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

NCT01209585 | Completed

• 1 other identifier: CD-IA-INDP-1056
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Data Collection and Analyses

  Data analyses on model devlopment to maximize measures of predictive diagnostic accuracy, etc.

  Study Day 120

Secondary Outcomes (1)

• RNA Assessment

  Day 120

Study Arms (3)

Rheumatoid Arthritis

Subject must have RA with inflamed joint

Other: Blood samples; Other: Synovial fluid aspiration; Other: Synovial tissue sample

Osteoarthritis

Subjects must have OA of the knee

Other: Blood samples; Other: Synovial fluid aspiration; Other: Synovial tissue sample

Pseudo gout

Subjects must have peusdo-gout of knee

Interventions

Blood samples OTHER

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

Osteoarthritis; Rheumatoid Arthritis

Synovial fluid aspiration OTHER

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

Osteoarthritis; Rheumatoid Arthritis

Synovial tissue sample OTHER

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

Osteoarthritis; Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or Female Adults aged 18-75 years old

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead
• AstraZeneca: collaborator

Study Sites (3)

Research Site

Frederick, Maryland, 21702, United States

Location

Research Site

Wyomissing, Pennsylvania, 19610, United States

Location

Research Site

Jackson, Tennessee, United States

Location

MeSH Terms

Conditions

Arthritis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Warren Greth, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

US (3)