EUCTR2009-012055-19-GB
Active, not recruiting
Not Applicable
A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- GlaxoSmithKline Research & Development Limited
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or females between 18 and 75 years of age, inclusive
- •2\. Using acceptable contraception to ensure that no pregnancies occur during the course of the study and for at least 12 weeks after receiving the last dose for male subjects and for 32 weeks after receiving the last dose for female subjects (see Section 8\.1 of the protocol on contraception for more details)
- •3\. Body mass index within the range 18\.5 \- 35 kg/m2 inclusive
- •4\. Capable of giving informed consent and can comply with the study requirements and timetable
- •5\. In France, a subject will be eligible for inclusion in this study if he or she is affiliated with or a beneficiary of a social security category
- •6\. Diagnosis of RA according to the revised 1987 criteria of the ACR
- •7\. DAS28 disease activity score of greater than 3\.2 at screening and prior to dosing
- •8\. CRP level \>0\.5 mg/dL at screening and prior to dosing
- •9\. Inflamed knee or ankle (or whichever inflamed joint will be biopsied), as shown by clinical examination or ultrasound
- •10\. Has never received a biological (marketed compounds or experimental treatments) or has been treated with a biological and failed due to lack of efficacy (adequate wash\-out is required based on the half\-life of the previously administered biological; wash\-out time should be discussed with GSK Medical Monitor)
Exclusion Criteria
- •1\. Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12\-lead or Holter); at the discretion of the investigator
- •2\. Positive Hepatitis B surface antigen or Hepatitis C antibody at screening
- •3\. History of human immunodeficiency virus or other immunodeficiency disease at screening
- •4\. A history of elevated liver function tests on more than one occasion (ALT, AST and ALP \> 3 times the ULN; total bilirubin \> 1\.5 times the ULN) in the 6 months prior to screening
- •5\. Previous exposure or past infection caused by mycobacterium tuberculosis, unless adequately treated (documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
- •6\. An acute infection
- •7\. A history of repeated, chronic or opportunistic infections 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
- •8\. A history of malignancy, except for adequately treated, non\-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix (an exception would be adequately treated cancer \>10 years prior to screening; documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
- •9\. Calculated creatinine clearance\< 50mL/min
- •10\. Significant cardiac, pulmonary, metabolic, renal, hepatic or GI 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
Outcomes
Primary Outcomes
Not specified
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