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

NCT ID: NCT01209585

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 23 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-03-31

Brief Summary

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

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).

Conditions

Arthritis

Study Design

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

Study Groups

Rheumatoid Arthritis

Subject must have RA with inflamed joint

Blood samples

Intervention Type: OTHER

Subjects will have visits on Days 1, 30 and 120.

Synovial fluid aspiration

Intervention Type: OTHER

Subjects will have visits on Days 1, 30, and 120.

Synovial tissue sample

Intervention Type: OTHER

Subjects will have visits on Days 1, 30, and 120.

Osteoarthritis

Subjects must have OA of the knee

Blood samples

Intervention Type: OTHER

Subjects will have visits on Days 1, 30 and 120.

Synovial fluid aspiration

Intervention Type: OTHER

Subjects will have visits on Days 1, 30, and 120.

Synovial tissue sample

Intervention Type: OTHER

Subjects will have visits on Days 1, 30, and 120.

Pseudo gout

Subjects must have peusdo-gout of knee

No interventions assigned to this group

Interventions

Blood samples

Subjects will have visits on Days 1, 30 and 120.

Intervention Type: OTHER

Synovial fluid aspiration

Subjects will have visits on Days 1, 30, and 120.

Intervention Type: OTHER

Synovial tissue sample

Subjects will have visits on Days 1, 30, and 120.

Intervention Type: OTHER

Eligibility Criteria

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.

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

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Warren Greth, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Research Site

Frederick, Maryland, United States

Research Site

Wyomissing, Pennsylvania, United States

Research Site

Jackson, Tennessee, United States

Countries

United States

Other Identifiers

CD-IA-INDP-1056

Identifier Type: -

Identifier Source: org_study_id