Clinical trial NCT00777816: Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid
Arthritis
Lead sponsor: XOMA (US) LLC
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
timeFrame: Day 0 pre-dose through Day 56
Secondary outcomes:
measure: Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.
timeFrame: Day 0 Pre-dose through Day 56
measure: Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.
timeFrame: Day 0 pre-dose through Day 56
measure: Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.
timeFrame: Day 0 pre-dose through Day 56
Other outcomes:
Locations:
city: Clearwater
country: United States
state: Florida
city: Middleburg Heights
country: United States
state: Ohio
Study officials:
affiliation: XOMA (US) LLC
name: Alan Solinger, M.D.
role: STUDY_DIRECTOR
References: