Study on the Safety of Abatacept in Relapsing Polychondritis
An Open-Label, Single-Center, Phase I Study on the Safety of Abatacept in Relapsing Polychondritis
1 other identifier
interventional
4
1 country
1
Brief Summary
The purpose of this study is to test the safety of the study drug abatacept and see what effects (good and bad) it has in patients with relapsing polychondritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 7, 2012
August 1, 2012
1.3 years
January 6, 2011
August 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events
24 Weeks
Secondary Outcomes (3)
Physician assessment of chondritis burden
24 Weeks
Acute phase reactants (ESR, CRP)
24 weeks
Patient and physician-reported outcome measures, including HAQ, SF-36, and Visual Analogue Scores
24 weeks
Study Arms (1)
Open Label Abatacept
EXPERIMENTALInterventions
125 mg pre-filled syringe for sub-q injection weekly.
Eligibility Criteria
You may qualify if:
- Signed Written Informed Consent
- Diagnosed with relapsing consisting of 2 major or 1 major + 2 minor criteria as follows:
- Major criteria
- Proven inflammatory episodes involving auricular cartilage
- Proven inflammatory episodes involving nasal cartilage
- Proven inflammatory episodes involving laryngotracheal cartilage
- Minor criteria
- Ocular inflammation (conjunctivitis, keratitis, episcleritis, uveitis)
- Hearing loss
- Vestibular dysfunction
- Seronegative inflammatory arthritis
- Active RPC based on at least one of the following:
- Active chondritis as defined as active inflammation, as observed by the Investigator, in auricular and/or nasal cartilage
- Active tracheal and/or pulmonary disease documented by abnormal spirometry or chest computed tomography
- Erythrocyte sedimentation rate ≥ 30 mm/hr or C-reactive protein ≥ 0.6 mg/dL
- +13 more criteria
You may not qualify if:
- Sex and Reproductive Status
- Women of child bearing age who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of study drug.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or before administration of abatacept.
- Target Disease Exceptions
- Fulfills American College of Rheumatology criteria for any other connective tissue disease, such as but not necessarily limited to systemic lupus erythematosus, systemic sclerosis (scleroderma), polymyositis or dermatomyositis, or rheumatoid arthritis, or possesses another distinct condition known to be associated with chondritis, such as Wegener's granulomatosis or Behcet's disease
- Use of cyclophosphamide, cyclosporine A or tacrolimus within one month or at any time during administration of study drug
- Use of biologic treatments within the timeframes indicated:
- Anti-CD20 monoclonal antibodies or other immune cell-depleting therapy in the last 6 months or without evidence of appropriate lineage reconstitution
- TNF antagonists, IL-1R antagonists, or co-stimulation modulators in the last 3 months
- Any prior treatment with stem cell transplantation or other myeloablative therapy
- Concomitant illness or disease activity which, in the opinion of the investigator, is likely to require significant additional immunosuppressive therapy (e.g. \> 40 mg daily oral prednisone for asthma) during the course of the study
- Medical History and Concurrent Diseases
- Subjects who are impaired, incapacitated, or incapable of completing study-related assessments.
- Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RPC and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benaroya Research Institutelead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (1)
Peng SL, Rodriguez D. Abatacept in relapsing polychondritis. Ann Rheum Dis. 2013 Aug;72(8):1427-9. doi: 10.1136/annrheumdis-2013-203319. Epub 2013 Apr 20. No abstract available.
PMID: 23606702DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 10, 2011
Study Start
January 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 7, 2012
Record last verified: 2012-08