Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00781469
First received: October 28, 2008
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

Blood and synovium


Enrollment: 29
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (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

Locations
United Kingdom
Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Merck
Investigators
Principal Investigator: Peter C Taylor, PhD Imperial College London
  More Information

Publications:

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00781469     History of Changes
Other Study ID Numbers: 112009
Study First Received: October 28, 2008
Last Updated: September 29, 2011
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 21, 2013