- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393146
A Study To Investigate The Effect Of 28 Days Of Dosing With GW856553 On Patients With Rheumatoid Arthritis
May 11, 2015 updated by: GlaxoSmithKline
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
57
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bucharest, Romania, 11172
- GSK Investigational Site
-
Bucharest, Romania, 20983
- GSK Investigational Site
-
-
-
-
-
Moscow, Russian Federation, 119049
- GSK Investigational Site
-
Moscow, Russian Federation, 115522
- GSK Investigational Site
-
Moscow, Russian Federation, 109240
- GSK Investigational Site
-
Moscow, Russian Federation, 115093
- GSK Investigational Site
-
Moscow, Russian Federation, 630117
- GSK Investigational Site
-
St Pertersburg, Russian Federation, 196247
- GSK Investigational Site
-
Yaroslavl, Russian Federation, 150003
- GSK Investigational Site
-
-
-
-
-
La Coruña, Spain, 15006
- GSK Investigational Site
-
Madrid, Spain, 28007
- GSK Investigational Site
-
Madrid, Spain, 28046
- GSK Investigational Site
-
Madrid, Spain, 28034
- GSK Investigational Site
-
Madrid, Spain, 28035
- GSK Investigational Site
-
Santiago de Compostela, Spain, 15706
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- 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.
- 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.
Exclusion criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Disease activity score based on 28 joint count (DAS28) at the end of the study.
Time Frame: at the end of the study.
|
at the end of the study.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events, vitals signs, ECGs and clinical lab tests after 56 days.
Time Frame: after 56 days.
|
after 56 days.
|
Plasma biomarkers after 56 days.
Time Frame: after 56 days
|
after 56 days
|
Population pharmacokinetics after 56 days
Time Frame: after 56 days
|
after 56 days
|
Gadolinium enhanced MRI scans after 56 days.
Time Frame: after 56 days.
|
after 56 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
October 24, 2006
First Submitted That Met QC Criteria
October 24, 2006
First Posted (Estimate)
October 26, 2006
Study Record Updates
Last Update Posted (Estimate)
May 13, 2015
Last Update Submitted That Met QC Criteria
May 11, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA3103718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis, Rheumatoid
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
National Institute of Arthritis and Musculoskeletal...Children's Hospital Medical Center, CincinnatiCompleted
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedRheumatoid Arthritis | Juvenile Rheumatoid ArthritisUnited States
-
University of Missouri-ColumbiaCompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Universidad Autonoma de Nuevo LeonCompletedRheumatoId ArthritisMexico
-
Hamad Medical CorporationUnknownRHEUMATOID ARTHRITISQatar
Clinical Trials on GW856553
-
GlaxoSmithKlineCompletedArthritis, RheumatoidBulgaria, Spain, Ukraine, Germany, Sweden
-
GlaxoSmithKlineCompletedRheumatoid Arthritis | Atherosclerosis | Chronic Obstructive Pulmonary Disease (COPD)United States
-
GlaxoSmithKlineCompletedPain, NeuropathicSpain, Russian Federation, Sweden, Denmark, United Kingdom, Norway, Australia
-
GlaxoSmithKlineCompletedHealthy Subjects | Dyslipidaemia | DyslipidaemiasUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic Obstructive | Chronic Obstructive Pulmonary Disease (COPD)Germany
-
GlaxoSmithKlineCompletedAcute Coronary SyndromeUnited States, Netherlands, Canada, Germany, Australia, United Kingdom, India, Spain, Poland
-
Cambridge University Hospitals NHS Foundation TrustGlaxoSmithKline; University of Cambridge; Royal Brompton & Harefield NHS Foundation... and other collaboratorsCompletedChronic Obstructive Pulmonary DiseaseUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom
-
GlaxoSmithKlineCompletedDepressive Disorder, MajorBulgaria, United States, Germany, Russian Federation, Estonia
-
GlaxoSmithKlineCompletedCardiovascular Disease | AtherosclerosisUnited States