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

Osteoarthritis Clinical Trial

Official title:

An Open-label Safety Extension Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293564
• Other study ID #: X052161
• Status: Completed
• Phase: N/A
• First received: November 11, 2014
• Last updated: February 17, 2015
• Start date: March 2013

Study information

• Verified date: February 2015
• Source: XOMA (US) LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• gevokizumab
Solution for subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
XOMA (US) LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events	Safety analyses will involve examination of the incidence, severity, and type of treatment-emergent adverse events reported.	Up to two years	Yes