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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01683396
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 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 Active Inflammatory, Erosive Osteoarthritis of the Hand
Study Start Date : July 2012
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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01683396

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Sponsors and Collaborators

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Responsible Party: XOMA (US) LLC Identifier: NCT01683396     History of Changes
Other Study ID Numbers: X052160
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases