Status:
TERMINATED
A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Brief Summary
Rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one an...
Detailed Description
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. The disease is characterised by inflammation of synovial tissue (ST) in multipl...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adult men and non-pregnant, non-lactating women between 18 and 75 years of age. Sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
- Body weight greater \>40 kg and \<120 kg with a body mass index (BMI) between 19-31 kg/m2
- Clinical history of rheumatoid arthritis as defined by ACR criteria
- Negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
- For populations B and C only
- Currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only DMARD (no changes in dosing regimen for 4 weeks prior to screening).
- Exclusion criteria
- History of an acute illness within 2 weeks prior to the study
- History of drug abuse within 2 years
- Donation of blood in excess of 500 mL within 56 days prior to the first dose of study medication
- For group A only
- Prior treatment with disease modifying anti-rheumatic agents or biologicals.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00781469
Start Date
November 1 2008
End Date
October 1 2010
Last Update
February 12 2021
Active Locations (1)
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1
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF