Rheumatoid ArthritisPhase 2NCT00777816
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Active, Stable, Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing XOMA 052 in people with Rheumatoid Arthritis, run by XOMA (US) LLC at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- XOMA 052
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Clearwater, Florida, 33765
Study site
Middleburg Heights, Ohio, 44130
About this study
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 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- XOMA 052, Placebo
- Keywords
- Rheumatoid, Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XOMA 052Drug
A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
PlaceboDrug
A single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: XOMA 052 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by pre- and post-treatment serial measurements of vital signs, clinical laboratory assessments, and treatment-emergent adverse events.
Measured: Day 0 pre-dose through Day 56
Secondary outcomes (3)
Pharmacokinetic assessments from serum samples collected at time points specified in the protocol.
Measured: Day 0 Pre-dose through Day 56
Assessment of inflammatory markers CRP and ESR collected at time points specified in the protocol.
Measured: 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.
Measured: Day 0 pre-dose through Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Solinger, M.D., Study director, XOMA (US) LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777816
- Sponsor's protocol ID
- X052070
- Status last verified
- Dec 2015
- First submitted
- 17 Oct 2008
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00777816
- Acronym / sponsor ID
- X052070
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid, Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2014 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: XOMA 052 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XOMA 052A single dose of study drug on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection. | Drug | 1 |
| PlaceboA single dose of placebo on Day 0, administered either as an intravenous (IV) infusion or as a subcutaneous (SC) injection. | Drug | 2 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Solinger, M.D. study director
XOMA (US) LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XOMA 052 in people with Rheumatoid Arthritis, run by XOMA (US) LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.