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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT00777816
First received: October 17, 2008
Last updated: May 31, 2011
Last verified: May 2011

October 17, 2008
May 31, 2011
February 2009
October 2014   (final data collection date for primary outcome measure)
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events. [ Time Frame: Day 0 pre-dose through Day 56 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00777816 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic assessments from serum samples collected at time points specified in the protocol. [ Time Frame: Day 0 Pre-dose through Day 56 ] [ Designated as safety issue: No ]
  • Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 56 ] [ Designated as safety issue: No ]
  • Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 56 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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.
  • Drug: Placebo
    A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
  • Active Comparator: 1
    Intervention: Drug: XOMA 052
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
18
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00777816
X052070
No
Alan M. Solinger, M.D. / Medical Monitor; V.P. Clinical Immunology, XOMA (US) LLC
XOMA (US) LLC
Not Provided
Study Director: Alan Solinger, M.D. XOMA (US) LLC
XOMA (US) LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP