Arthritis, RheumatoidPhase 2NCT00320450
SB-681323 In Subjects With Rheumatoid Arthritis
A Phase 2 study testing SB-681323 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 41 sites in 9 countries.
Trial summary
The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments. 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?
- SB-681323
- How many people
- 78 participants
- Where
- 41 sitesin 9 countries
- Study dates
- Nov 2005to Oct 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
- Females cannot be pregnant or lactating.
- Must use defined contraceptive methods if of child-bearing potential.
- BMI range: 18.5-35.0 kg/m2.
- Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
- If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
- If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
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- If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
- Must give informed consent.
- Must abstain from alcohol during the trial participation.
Who cannot join
- Non-responder on biological RA treatment.
- Has a positive alcohol screen.
- Any history of liver disease.
- Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
- Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
- Acute infection.
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- History of active tuberculosis.
- History of repeated or chronic infection.
- History of malignancy.
- History of HIV or other immunosuppressive diseases.
- Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.
- Uncontrolled diabetes or psoriasis.
Trial locations and contacts
41 sites in 9 countries.
41 sites in 9 countries
Germany9 sites
GSK Investigational Site
Augsburg, Bavaria, 86179
GSK Investigational Site
Frankfurt am Main, Hesse, 60433
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20249
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22081
GSK Investigational Site
Hofheim, Hesse, 65719
GSK Investigational Site
Kiel, Schleswig-Holstein, 24105
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23538
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
Spain8 sites
GSK Investigational Site
A Coruña, 15006
GSK Investigational Site
Baracaldo/Vizcaya, 48903
GSK Investigational Site
Granada, 18014
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Mérida, 6800
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41071
GSK Investigational Site
Valencia, 46017
Norway7 sites
GSK Investigational Site
Drammen, N-3004
GSK Investigational Site
Lillehammer, 2609
GSK Investigational Site
Oslo, N-0027
GSK Investigational Site
Oslo, N-0370
GSK Investigational Site
Sarpsborg, N-1723
GSK Investigational Site
Stavanger, N-4011
GSK Investigational Site
Tønsberg, N-3117
Italy5 sites
GSK Investigational Site
Benevento, Campania, 82100
GSK Investigational Site
Foggia, Apulia, 71100
GSK Investigational Site
Jesi (AN), The Marches, 60035
GSK Investigational Site
Pisa, Tuscany, 56126
GSK Investigational Site
Telese Terme (BN), Campania, 82100
United Kingdom5 sites
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU
GSK Investigational Site
London, SE1 9RT
GSK Investigational Site
Metropolitan Borough of Wirral, Merseyside, CH49 9PE
GSK Investigational Site
Sheffield, S10 2JF
GSK Investigational Site
Wigan, Lancashire, WN6 9EP
Poland3 sites
GSK Investigational Site
Grudziądz, 86-300
GSK Investigational Site
Warsaw, 02-341
GSK Investigational Site
Wroclaw, 50-088
Sweden2 sites
GSK Investigational Site
Gothenburg, SE-431 45
GSK Investigational Site
Luleå, SE-972 33
About this study
Official title: A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)
The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- SB-681323
- Keywords
- SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-681323Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.
Measured: 28 Days
Secondary outcomes (1)
Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startNov 2005
- Primary completionOct 2006
- Study completionOct 2006
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 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
- NCT00320450
- Sponsor's protocol ID
- RA1100849
- Status last verified
- May 2012
- First submitted
- 28 Apr 2006
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT00320450
- Acronym / sponsor ID
- RA1100849
- Conditions
- Arthritis, Rheumatoid
- Keywords
- SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 3 May 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.
The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.
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 (9 listed)
- Females cannot be pregnant or lactating.
- Must use defined contraceptive methods if of child-bearing potential.
- BMI range: 18.5-35.0 kg/m2.
- Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
- If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
Key exclusion criteria (12 listed)
- Non-responder on biological RA treatment.
- Has a positive alcohol screen.
- Any history of liver disease.
- Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
- Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
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 |
|---|---|---|
| SB-681323 | Drug | – |
Primary outcome
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo.
Time frame: 28 Days
1 secondary outcome
Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.
Time frame: 28 Days
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 4 Nov 2013.
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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
41 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-681323 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 41 sites in 9 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 9 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 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Germany, Spain, Norway, Italy, United Kingdom and 4 more countries. 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?
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo. (time frame: 28 Days). 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 4 Nov 2013.