Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT00777816
Last Updated: 2015-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE2
18 participants
INTERVENTIONAL
2009-02-28
Brief Summary
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It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
XOMA 052
A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
2
Placebo
A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
Interventions
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XOMA 052
A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
Placebo
A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe disease, defined as follows - At least six tender and six swollen joints (28 joint count) AND ESR \> 28 mm/hr or CRP \> 1.0 mg/dL
* Current duration of RA at Screening ≥ 6 months and ≤ 20 years
* RA and other medical conditions must be stable.
* Age ≥ 18 and ≤ 75 at Screening
* Weight ≥ 80 lbs (36.3 kg) and ≤ 275 lbs (125.0 kg)
* For females with child-bearing potential, a negative serum pregnancy test
Exclusion Criteria
* Joint replacement surgery within 60 days prior to Day 0 or joint replacement surgery planned within 9 months following Day 0
* Known HIV antibody, or hepatitis B surface antigen
* History of malignancy within 5 years prior to Screening other than carcinoma in situ of the cervix, or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin
* Immunodeficiency
* History or symptoms of a demyelinating disease
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 \< 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
* History of tuberculosis, positive PPD test, active atopic disease requiring medication, or asthma. A subject who has had a positive PPD test but has completed a course of treatment for tuberculosis, had a documented vaccination against tuberculosis, or had a negative QuantiFERON -TB test result is eligible.
* Chronic obstructive pulmonary disease (COPD), asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily
* Significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis)
* Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function. If the diagnosis of liver disease was based on positive Hep C serology due to prior vaccination, the subject is eligible.
* Pregnant or planning to become pregnant during the course of the study, or breast-feeding
18 Years
75 Years
ALL
No
Sponsors
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XOMA (US) LLC
INDUSTRY
Responsible Party
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XOMA (US) LLC
Principal Investigators
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Alan Solinger, M.D.
Role: STUDY_DIRECTOR
XOMA (US) LLC
Locations
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Clearwater, Florida, United States
Middleburg Heights, Ohio, United States
Countries
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Other Identifiers
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X052070
Identifier Type: -
Identifier Source: org_study_id