Open-label Safety Extension Study of Gevokizumab in Erosive Osteoarthritis of the Hand

• Sponsor: XOMA (US) LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02293564
• Collaborator: (none)
• Enrollment: 312
• Locations: 28
• Arm: 1
• Patients Per Site: 11.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety of gevokizumab in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: gevokizumab	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gevokizumab	Drug: gevokizumab; Solution for subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Treatment-emergent adverse events [Up to two years]

   Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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 erosive osteoarthritis (EOA) including: secondary post-traumatic osteoarthritis (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

• 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

Locations

	Site	City	State	Country	Postal Code
1		Tucson	Arizona	United States
2		Little Rock	Arkansas	United States
3		Roseville	California	United States
4		Sacramento	California	United States
5		Santa Monica	California	United States
6		Boulder	Colorado	United States
7		Denver	Colorado	United States
8		Miami	Florida	United States
9		Pinellas Park	Florida	United States
10		Tampa	Florida	United States
11		Vero Beach	Florida	United States
12		West Palm Beach	Florida	United States
13		Indianapolis	Indiana	United States
14		Wichita	Kansas	United States
15		Hagerstown	Maryland	United States
16		Wheaton	Maryland	United States
17		Reno	Nevada	United States
18		Albuerque	New Mexico	United States
19		Raleigh	North Carolina	United States
20		Portland	Oregon	United States
21		Duncansville	Pennsylvania	United States
22		Austin	Texas	United States
23		Dallas	Texas	United States
24		San Antonio	Texas	United States
25		Waco	Texas	United States
26		Charlottesville	Virginia	United States
27		Norfolk	Virginia	United States
28		Franklin	Wisconsin	United States

Sponsors and Collaborators

• XOMA (US) LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: XOMA (US) LLC
• ClinicalTrials.gov Identifier: NCT02293564
• Other Study ID Numbers: X052161
• First Posted: Nov 18, 2014
• Last Update Posted: Feb 19, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by XOMA (US) LLC: Erosive Osteoarthritis; Osteoarthritis; Osteoarthritis of the Hand
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of Feb 19, 2015