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Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

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ClinicalTrials.gov Identifier: NCT01882491
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Placebo Drug: gevokizumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Solution for subcutaneous injection
Experimental: gevokizumab Drug: gevokizumab
Solution for subcutaneous injection



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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


Information from the National Library of Medicine

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): NCT01882491


Locations
United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Roseville, California, United States
Sacramento, California, United States
Santa Monica, California, United States
Van Nuys, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
Vero Beach, Florida, United States
West Palm Beach, Florida, United States
United States, Kansas
Wichita, Kansas, United States
United States, Nevada
Reno, Nevada, United States
United States, North Carolina
Raleigh, North Carolina, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
United States, Wisconsin
Franklin, Wisconsin, United States
Sponsors and Collaborators
XOMA (US) LLC

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01882491     History of Changes
Other Study ID Numbers: X052162
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by XOMA (US) LLC:
Erosive Osteoarthritis
Osteoarthritis
Osteoarthritis of the Hand

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases