A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood - Full Text View

Sponsors and Collaborators:	Imperial College London Merck Sharp & Dohme
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00781469

Purpose

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
Rheumatoid Arthritis

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Whether peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining). [ Time Frame: Initial visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood and synovium

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
A 12 treatment naive patients who fulfil the ACR criteria for RA with active disease defined by a Disease Activity Score(DAS)28 score of more than 3.2.
B 6 RA patients in remission on a stable dose of methotrexate with a DAS28 score lower than 2.6
C 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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781469

Contacts

Contact: Peter C Taylor, MBBS, MA, PhD	0044 20 8383 4474	peter.c.taylor@imperial.ac.uk
Contact: Sonya Abraham, MBBS, PhD	0044 20 8383 4114	s.abraham@imperial.ac.uk

Locations

United Kingdom
The Kennedy Clinical Trials Unit, 4 West, Charing Cross Hospital, Fulham Palace Road
London, United Kingdom, W6 8RF

Sponsors and Collaborators

Imperial College London

Merck Sharp & Dohme

Investigators

Principal Investigator:

Peter C Taylor, PhD

Imperial College London

More Information

Publications:

Mantel N. The detection of disease clustering and a generalized regression approach. Cancer Res. 1967 Feb;27(2):209-20. No abstract available.

Responsible Party:	Imperial College, London, SW7 2AZ ( Gary Roper, Research Governance Manager )
Study ID Numbers:	112009
Study First Received:	October 28, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00781469
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Rheumatoid arthritis
RNA
Synovium
Peripheral blood mononuclear cells

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009