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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
XOMA (US) LLC
ClinicalTrials.gov Identifier:
NCT01683396
First received: September 6, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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:


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.


Enrollment: 87
Study Start Date: July 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 27 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: March 3, 2014
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 August 18, 2014