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A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781469
Recruitment Status : Completed
First Posted : October 29, 2008
Last Update Posted : May 28, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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 multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. The contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. Ultrasonography is a powerful, non−invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.

Although RA 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.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood
Study Start Date : November 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

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.
6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6
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

Primary Outcome Measures :
  1. Whether peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining). [ Time Frame: Initial visit ]

Secondary Outcome Measures :
  1. Whether the 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). [ Time Frame: Visits 1, 2 and 3 ]

Biospecimen Retention:   Samples With DNA
Blood and synovium

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult men and non-pregnant, non-lactating women between 18 and 75 years of age with a clinical history of rheumatoid arthritis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00781469

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United Kingdom
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Merck Sharp & Dohme Corp.
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Principal Investigator: Peter C Taylor, PhD Imperial College London

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Responsible Party: Imperial College London Identifier: NCT00781469     History of Changes
Other Study ID Numbers: 112009
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: September 2011

Keywords provided by Imperial College London:
Rheumatoid arthritis
Peripheral blood mononuclear cells

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases