Clinical trial NCT01209585: A Study to Evaluate BioMarkers in Blood Samples in Subjects With Rheumatoid Arthritis
Official title: Study to Evaluate Biomarkers in Blood and Synovial Fluid in Subjects With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2010-09-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or Female Adults aged 18-75 years old

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).

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.

Primary outcomes:
measure: Data Collection and Analyses
timeFrame: Study Day 120
Secondary outcomes:
measure: RNA Assessment
timeFrame: Day 120
Other outcomes:
Locations:
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Wyomissing
country: United States
facility: Research Site
state: Pennsylvania
city: Jackson
country: United States
facility: Research Site
state: Tennessee
Study officials:
affiliation: MedImmune LLC
name: Warren Greth, MD
role: STUDY_DIRECTOR
References: