Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 2, Randomized, Placebo‑Controlled, Dose‑Ranging Study to Evaluate the Safety and Efficacy of the Anti-GM-CSF Monoclonal Antibody KB003 in Subjects With Active Rheumatoid Arthritis and Inadequate Prior Treatment Outcome From Biologic Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00995449
• Other study ID #: KB003-02
• Status: Terminated
• Phase: Phase 2
• First received: October 5, 2009
• Last updated: June 4, 2014
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2014
• Source: KaloBios Pharmaceuticals
• 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 safety, pharmacokinetics (PK), and efficacy of various repeat-dose regimens of KB003 in subjects with active Rheumatoid Arthritis (RA) who have had an inadequate prior treatment outcome from biologic therapy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 6 swollen and at least 6 tender joints

• C-reactive Protein (CRP) > Upper Limit Normal (ULN)

• Prior inadequate response from biologic therapy

• Stable regimens of concomitant RA therapies

Exclusion Criteria:

• Unstable medical conditions

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• KB003
KB003 IV x5 doses

Other:
• Placebo Comparator
Placebo IV x5 doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KaloBios Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety.	KB003 was administered by intravenous (IV) infusion as a 600 mg dose at weeks 0, 2, 4, 8, and 12, with primary safety being evaluated at week 14 and a follow-up (end of study) safety assessment at week 30. Safety was evaluated by number of participants with treatment-emergent (TE) adverse events (AEs). (TE is defined as ocurring during the 14 week treatment and week 30 follow-up periods)	Weeks 14 & 30	Yes