Study of KB003 In Biologics-Inadequate Rheumatoid Arthritis
This study has been terminated.
(Program refocus)
Sponsor:
KaloBios Pharmaceuticals
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
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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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
MedlinePlus related topics:
Rheumatoid Arthritis
Drug Information available for:
Sargramostim
U.S. FDA Resources
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 ] [ 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)
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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, 63141 | |
| St. Louis, Missouri, United States, 63117 | |
| 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
No publications provided
| Responsible Party: | KaloBios Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00995449 History of Changes |
| Other Study ID Numbers: | KB003-02 |
| Study First Received: | October 5, 2009 |
| Results First Received: | May 7, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013