(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Escalating Doses of SAN-300 in Patients with Active Rheumatoid Arthritis with Inadequate Response to Disease-Modifying Anti-rheumatic Drug(s).

Key facts

Study ID

NCT02047604

Run by

Bausch Health Americas, Inc.

People needed

41

Starts

2013-12-01

Expected to finish

2017-03-23

Last updated by the study team

2021-06-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with RA for ≥ 6 months according to American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010
• 18 to 75 years of age, inclusive, at the time of informed consent
• Swollen joint count of ≥ 6 (66-joint count) and tender joint count of ≥ 6 (68-joint count) at Screening and randomization
• 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)
• Stable dose of methotrexate (≥ 15 mg/week and ≤ 25 mg/week) for ≥ 6 weeks before randomization

You may not qualify if…

• Functional Class IV as defined by ACR classification of functional status in RA
• History of significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty's syndrome)
• 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
• 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
• History of recurrent clinically significant infections
• Current active infection or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months before randomization
• History of severe allergic or anaphylactic reactions to other biologic agents
• History of allergies to murine protein
• 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
• History of tuberculosis or latent infection currently undergoing treatment
• History of malaria
• 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
• Intra-articular corticosteroid injection(s) within 4 weeks before randomization
• Any live immunization/vaccination, including against Herpes zoster, within 4 weeks before randomization. Live vaccinations must also be avoided throughout the study
• Abnormal laboratory value at Screening or Day -1 considered clinically significant
• Positive for hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg)
• Positive for human immunodeficiency virus (HIV) antibody
• History of tuberculosis or positive QuantiFERON®-TB Gold test (QFT)

Where it is running

• 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

Full record on ClinicalTrials.gov

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