Draining PLN and Synovial Inflammation in RA Knee Joints Pre and Post Anti-TNF or B Cell Depletion Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Rochester.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Christopher Ritchlin, University of Rochester
ClinicalTrials.gov Identifier:
NCT01083563
First received: March 8, 2010
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to examine the effect of anti-TNF therapy on rheumatoid arthritis using magnetic resonance imaging (MRI) and ultrasound imaging.

Anti-TNF therapies include a group of medications such as Enbrel, Remicade and Humira that affect your body's inflammatory response. These medications are routinely prescribed for the treatment of rheumatoid arthritis.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Morphologic and Functional Relationship Between the Draining PLN and Synovial Inflammation in the Knee Joints of RA Patients Before and After Anti-TNF or B Cell Depletion Therapy

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Morphologic and functional relationship between the draining PLN and synovial inflammation in the knee joints of RA patients [ Time Frame: Week 0 (initial medication dose) and Week 8 (post medication dose) ] [ Designated as safety issue: No ]
    To examine the morphologic and functional relationship between the draining PLN and synovial inflammation in the knee joints of RA patients before and after therapy with TNF antagonists or B cell depletion therapy via MRI and Doppler ultrasound.

  • TNF inhibition on volume and CE in the PLN in RA patients by MRI versus Doppler ultrasound. [ Time Frame: Week 0 (initial medication dose) and Week 8 (post medication dose) ] [ Designated as safety issue: No ]
    To assess the effect of TNF inhibition on volume and CE in the PLN in RA patients by MRI, and compare the effectiveness of Doppler US to achieve the same outcome measures.

  • Effect of anti-CD20 therapy on volume and CE in the PLN in RA patients who "flare" [ Time Frame: Week 0 (initial medication dose) and Week 8 (post medication dose) ] [ Designated as safety issue: No ]
    To assess the effect of anti-CD20 therapy on volume and CE in the PLN in RA patients who are experiencing knee synovitis after a period of effective anti-TNF therapy


Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA inadequate response to methotrexate
Individuals with rheumatoid arthritis who have had an inadequate response to methotrexate and will be starting on an anti-TNF agent.
RA inadequate response to anti-TNF.
Individuals with rheumatoid arthritis who have had an inadequate response to an anti-TNF and will be be given a rituximab infusion.

  Show Detailed Description

  Eligibility

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

Male and female RA sufferers not less than 18 yrs of age who are currently experiencing knee synovitis. Racial and ethnic origin of subjects will be monitored to reflect the diversity of our community.

Criteria

Inclusion Criteria

  • Signed, IRB-approved, written informed consent
  • Subjects can be of either gender but must be more than 18 years old.
  • Subjects must fulfill the disease activity criteria for RA and a DAS28 will be assessed at baseline and at 2 months after rituximab therapy.
  • Aim A - Eligible subjects must meet criteria for RA and have an inadequate response to MTX defined as DAS28 >5.1. They must have been on a steady dose of MTX (between 15 and 20 mg /week for a minimum of 8 weeks). Subjects must have evidence of knee synovitis on exam to enter the study.
  • Aim B - Subjects must have demonstrated a response to a TNF antagonist as evidenced by a DAS score <2.8 or <4 tender and swollen joints. Flare will be defined as a DAS 28 >5.1 of more than 8 swollen and tender joints. Subjects must have evidence of knee synovitis to enter the study. Subjects will be off etanercept, infliximab or adalimumab for 4 weeks before starting BCDT. All subjects must also be on a stable dose of DMARD (MTX, leflunomide, azulfidine, hydroxychloroquine) for 8 weeks before entry into the study.

Exclusion Criteria

  • Patients will be excluded for medical or other reasons at the discretion of the investigators. The reasons for the exclusion must be recorded, e.g. risk of non-compliance, vulnerability, medically unstable, etc.
  • Active systemic disorders or inflammatory conditions (i.e., chronic infection with hepatitis B, hepatitis C or HIV) other than the conditions being studied.
  • Patients with a plasma creatinine > 1.5 mg/dl
  • Aim B - Subjects with an allergy to corticosteroids will be excluded from the study.
  • Anyone answering yes to the following questions will be excluded:

Do you have a history of:

  1. Cardiac (Heart) pacemaker or defibrillator?
  2. Cardiac (Heart) valve replacement or prosthesis?
  3. Aneurysm clips from brain surgery?
  4. Ear prosthesis (cochlear or stapedial implant)? (hearing aids?)
  5. Neurostimulator?
  6. Biostimulator?
  7. Any type of pumps in or on your body?
  8. Shrapnel, gunshot wound, BB pellet?
  9. Metallic penile prosthesis?
  10. Metallic blood vessel filter or stent?
  11. Orthopedic prosthesis?
  12. Have you ever had an injury involving metal fragments in your eye?
  13. Have you ever had neurosurgery (brain or skull surgery)?

Note: Subjects treated with rituximab will not be excluded from study based on their immunosuppressive drugs but use of these agents will be recorded and discussed in the analysis.

  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: NCT01083563

Contacts
Contact: Rick A. Barrett, MT / MBA 585-275-1647 rick_barrett@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Christopher Ritchlin, MD / MPH University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christopher Ritchlin, M.D., M.P.H., Professor of Medicine Allergy, Immunology & Rheumatology Division, University of Rochester
ClinicalTrials.gov Identifier: NCT01083563     History of Changes
Other Study ID Numbers: RSRB-27325
Study First Received: March 8, 2010
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
TNF
CD20
RA

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

ClinicalTrials.gov processed this record on August 01, 2014