Arthritis, RheumatoidPhase 2NCT00256919
Single Dose Study Of GW856553 On A Protein That Is An Indicator For Rheumatoid Arthritis (RA)
A Phase 2 study testing GW856553 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 17 sites in 5 countries.
Trial summary
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis 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?
- GW856553
- How many people
- 51 participants
- Where
- 17 sitesin 5 countries
- Study dates
- Nov 2005to Nov 2006
- 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
- Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
- Must have 3 or more swollen or 3 or more tender/painful joints at screening.
- Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.
Who cannot join
- Must not be morbidly obese.
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Ukraine5 sites
GSK Investigational Site
Donetsk, 83045
GSK Investigational Site
Kharkiv, 61002
GSK Investigational Site
Kiev, 01030
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Lviv, 79010
Germany4 sites
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, 24576
GSK Investigational Site
Erlangen, Bavaria, 91056
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 21075
GSK Investigational Site
Munich, Bavaria, 80639
Bulgaria3 sites
GSK Investigational Site
Plovdiv, 4000
GSK Investigational Site
Sofia, 1233
GSK Investigational Site
Sofia, 1431
Spain3 sites
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41071
Sweden2 sites
GSK Investigational Site
Linköping, SE-582 25
GSK Investigational Site
Uppsala, SE-753 23
About this study
Official title: A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship
This study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
- Conditions
- Arthritis, Rheumatoid
- Being tested
- GW856553
- Keywords
- GW856553, biomarkers, CRP, 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.
GW856553Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP) levels 72 hours post-dose.
Measured: 72 hours post-dose.
Secondary outcomes (1)
C-reactive protein (CRP) levels 24 and 48 hours post-dose
Measured: 24 and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2006
- Study completionNov 2006
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 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
- NCT00256919
- Sponsor's protocol ID
- RA3103730
- Status last verified
- Oct 2012
- First submitted
- 21 Nov 2005
- Last updated
- 5 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
PubMed 23254770
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Parallel Group Single Dose Study of GW856553 in Patients With Active RA to Investigate the C-Reactive Protein (CRP) Dose Response Relationship
- ClinicalTrials.gov ID
- NCT00256919
- Acronym / sponsor ID
- RA3103730
- Conditions
- Arthritis, Rheumatoid
- Keywords
- GW856553, biomarkers, CRP, rheumatoid arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 22 Nov 2005 (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 study is designed to compare a range of doses of GW856553 versus placebo on the biomarkers associated with rheumatoid arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
- Must have 3 or more swollen or 3 or more tender/painful joints at screening.
- Must be on stable weekly methotrexate (2.5mg-25mg) for at least eight weeks prior to screening.
Key exclusion criteria (1 listed)
- Must not be morbidly obese.
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 |
|---|---|---|
| GW856553 | Drug | – |
Primary outcome
C-reactive protein (CRP) levels 72 hours post-dose.
Time frame: 72 hours post-dose.
1 secondary outcome
C-reactive protein (CRP) levels 24 and 48 hours post-dose
Time frame: 24 and 48 hours post-dose
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 5 Nov 2012.
- Derived from this study: PubMed 23254770Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.
Related trials for Arthritis, Rheumatoid
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW856553 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 17 sites in 5 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 3 inclusion and 1 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 5 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Ukraine, Germany, Bulgaria, Spain, Sweden. 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?
C-reactive protein (CRP) levels 72 hours post-dose. (time frame: 72 hours post-dose.). 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 NCT00256919, 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 5 Nov 2012.