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Arthritis, RheumatoidPhase 2NCT00393146

A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid Arthritis

A Phase 2 study testing GW856553 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to look at the safety, tolerability and effectiveness of 28 days of dosing of GW856553 in rheumatoid arthritis patients. 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
57 participants
Where
15 sitesin 3 countries
Study dates
Oct 2006to Jan 2008
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

  • The subject is male or female ≥ 18 years of age.
  • To be eligible, female subjects must have a negative pregnancy test (i.e. serum beta hCG test) and be of:
  • non-childbearing potential (i.e. physiologically incapable of becoming pregnant). This includes any female who is post-menopausal. For the purposes of this study, post menopausal is defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate, history of vasomotor symptoms. Postmenopausal status will be confirmed by serum FSH and oestradiol concentrations at screening. Surgical sterility will be defined as females who have had a hysterectomy and/or bilateral oophorectomy or tubal ligation. OR
  • childbearing potential and agrees to commit to one of the protocol-approved methods of contraception as detailed in Section 7.1.
  • Body weight ≥ 50 kg (110lbs) for males and ≥ 45 kg (99lbs) for females.
  • Body mass index (BMI) within the range 18.5-35.0 kg/m2 inclusive.
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  • The subject has a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR) (see Appendix 6).
  • The subject must have DAS28 ≥ 4.2 (DAS28 calculated using ESR).
  • The subject must have liver function (ALT, AST and total bilirubin) tests < 1.5 x ULN at screening.
  • The subject must have ALP < 2 x ULN at screening.
  • The subject must have normal serum folate levels at screening (folate supplements can be administered if required but this must be stable for 4 weeks prior to randomisation).
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
  • Signed and dated written informed consent prior to admission to the study.

Who cannot join

  • The subject has a three month prior history of regular alcohol consumption exceeding an average weekly intake of > 21 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of > 14 units (or an average daily intake of greater than 2 units) for females. 1 unit is equivalent to a half-pint (284mL) of beer/lager; 25mL measure of spirits or 125mL of wine; or a positive alcohol breath test at the screening visit.
  • The subject has any history of liver disease.
  • The subject has a positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of the start of the study.
  • The subject has a history of elevated liver function tests on more than one occasion (ALT, AST, and total bilirubin > 2 x ULN or ALP > 3 x ULN) in the past 7 months.
  • The subject is currently receiving a biological anti-rheumatic therapy.
  • The subject has failed more than one anti-TNFα biological therapy due to lack of efficacy.
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  • The subject received an anti-rheumatic biological therapy within 6 months (for i.v.
  • administered therapies with long half-lives e.g. infliximab) or 3 months (for subcutaneously administered therapies or iv administered therapies with short halflives e.g. adalimumab or etanercept) prior to randomisation.
  • The subject has received rituximab.
  • The subject is using oral prednisolone at doses > 10mg/day, methotrexate > 25 mg/week or sulphasalazine > 5g/day.
  • The subject's DMARD dosing regimen has changed during the 4 weeks prior to randomisation.
  • The subject's current DMARD regimen has changed significantly (i.e. likely to impact disease activity during the study period) within the 3 months prior to dosing e.g. addition of a DMARD, changes in dose of greater than 2.5mg for methotrexate.
  • The subject has received leflunomide for less than 6 months prior to randomisation.
  • The subject has failed more than 3 DMARDs.
  • The subject's NSAIDs, COX-2 inhibitors or glucocorticoid dosing regimen changes at any time during four weeks prior to randomisation.
  • The subject's statin dosing regimen has changed significantly during the 3 months prior to randomisation
  • The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial.
  • The subject has an acute infection or a history of repeated or chronic infections.
  • The subject has a history of active tuberculosis.
  • The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (> 2 yrs prior).
  • The subject has a history of HIV or other immunosuppressive disease.
  • The subject has participated in a clinical trial within the 3 months prior to the study onset for non-biological therapy; or within 6 months of a biological therapy.
  • The subject has Hb < 9 g/dL and platelet count < 150 000/mm3.
  • The subject has a calculated creatinine clearance less than 60mL/min (subjects with a calculated creatinine clearance ≥ 50mL/min but < 60mL/min may still be included in consultation with the GSK medical monitor, but will not be eligible for the gadolinium enhancement MRI scans).
  • The subject has uncontrolled diabetes or psoriasis.
  • The subject has had a joint injection with glucocorticoid within the previous 4 weeks.
  • The subject is pregnant or nursing.
  • The subject is receiving medication which in the opinion of the investigator and/or GSK medical monitor, would interfere with study procedures, objectives or compromise subject safety.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Russia7 sites

  • GSK Investigational Site

    Moscow, 109240

  • GSK Investigational Site

    Moscow, 115093

  • GSK Investigational Site

    Moscow, 115522

  • GSK Investigational Site

    Moscow, 119049

  • GSK Investigational Site

    Moscow, 630117

  • GSK Investigational Site

    Saint Pertersburg, 196247

  • GSK Investigational Site

    Yaroslavl, 150003

Other trials in Russia

Spain6 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Madrid, 28035

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Santiago de Compostela, 15706

Other trials in Spain

Romania2 sites

  • GSK Investigational Site

    Bucharest, 11172

  • GSK Investigational Site

    Bucharest, 20983

Other trials in Romania

About this study

Official title: A Randomized, Double Blind, Placebo Controlled Study to Investigate the Safety and Tolerability and Clinical Activity of 28 Days of Oral Repeat Dosing With GW856553 at 7.5mg BID in Subjects With Active Rheumatoid Arthritis on Stable Anti-rheumatic Therapy.

This study is designed to look at the safety, tolerability and effectiveness of 28 days of dosing of GW856553 in rheumatoid arthritis patients.

Being tested
GW856553
Keywords
Rheumatoid arthritis, MRI
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

    Study drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease activity score based on 28 joint count (DAS28) at the end of the study.

    Measured: at the end of the study.

Secondary outcomes (4)

  1. Adverse events, vitals signs, ECGs and clinical lab tests after 56 days.

    Measured: after 56 days.

  2. Plasma biomarkers after 56 days.

    Measured: after 56 days

  3. Population pharmacokinetics after 56 days

    Measured: after 56 days

  4. Gadolinium enhanced MRI scans after 56 days.

    Measured: after 56 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00393146
Sponsor's protocol ID
RA3103718
Status last verified
May 2015
First submitted
24 Oct 2006
Last updated
13 May 2015
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

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 15 sites in 3 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 13 inclusion and 28 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 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Russia, Spain, Romania. 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?

Disease activity score based on 28 joint count (DAS28) at the end of the study. (time frame: at the end of the study.). 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 NCT00393146, 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 13 May 2015.

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