(C2013-0302) Safety and Efficacy of Escalating Doses of SAN-300 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Phase 2a multiple ascending dose, Anti-Very Late Antigen-1

Summary:

      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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosed with RA for ≥ 6 months according to American College of Rheumatology
             (ACR)/European League Against Rheumatism (EULAR) Classification Criteria 2010

          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:

          1. Functional Class IV as defined by ACR classification of functional status in RA

          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)