NCT00777816

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
18

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

5.7 years

First QC Date

October 17, 2008

Last Update Submit

December 28, 2015

Conditions

Rheumatoid Arthritis

Keywords

RheumatoidArthritis

Outcome Measures

Primary Outcomes (1)

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

    Day 0 pre-dose through Day 56

Secondary Outcomes (3)

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

    Day 0 Pre-dose through Day 56

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

    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.

    Day 0 pre-dose through Day 56

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: XOMA 052

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

XOMA 052DRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Clearwater, Florida, 33765, United States

Location

Unknown Facility

Middleburg Heights, Ohio, 44130, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

gevokizumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Alan Solinger, M.D.

    XOMA (US) LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 17, 2008

First Posted

October 22, 2008

Study Start

February 1, 2009

Primary Completion

October 1, 2014

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

US(2)