Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

This study has been terminated.
(Program refocus)
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00995449
First received: October 5, 2009
Last updated: February 1, 2013
Last verified: February 2013

October 5, 2009
February 1, 2013
January 2010
March 2011   (final data collection date for primary outcome measure)
This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. [ Time Frame: Weeks 14 & 30 ] [ Designated as safety issue: Yes ]
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)
American College of Rheumatology 20% improvement criteria (ACR20) Response [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00995449 on ClinicalTrials.gov Archive Site
Not Provided
  • DAS28 (Disease Activity Score) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Disease response based on European League Against Rheumatism (EULAR) criteria [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
  • Serum concentrations of KB003 (Pharmacokinetics) [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Week 30 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: KB003
    KB003 IV x5 doses
    Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
  • Other: Placebo Comparator
    Placebo IV x5 doses
  • Experimental: KB003 70 mg
    Intervention: Biological: KB003
  • Experimental: KB003 200 mg
    Intervention: Biological: KB003
  • Experimental: KB003 600 mg
    Intervention: Biological: KB003
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
February 2012
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995449
KB003-02
Yes
KaloBios Pharmaceuticals
KaloBios Pharmaceuticals
Not Provided
Study Chair: Nestor A. Molfino, MD, MSC KaloBios Pharmaceuticals
KaloBios Pharmaceuticals
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP