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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00781469
• Other study ID #: 112009
• Status: Terminated
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United Kingdom	Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral blood markers from patients with rheumatoid arthritis correlate to findings on ultrasound images and synovium (joint lining).		Initial visit
Secondary	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