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

NCT ID: NCT00781469

Last Updated: 2021-02-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-10-31

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.

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Patients in remission

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter C Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

112009

Identifier Type: -

Identifier Source: org_study_id