OsteoarthritisPhase 2NCT01882491
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
A Phase 2 study testing gevokizumab in people with Osteoarthritis, run by XOMA (US) LLC at 23 sites in United States.
Trial summary
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- gevokizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 23 sitesUnited States
- Study dates
- May 2013to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hand osteoarthritis
- Joint tenderness and/or redness
- At least one erosion by X-ray (as determined by the central reader)
- Contraceptive measures adequate to prevent pregnancy during the study
Who cannot join
- History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
- History of gout, pseudogout, or hemochromatosis
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of recurrent or chronic systemic infections
- Known allergy to acetaminophen
- Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Study site
Austin, Texas
Study site
Charlottesville, Virginia
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Duncansville, Pennsylvania
Study site
Franklin, Wisconsin
Study site
Huntsville, Alabama
Study site
Miami, Florida
Study site
Norfolk, Virginia
Study site
Pinellas Park, Florida
Study site
Raleigh, North Carolina
Study site
Reno, Nevada
Study site
Roseville, California
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
Santa Monica, California
Study site
Sarasota, Florida
Study site
Tucson, Arizona
Study site
Van Nuys, California
Study site
Vero Beach, Florida
Study site
Waco, Texas
Study site
West Palm Beach, Florida
Study site
Wichita, Kansas
About this study
Official title: A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.
- Conditions
- Osteoarthritis
- Being tested
- Placebo, gevokizumab
- Keywords
- Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution for subcutaneous injection
gevokizumabDrug
Solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| gevokizumab | Experimental | Not described Receives: Drug: gevokizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in AUSCAN pain score at Day 84
The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.
Measured: Baseline and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- XOMA (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882491
- Sponsor's protocol ID
- X052162
- Status last verified
- Mar 2014
- First submitted
- 17 Jun 2013
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand
- ClinicalTrials.gov ID
- NCT01882491
- Acronym / sponsor ID
- X052162
- Conditions
- Osteoarthritis
- Keywords
- Erosive Osteoarthritis, Osteoarthritis, Osteoarthritis of the Hand
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- XOMA (US) LLCIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jun 2013 (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.
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| gevokizumab | Experimental | Drug: gevokizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of hand osteoarthritis
- Joint tenderness and/or redness
- At least one erosion by X-ray (as determined by the central reader)
- Contraceptive measures adequate to prevent pregnancy during the study
Key exclusion criteria (7 listed)
- History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
- History of gout, pseudogout, or hemochromatosis
- History of allergic or anaphylactic reactions to monoclonal antibodies
- History of recurrent or chronic systemic infections
- Known allergy to acetaminophen
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 |
|---|---|---|
| PlaceboSolution for subcutaneous injection | Drug | Placebo |
| gevokizumabSolution for subcutaneous injection | Drug | gevokizumab |
Primary outcome
Percent change from baseline in AUSCAN pain score at Day 84
Time frame: Baseline and Day 84
The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 gevokizumab in people with Osteoarthritis, run by XOMA (US) LLC at 23 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change from baseline in AUSCAN pain score at Day 84 (time frame: Baseline and Day 84). 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 4 Mar 2014; AzTrials last refreshed its copy on 8 Nov 2026.