Effects of abatacept (Orencia®) on biomarkers in synovial tissue in patients with rheumatoid arthritis

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Males and females with a diagnosis of active rheumatoid arthritis (with a DAS28 CRP > 3,2) who have failed MTX therapy, with an inflamed knee, ankle or wrist joint.

Exclusion Criteria

Pregnancy, breastfeeding
subjects who are impaire, incapacitated or incapable of completing study related assessments
subjects who meet diagnostic criteria for any other rheumatic disease (e.g. lupus erythematous)
subjects who have previously received treatment with an investigational biologic RA therapy, antie-TNF theray, rituximab, tocilizumab or abatacept
subjects with active vasculitus of a major organ system with the exception of rheumatoid nodules
Subjects with current symptoms of severe, progressive, or uncontrolled renal,
hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or
cerebral disease, or other medical conditions that, in the opinion of the
investigator, might place the subject at unacceptable risk for participation in this
study.
Subjects with a history of cancer within the last five years (other than nonmelanoma
skin cell cancers cured by local resection). Existing non-melanoma
skin cell cancers must be removed prior to dosing.
Subjects who have clinically significant drug or alcohol abuse.
Subjects with any serious bacterial infection within the last 3 months, unless
treated and resolved with antibiotics, or any chronic bacterial infection (such as
chronic pyelonephritis, osteomyelitis and bronchiectasis).
Subjects at risk for tuberculosis (TB). Specifically, subjects with:
a) A history of active TB within the last 3 years even if it was treated
b) A history of active TB greater than 3 years ago unless there is documentation
that the prior anti-TB treatment was appropriate in duration and type
c) Current clinical, radiographic or laboratory evidence of active TB
d) Latent TB which was not successfully treated
Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2
months prior to signing informed consent.
Subjects with evidence (as assessed by the Investigator) of active or latent
bacterial or viral infections at the time of potential enrollment, including subjects
with evidence of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis
C infection detected during screening.
Subject who have received any live vaccines within 3 months of the anticipated
first dose of study medication or who will have need of a live vaccine at any time
following Day 1 of the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in synovial inflammation in serial biopsy samples following the<br /><br>administration of abatacept in patients with active rheumatoid arthritis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>clinical response<br /><br>cellular responses of synovial explants to inflammatory stimuli, and/or<br /><br>antagonists, before and after treatment with abatacept<br /><br>synovial biomarkers predictive of the clinical response to abatacept treatment<br /><br>the changes in phenotypes of peripheral blood mononuclear cells (PBMCs)</p><br>

Related Trials