Study on the Safety of Abatacept in Relapsing Polychondritis

Completed · Phase 1

Conditions studied: Relapsing Polychondritis

In brief

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.

Key facts

Study ID

NCT01272856

Run by

Benaroya Research Institute

People needed

4

Starts

2011-01-01

Expected to finish

2012-05-01

Last updated by the study team

2012-08-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• If receiving any of the following medications, has been on a stable dose for the durations indicated without intent to change throughout the study:
• Azathioprine, methotrexate, mycophenolate, leflunomide: 1 month
• Corticosteroids: 2 weeks
• Nonsteroidal anti-inflammatory drugs (NSAIDs): 1 week
• Age and Sex
• Men and women, greater than 18 years of age
• Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last dose of study drug to minimize the risk of pregnancy.
• Women of child bearing age include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
• Amenorrhea that has lasted for greater than 12 consecutive months without another cause, or
• For women with irregular menstrual periods who are taking hormone replacement therapy (HRT), a documented serum follicle-stimulating hormone (FSH) level of greater than 35 mIU/mL.

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.
• Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations.
• Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ. Existing non-melanoma skin cell cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
• Subjects who currently abuse drugs or alcohol.
• 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) detected during screening.
• Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
• Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
• Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
• Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; 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; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).
• Physical and Laboratory Test Findings
• Subjects must not be positive for hepatitis B surface antigen.

Where it is running

• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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