Study Stopped
struggled to recruit and the synovial tissue samples obtained were so poor that we had to end the study prematurely without data from the primary outcomes
A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
1 other identifier
observational
29
1 country
1
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 another. Understanding this relationship would be useful not only in potentially having a relatively non-invasive means to predict response to therapy but it might be useful in better understanding differences in RA expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 12, 2021
February 1, 2021
1.9 years
October 28, 2008
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining).
Initial visit
Secondary Outcomes (1)
Gene expression pattern of synovium in treatment naive rheumatoid arthritis patients correlates to that found in their circulating blood cells and if these are affected (or not)by disease modifying therapy (DMARD).
Visits 1, 2 and 3
Study Arms (3)
Naive patients
12 treatment naive patients who fulfil the American College of Rheumatology (ACR) criteria for RA with active disease defined by a Disease Activity Score (DAS)28 score of more than 3.2.
Patients in remission
6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6
Patients still have active disease
12 patients who fulfill the ACR criteria for RA and are being treated with methotrexate but still have active disease, defined as a DAS28 score of more than 3.2
Eligibility Criteria
Adult men and non-pregnant, non-lactating women between 18 and 75 years of age with a clinical history of rheumatoid arthritis.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, W6 8RF, United Kingdom
Biospecimen
Blood and synovium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter C Taylor, PhD
Imperial College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2008
First Posted
October 29, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 12, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share