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Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis

This study has been terminated.
(Program refocus)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00995449
First Posted: October 15, 2009
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Biological: KB003 Other: Placebo Comparator Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • This Study Was Initiated With a Safety run-in Period to Evaluate Acceptability of Repeat-dose Safety. [ Time Frame: Weeks 14 & 30 ]
    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)


Enrollment: 9
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KB003 70 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 200 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Experimental: KB003 600 mg Biological: KB003
KB003 IV x5 doses
Other Name: Recombinant anti-GM-CSF IgG1K monoclonal antibody
Placebo Comparator: Placebo Other: Placebo Comparator
Placebo IV x5 doses

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995449


Locations
United States, California
Stanford, California, United States, 94304
Westlake Village, California, United States, 91361
United States, Florida
Miami, Florida, United States, 33143
United States, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Maryland
Frederick, Maryland, United States, 21702
Wheaton, Maryland, United States, 20902
United States, Missouri
St. Louis, Missouri, United States, 63117
St. Louis, Missouri, United States, 63141
United States, North Carolina
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Tulsa, Oklahoma, United States, 74135
United States, Wisconsin
Oak Creek, Wisconsin, United States, 53154
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Study Chair: Nestor A. Molfino, MD, MSC KaloBios Pharmaceuticals
  More Information

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00995449     History of Changes
Other Study ID Numbers: KB003-02
First Submitted: October 5, 2009
First Posted: October 15, 2009
Results First Submitted: May 7, 2012
Results First Posted: September 25, 2012
Last Update Posted: June 9, 2014
Last Verified: June 2014

Keywords provided by KaloBios Pharmaceuticals:
Rheumatoid Arthritis
Biologics-Inadequate
KB003
GM-CSF

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs