A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.

Overview

No summary available.

Registry

who.int

Start Date

June 12, 2017

End Date

October 22, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Between 18 and 75 years of age inclusive, at the time of signing the informed consent.
•TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY
•2\. Subjects that do not have any medical conditions, other than moderate to severe RA, that in the opinion of the Investigator put the subject at unacceptable risk or interfere with study assessments or integrity of the data. These medical conditions should be stable at the time of screening and are expected to remain stable for the duration of the study.
•3\. Subject has had a confirmed diagnosis of rheumatoid arthritis according to the revised
•2010 American College of Rheumatology/European League Against Rheumatism ACR\-EULAR classification criteria.
•4\. Disease duration of \= 12 weeks (time from onset of patient\-reported symptoms of either pain or stiffness or swelling in hands, feet or wrists) at screening.
•5\. Swollen joint count of \=4 (28\-joint count) and tender joint count \= 4 (28\-joint count) at screening.
•6\. Subject has a DAS28 CRP disease activity score of \= 3\.2 and CRP \= 5\.0 mg/L ( \= 4\.76 nmol/L) at screening.
•7\. Subject must have received at least 12 weeks of non\-biologic DMARD monotherapy or methotrexate (MTX)/DMARD combination therapy prior to screening AND must be on stable dose throughout the study.
•8\. Subject is naive to any biological therapies for RA

•CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER
•FUNCTION AND QTc INTERVAL)
•1\. Subject with a positive anti\-double stranded deoxyribonucleic acid and confirmed diagnosis of systemic lupus erythematosus (SLE)
•2\. Subject with current history of Suicidal Ideation Behaviour (SIB) as measured using the Columbia Suicide Severity Rating Scale (C\-SSRS) or a history of attempted suicide
•3\. An active infection, or a history of infections as follows:
•\- Hospitalisation for treatment of infection within 60 days before first dose
•\- Currently on any suppressive therapy for a chronic infection
•\- Use of parenteral antibiotics for an infection within 60 days before first dose
•\- A history of opportunistic infections within 1 year of screening. This does not include infections that may occur in immunocompetent individuals, such as fungal nail infections or vaginal candidiasis, unless it is of an unusual severity or recurrent nature
•\- Recurrent or chronic infection or other active infection that, in the opinion of the Investigator might cause this study to be detrimental to the patient