Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Study Overview
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Brief Summary
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Study X052070 will evaluate the safety and pharmacokinetics (PK) of XOMA 052 administered to patients with active, stable, moderate to severe rheumatoid arthritis (RA). It is hypothesized that administration of XOMA 052 is likely to improve inflammatory control in subjects with RA.

Official Title
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A Blinded, Placebo-controlled, Study of the Safety and Pharmacokinetics of XOMA 052 Administered to Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: XOMA 052
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American College of Rheumatology (ACR) diagnostic criteria for RA 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: Major surgery within 28 days prior to Day 0 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: XOMA 052<br>* A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. |  | Day 0 pre-dose through Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessments from serum samples collected at time points specified in the protocol. |  | Day 0 Pre-dose through Day 56 | 
| Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol. |  | Day 0 pre-dose through Day 56 | 
| Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol. |  | Day 0 pre-dose through Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid, Arthritis