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



Status:Suspended
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:February 2009

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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

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.


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
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