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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777816
Recruitment Status : Suspended
First Posted : October 22, 2008
Last Update Posted : December 29, 2015
Sponsor:
Information provided by:
XOMA (US) LLC

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: XOMA 052 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2009
Actual Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 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 Comparator: 2 Drug: Placebo
A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetic assessments from serum samples collected at time points specified in the protocol. [ Time Frame: Day 0 Pre-dose through Day 56 ]
  2. Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 56 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777816


Locations
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United States, Florida
Clearwater, Florida, United States, 33765
United States, Ohio
Middleburg Heights, Ohio, United States, 44130
Sponsors and Collaborators
XOMA (US) LLC
Investigators
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Study Director: Alan Solinger, M.D. XOMA (US) LLC
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Responsible Party: Alan M. Solinger, M.D. / Medical Monitor; V.P. Clinical Immunology, XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT00777816    
Other Study ID Numbers: X052070
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Keywords provided by XOMA (US) LLC:
Rheumatoid
Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases