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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00777816
• Other study ID #: X052070
• Status: Suspended
• Phase: Phase 2
• First received: October 17, 2008
• Last updated: December 28, 2015
• Start date: February 2009

Study information

• Verified date: December 2015
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 18
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.		Day 0 Pre-dose through Day 56	No
Secondary	Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.		Day 0 pre-dose through Day 56	No
Secondary	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	No