A Study to Evaluate BioMarkers in Blood Samples in Subjects With Rheumatoid Arthritis

Study to Evaluate Biomarkers in Blood and Synovial Fluid in Subjects With Rheumatoid Arthritis

The purpose of this study is to study the evaluation of blood samples and blood types to identify functional protein in the joints.

Study Overview

• Status: Completed
• Conditions: Arthritis
• Intervention / Treatment: Other: Blood samples; Other: Synovial fluid aspiration; Other: Synovial tissue sample

Detailed Description

Assessment of type I IFN signature in the peripheral blood and activation of type I IFN signaling pathway in synovial fluid (indicating expression of the functional IFN protein in the joints).

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Research Site
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
  • Tennessee
    • Jackson, Tennessee, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or Female Adults aged 18-75 years old

Description

Inclusion Criteria:

• Age 18 through 75 years at time of screening.
• Written informed consent and any locally required authorization (eg, HIPAA in the USA), obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
• A diagnosis of: a) Adult onset RA as defined by the 1987 ACR classification criteria (see Appendix 1), with at least 4 tender and 4 swollen joints at screening (Day 1). Tender/swollen joints must be a part of the 28-joint count included in the Disease Assessment Score 28 (DAS28) assessment; b) Osteoarthritis (OA) of the knee or acute pseudogout attack of the knee.
• Age ≥ 16 years at the time of onset of RA or onset of OA, pseudogout.
• Subjects should either not receive oral corticosteroids, or if receiving oral corticosteroids, need to be on a stable dose of oral prednisone (or equivalent) ≤ 10 mg/day for at least 4 weeks prior to screening (Day 1).
• Ability and willingness to complete the study until Day 120 as required by the protocol.

Exclusion Criteria:

• History or current inflammatory joint disease other than RA, OA, or pseudogout (eg, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other autoimmune disorder (systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, or overlap syndrome).
• Any neurological (congenital or acquired), psychiatric, vascular, or systemic disorder could also affect the evaluation of disease assessments; in particular, joint pain and swelling.
• Treatment with IFN-α or IFN-β.
• Intra-articular, IM, or IV corticosteroid injections within 28 days before screening (Day 1).
• Known history of or positive test result for human immunodeficiency virus (HIV).
• Serious infection (eg, pneumonia, septicemia) within the 2 months prior to Day 1 visit.
• Active bacterial or viral infection (which includes ongoing and/or chronic infections such as hepatitis, tuberculosis, etc).
• Concomitant use of systemic antiviral, antibiotic, or antifungals for the treatment of active infection within 28 days of Day 1.
• History of malignancy or evidence of active or suspected malignancy (with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix > 1 year before randomization into the study).
• Vaccinations within 4 weeks of Day 1 visit.
• Concurrent enrollment in another clinical study.
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
• Other unspecified reasons that, in the opinion of the Investigator or medical monitor, make the subject unsuitable for participation or confound the data.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rheumatoid Arthritis; Subject must have RA with inflamed joint	Other: Blood samples; Subjects will have visits on Days 1, 30 and 120.; Other: Synovial fluid aspiration; Subjects will have visits on Days 1, 30, and 120.; Other: Synovial tissue sample; Subjects will have visits on Days 1, 30, and 120.
Osteoarthritis; Subjects must have OA of the knee	Other: Blood samples; Subjects will have visits on Days 1, 30 and 120.; Other: Synovial fluid aspiration; Subjects will have visits on Days 1, 30, and 120.; Other: Synovial tissue sample; Subjects will have visits on Days 1, 30, and 120.
Pseudo gout; Subjects must have peusdo-gout of knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection and Analyses	Data analyses on model devlopment to maximize measures of predictive diagnostic accuracy, etc.	Study Day 120

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RNA Assessment	Level of signature protein, messenger RNA or micro RNA in peripheral blood and diseased tissue will also be assessed.	Day 120

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: AstraZeneca
• Investigators: Study Director: Warren Greth, MD, MedImmune LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 24, 2010
• First Submitted That Met QC Criteria: September 24, 2010
• First Posted (Estimate): September 27, 2010

Study Record Updates

• Last Update Posted (Estimate): July 25, 2013
• Last Update Submitted That Met QC Criteria: July 23, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CD-IA-INDP-1056