Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00777816|
Recruitment Status : Suspended
First Posted : October 22, 2008
Last Update Posted : December 29, 2015
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|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||
A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
- 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 ]
- Pharmacokinetic assessments from serum samples collected at time points specified in the protocol. [ Time Frame: Day 0 Pre-dose through Day 56 ]
- Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol. [ Time Frame: Day 0 pre-dose through Day 56 ]
- 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 ]
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
|United States, Florida|
|Clearwater, Florida, United States, 33765|
|United States, Ohio|
|Middleburg Heights, Ohio, United States, 44130|
|Study Director:||Alan Solinger, M.D.||XOMA (US) LLC|