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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01209585
First received: September 24, 2010
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Arthritis
Other: Blood samples
Other: Synovial fluid aspiration
Other: Synovial tissue sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study to Evaluate Biomarkers in Blood and Synovial Fluid in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Data Collection and Analyses [ Time Frame: Study Day 120 ] [ Designated as safety issue: No ]
    Data analyses on model devlopment to maximize measures of predictive diagnostic accuracy, etc.


Secondary Outcome Measures:
  • RNA Assessment [ Time Frame: Day 120 ] [ Designated as safety issue: No ]
    Level of signature protein, messenger RNA or micro RNA in peripheral blood and diseased tissue will also be assessed.


Enrollment: 23
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or Female Adults aged 18-75 years old

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209585

Locations
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
AstraZeneca
Investigators
Study Director: Warren Greth, MD MedImmune LLC
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01209585     History of Changes
Other Study ID Numbers: CD-IA-INDP-1056
Study First Received: September 24, 2010
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014