalTrials.gov ID
- NCT00370435
- Acronym / sponsor ID
- 104916
- Conditions
- Arthritis, Rheumatoid
- Keywords
- rheumatoid arthritis, safety, GW274150, pharmacokinetics, tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 31 Aug 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 a study of GW274150, an iNOS (inducible nitric oxide synthase) inhibitor to investigate safety, tolerability and pharmacokinetics (PK) in the rheumatoid arthritis (RA) population (greater than 50 years). Safety, tolerability and PK of GW274150 in an adult and elderly population have not yet been determined. Therefore this study is designed to ensure that 90mg GW274150 will be safe and well-tolerated in this adult and elderly RA patient population on methotrexate. The assessments will include pharmacokinetics (PK), liver function tests and creatinine clearance.
This study will provide confidence that a single 90mg dose of GW274150 results in exposure in RA subjects similar to that expected from healthy volunteers and asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- No clinically significant disease as determined by history, physical examination and screening investigations.
- RA subjects on methotrexate (7.5mg - 25mg per week)
- Body weight >50 kg for males and >45 kg for females, who are not morbidly obese
- Diagnosis of RA
- Active disease defined as DAS28 = 4.0 and at least one MCP joint with either detectable vascularity or thickness
Key exclusion criteria (18 listed)
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening
- Pregnant or nursing women
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined
- As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the subject unfit for the study
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 |
|---|---|---|
| GW274150 | Drug | – |
Primary outcome
Liver function and creatinine clearance after single 90mg dose of GW274150
1 secondary outcome
clinical laboratory tests assessment of adverse events ECGs vital signs and Pharmacokinetic data of elderly population
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 30 May 2017.
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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
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 GW274150 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 1 site in United Kingdom.
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 11 inclusion and 18 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 30 May 2017. 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 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. 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?
Liver function and creatinine clearance after single 90mg dose of GW274150. 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 30 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.