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

This study is currently recruiting participants.
Verified February 2013 by XOMA (US) LLC
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01683396
First received: September 6, 2012
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis
 Drug: Placebo
Drug: gevokizumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by XOMA (US) LLC:

Primary Outcome Measures:
  • Percent change from baseline in AUSCAN pain score at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
    The Australian/Canadian (AUSCAN) Osteoarthritis Hand Index is a self-report assessment of pain, stiffness, and function in patients with hand osteoarthritis.


Estimated Enrollment: 90
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Solution for subcutaneous injection
Experimental: gevokizumab Drug: gevokizumab
Solution for subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683396

Contacts
Contact: Rajneesh Nath, MD 650-388-6308

  Show 24 Study Locations
Sponsors and Collaborators
XOMA (US) LLC
  More Information

No publications provided

Responsible Party: XOMA (US) LLC
ClinicalTrials.gov Identifier: NCT01683396     History of Changes
Other Study ID Numbers: X052160
Study First Received: September 6, 2012
Last Updated: February 28, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013