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

Primary Purpose

Rheumatoid Arthritis

Status

Suspended

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

XOMA 052

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid, Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.

Secondary Outcome Measures

Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.

Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.

Assessment of Rheumatoid Arthritis disease status by the collection of ACR (American College of Rheumatology) core criteria at time points specified in the protocol.

Full Information

NCT ID

NCT00777816

First Posted

October 17, 2008

Last Updated

December 28, 2015

Sponsor

XOMA (US) LLC

1. Study Identification

Unique Protocol Identification Number

NCT00777816

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Suspended

Study Start Date

February 2009 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

XOMA (US) LLC

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid, Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

XOMA 052

Intervention Description

A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.

Time Frame

Day 0 Pre-dose through Day 56

Title

Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.

Time Frame

Day 0 pre-dose through Day 56

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Solinger, M.D.

Organizational Affiliation

XOMA (US) LLC

Official's Role

Study Director

Facility Information:

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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