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

Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209585
• Other study ID #: CD-IA-INDP-1056
• Status: Completed
• Phase: N/A
• First received: September 24, 2010
• Last updated: July 23, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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-a or IFN-ß.

• 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Blood samples
Subjects will have visits on Days 1, 30 and 120.
• Synovial fluid aspiration
Subjects will have visits on Days 1, 30, and 120.
• Synovial tissue sample
Subjects will have visits on Days 1, 30, and 120.

Locations

Country	Name	City	State
United States	Research Site	Frederick	Maryland
United States	Research Site	Jackson	Tennessee
United States	Research Site	Wyomissing	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
MedImmune LLC	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection and Analyses	Data analyses on model devlopment to maximize measures of predictive diagnostic accuracy, etc.	Study Day 120	No
Secondary	RNA Assessment	Level of signature protein, messenger RNA or micro RNA in peripheral blood and diseased tissue will also be assessed.	Day 120	No

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