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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209585
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : July 25, 2013
Information provided by (Responsible Party):
MedImmune LLC

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.

Condition or disease Intervention/treatment
Arthritis 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
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Evaluate Biomarkers in Blood and Synovial Fluid in Subjects With Rheumatoid Arthritis
Study Start Date : March 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.
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

Primary Outcome Measures :
  1. Data Collection and Analyses [ Time Frame: Study Day 120 ]
    Data analyses on model devlopment to maximize measures of predictive diagnostic accuracy, etc.

Secondary Outcome Measures :
  1. RNA Assessment [ Time Frame: Day 120 ]
    Level of signature protein, messenger RNA or micro RNA in peripheral blood and diseased tissue will also be assessed.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or Female Adults aged 18-75 years old

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209585

United States, Maryland
Research Site
Frederick, Maryland, United States, 21702
United States, Pennsylvania
Research Site
Wyomissing, Pennsylvania, United States, 19610
United States, Tennessee
Research Site
Jackson, Tennessee, United States
Sponsors and Collaborators
MedImmune LLC
Study Director: Warren Greth, MD MedImmune LLC

Additional Information:
Responsible Party: MedImmune LLC Identifier: NCT01209585     History of Changes
Other Study ID Numbers: CD-IA-INDP-1056
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: July 25, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases