(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
NCT ID: NCT02047604
Last Updated: 2021-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2013-12-31
2017-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort A - SAN-300 0.5 mg/kg QW
SAN-300 0.5 mg/kg subcutaneous once weekly for six weeks
SAN-300 0.5 mg/kg QW
Cohort B - SAN-300 1.0 mg/kg QW
SAN-300 1.0 mg/kg subcutaneous once weekly for six weeks
SAN-300 1.0 mg/kg QW
Cohort C - SAN-300 2.0 mg/kg QOW
SAN-300 2.0 mg/kg subcutaneous every other week for six weeks
SAN-300 2.0 mg/kg QOW
Cohort D - SAN-300 4.0 mg/kg QOW
SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
SAN-300 4.0 mg/kg QOW
Cohort E - SAN-300 4.0 mg/kg QW
SAN-300 4.0 mg/kg subcutaneous every other week for six weeks
SAN-300 4.0 mg/kg QW
Placebo
Placebo dosing
Placebo
Interventions
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SAN-300 0.5 mg/kg QW
SAN-300 1.0 mg/kg QW
SAN-300 2.0 mg/kg QOW
SAN-300 4.0 mg/kg QOW
SAN-300 4.0 mg/kg QW
Placebo
Eligibility Criteria
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Inclusion Criteria
2. 18 to 75 years of age, inclusive, at the time of informed consent
3. Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
4. Inadequate response to therapy or discontinuation of therapy because of unacceptable toxicity from at least one prior traditional or biologic disease-modifying anti-rheumatic drug (DMARD)
5. Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization
Exclusion Criteria
2. History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
3. History of malignancy or carcinoma in situ within the 5 years before Screening or any history of melanoma. Patients with history of excised or adequately treated non-melanoma skin cancer are eligible
4. Evidence of clinically significant uncontrolled concurrent diseases such as cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases
5. History of recurrent clinically significant infections
6. Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
7. History of severe allergic or anaphylactic reactions to other biologic agents
8. History of allergies to murine protein
9. Surgery within 3 months before randomization (other than minor cosmetic surgery or minor dental procedures) or plans for a surgical procedure during the Treatment Period or Follow-up Period
10. History of tuberculosis or latent infection currently undergoing treatment
11. History of malaria
12. Treatment regimen with prednisone that is either over 10 mg/day (or equivalent dose of another corticosteroid) or is not taken at a stable dose of ≤ 10 mg/day for at least 4 weeks before randomization
13. Intra-articular corticosteroid injection(s) within 4 weeks before randomization
14. Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
15. Abnormal laboratory value at Screening or Day -1 considered clinically significant
16. Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
17. Positive for human immunodeficiency virus (HIV) antibody
18. History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)
18 Years
75 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Locations
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Santarus Clinical Investigational Site 1012
Phoenix, Arizona, United States
Santarus Clinical Investigational Site 1004
El Cajon, California, United States
Santarus Clinical Investigational Site 1008
Los Angeles, California, United States
Santarus Clinical Investigational Site 1011
San Leandro, California, United States
Santarus Clinical Investigational Site 1013
Brandon, Florida, United States
Santarus Clinical Investigational Site 1003
Palm Harbor, Florida, United States
Santarus Clinical Investigational Site 1017
Florissant, Missouri, United States
Santarus Clinical Investigational Site 1009
Brooklyn, New York, United States
Santarus Clinical Investigational Site 1019
Chapel Hill, North Carolina, United States
Santarus Clinical Investigational Site 1014
Charlotte, North Carolina, United States
Santarus Clinical Investigational Site 1006
Salisbury, North Carolina, United States
Santarus Clinical Investigational Site 1001
Middleburg Heights, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-003719-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C2013-0302
Identifier Type: -
Identifier Source: org_study_id
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