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

XOMA

Status and phase

Suspended

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo

Drug: XOMA 052

Study type

Interventional

Funder types

Industry

Identifiers

NCT00777816

X052070

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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